Antibacterial and antimycobacterial products for systemic use

Finnish Institute for Health and Welfare, later referred to as THL or Customer, request your tender for "Antibacterial and antimycobacterial products for systemic use" to the rescEU Medical -project. The Scope of procurement is described in more detail in Annex 1. The procurement is divided in ten (10) lots. Each …

CPV: 33651000 Antiinfecciosos generales para uso sistémico, vacunas, 33600000 Productos farmacéuticos, 33651100 Antibacterianos para uso sistémico, 33651300 Antimicobacterianos
Plazo:
20 de noviembre de 2024 a las 10:00
Tipo de plazo:
Presentación de una oferta
Lugar de ejecución:
Antibacterial and antimycobacterial products for systemic use
Organismo adjudicador:
Finnish Institute for Health and Welfare
Número de premio:
THL/5372/2.02.06/2024

1. Buyer

1.1 Buyer

Official name : Finnish Institute for Health and Welfare
Legal type of the buyer : Central government authority
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : Antibacterial and antimycobacterial products for systemic use
Description : Finnish Institute for Health and Welfare, later referred to as THL or Customer, request your tender for "Antibacterial and antimycobacterial products for systemic use" to the rescEU Medical -project. The Scope of procurement is described in more detail in Annex 1. The procurement is divided in ten (10) lots. Each product constitutes a separate lot. Tender may be submitted for one or several lots. LOT 1: Linezolid 2 mg/ml (300 ml, i.v. solution, ATC J01XX08) LOT 2: Pyrazinamide 500 mg (tablet/capsule, oral, ATC J04AK01) LOT 3: Etambuthol 500 mg (tablet/capsule, oral, ATC J04AK02) LOT 4: Clindamycin 300 mg (tablet/capsule, oral, ATC J01FF01) LOT 5: Isoniazide 300 mg (tablet/capsule, oral, ATC J04AC01) LOT 6: Claritromycin 250 mg (tablet/capsule, oral, ATC J01FA09) LOT 7: Clindamycin 15 mg/ml (80 ml, oral suspension, ATC J01FF01) LOT 8: Moxifloxacin 400 mg (tablet/capsule, oral, ATC J01MA14) LOT 9: Levofloxacin 500 mg (tablet/capsule, oral, ATC J01MA12) LOT 10: Claritromycin oral suspension 50 mg/ml (50 ml, oral suspension ATC J01FA09) The minimum requirements for the products is described in Annex 1.1. The Contract will be awarded to one Supplier for each lot based on a comparison of tenders. Tender that is economically the most advantageous will win the competition. The contract period shall enter into force once the Contract has been signed by contracting parties and expires when all contractual duties of the Contract have been performed. Quantity for the products is described in Annex 7 (restricted to security classification level IV, TL IV). In addition to the quantity indicated in the Annex 7, the Customer is entitled to purchase 100 % extra to the quantities (later referred as "Option"). The Supplier is not obliged to deliver the products under the Option. Please note that all times given in the Call for tenders refer to local time in Finland. Call for tenders, Annexes: Annex 1 Scope of the procurement Annex 1.1 Minimum requirements Annex 2 Description of the rotation Annex 2.1 Quality scoring table Annex 3 Contract Annex 4 Security annex Annex 5 JYSE 2014 SUPPLIES (updated version of April 2022) Annex 6 Confidentiality commitment Annex 7 Quantity of the Articles (restricted, TL IV) Please note that the numbering of the annexes differs between the Contract and the Call for tenders. The numbering of the Annexes to the Contract is based on the order of precedence applied in the Contract.
Procedure identifier : 96c79768-2328-4b42-99ad-044d1e25bf60
Internal identifier : THL/5372/2.02.06/2024
Type of procedure : Open
The procedure is accelerated : no
Justification for the accelerated procedure :
Main features of the procedure : Tenders must be submitted electronically via the Cloudia Supplier Portal. It is the responsibility of the tenderer to submit the tender by the deadline. No compensation will be paid for submitting a tender. Requirements concerning tenderers and the Article, as well as eventual reports and explanations required in the tender, are described in this Call for tenders. All the attachments mentioned in the Call for tenders should be sent with the tender. The tender must be submitted in writing, in English. Also, the annexes and all related material or correspondence must be in English. The process steps are: 1. Opening the tenders. 2. Inspecting the suitability of tenderers according to the ESPD form. 3. Inspecting that tenders meet the requirements set in the Call for tenders. 4. Comparison of tenders. 5. Making and announcing the Procurement decision. 6. Verifying the information given by the awarded tenderer on the ESPD form. 7. Background check by asking the winning tenderer to submit criminal record exctracts. 8. Drafting the Contract. The Contract is only valid after a written Contract is signed. The Contract can be signed no earlier than 14 days from the time the tenderer has been informed, or is considered to have been informed, of the Procurement decision and its grounds (= stand-still period).

2.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651000 General anti-infectives for systemic use and vaccines
Additional classification ( cpv ): 33600000 Pharmaceutical products

2.1.2 Place of performance

Country : Finland
Anywhere in the given country

2.1.4 General information

Additional information : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Legal basis :
Directive 2014/24/EU

2.1.5 Terms of procurement

Terms of submission :
Maximum number of lots for which one tenderer can submit tenders : 10
Terms of contract :
Maximum number of lots for which contracts can be awarded to one tenderer : 10

2.1.6 Grounds for exclusion

Analogous situation like bankruptcy under national law : The economic operator is in any analogous situation like bankruptcy arising from a similar procedure under national laws and regulations.
Bankruptcy : The economic operator is bankrupt.
Corruption : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for corruption, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.
Arrangement with creditors : The economic operator is in arrangement with creditors.
Participation in a criminal organisation : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for participation in a criminal organisation, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.
Agreements with other economic operators aimed at distorting competition : The economic operator has entered into agreements with other economic operators aimed at distorting competition.
Breaching of obligations in the fields of environmental law : The economic operator has breached its obligations in the field of environmental law.
Money laundering or terrorist financing : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for money laundering or terrorist financing, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.
Fraud : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for fraud, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.
Child labour and other forms of trafficking in human beings : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for child labour and other forms of trafficking in human beings, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.
Insolvency : The economic operator is the subject of insolvency or winding-up.
Breaching of obligations in the fields of labour law : The economic operator has breached its obligations in the field of labour law.
Assets being administered by liquidator : The assets of the economic operator are being administered by a liquidator or by the court.
Guilty of misrepresentation, withheld information, unable to provide required documents and obtained confidential information of this procedure : The economic operator can confirm that: a) It has been guilty of serious misrepresentation in supplying the information required for the verification of the absence of grounds for exclusion or the fulfilment of the selection criteria, b) It has withheld such information, c) It has not been able, without delay, to submit the supporting documents required by a contracting authority or contracting entity, and d) It has undertaken to unduly influence the decision making process of the contracting authority or contracting entity, to obtain confidential information that may confer upon it undue advantages in the procurement procedure or to negligently provide misleading information that may have a material influence on decisions concerning exclusion, selection or award.
Purely national exclusion grounds : Any person who is a member of the economic operator’s administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for work safety offence, working hours offence, work discrimination, extortionate work discrimination, violation of the right to organise or unauthorised use of foreign labour.
Conflict of interest due to its participation in the procurement procedure : The economic operator is aware of any conflict of interest, as indicated in national law, the relevant notice or the procurement documents due to its participation in the procurement procedure.
Direct or indirect involvement in the preparation of this procurement procedure : The economic operator or an undertaking related to it has advised the contracting authority or contracting entity or otherwise been involved in the preparation of the procurement procedure.
Guilty of grave professional misconduct : The economic operator is guilty of grave professional misconduct.
Early termination, damages or other comparable sanctions : The economic operator has experienced that a prior public contract, a prior contract with a contracting entity or a prior concession contract was terminated early, or that damages or other comparable sanctions were imposed in connection with that prior contract.
Breaching of obligations in the fields of social law : The economic operator has breached its obligations in the field of social law.
Payment of social security contributions : The economic operator has breached its obligations relating to the payment social security contributions, both in the country in which it is established and in Member State of the contracting authority or contracting entity if other than the country of establishment.
Business activities are suspended : The business activities of the economic operator are suspended.
Payment of taxes : The economic operator has breached its obligations relating to the payment of taxes, both in the country in which it is established and in Member State of the contracting authority or contracting entity if other than the country of establishment.
Terrorist offences or offences linked to terrorist activities : The economic operator itself or any person who is a member of its administrative, management or supervisory body or has powers of representation, decision or control therein has been the subject of a conviction by final judgment for terrorist offences or offences linked to terrorist activities, by a conviction rendered at the most five years ago or in which an exclusion period set out directly in the conviction continues to be applicable.

5. Lot

5.1 Lot technical ID : LOT-0001

Title : LOT 1: Linezolid 2 mg/ml (300 ml, i.v. solution, ATC J01XX08)
Description : The subject of the procurement is Article in accordance with the following requirements: - The subject of tender: Linezolid 2 mg/ml (300 ml, i.v. solution, ATC J01XX08) - Parenteral products (intravenous administration) - Active pharmaceutical ingredient: Linezolid - Strength: 2 mg / ml - Pharmaceutical form: 300 ml infusion bag The minimum requirements of the Article is described in more detail in Annex 1.1. The delivery schedule for the articles is described in Annex 1. Quantity for the Article is described in Annex 7 (restricted, TL IV). In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer. The Contract will be awarded to one Supplier based on a comparison of tenders. Tender that is economically the most advantageous will win the competition.
Internal identifier : 1

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651100 Antibacterials for systemic use
Options :
Description of the options : In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer.

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Duration : 13 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : Union Civil Protection Mechanism (rescEU) (2021/2027)
Identifier of EU funds : rescEU-MED-CBRN-FI
Further details of EU funds : rescEU - Medical Stockpiling in Finland
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : The tenderer´s financial prerequisites are sufficient with regard to the size and nature of the procurement. In order that the tenderer may be estimated to be able to provide and deliver the Articles subject to procurement, the Customer requires that the tenderer´s turnover each of the two (2) previous accounting years (2022 and 2023) have been at least one million euros (1 000 000 EUR).
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a trade register
Description : It is enrolled in the relevant trade registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability

5.1.10 Award criteria

Criterion :
Type : Price
Name : Reference price
Description : The reference price of the tender consists of the price of one (1) unit of the Article (exclusive of VAT). The offered price includes the Articles and transport according to the Call for tenders and covers all requirements set out in the Call for tenders and it's Annexes. There shall be no additional costs for the THL. The lowest reference price will get maximum price score. Other tenderers will get price score according to the following price score calculation formula: the lowest reference price / tendered reference price * maximum price score (50).
Weight (points, exact) : 50
Criterion :
Type : Quality
Name : Quality 1: Registered shelf life of the Article
Description : The offered Article has as long as possible registered shelf life. A shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 2: Delivery time to the Customer’s warehouse
Description : 50 % of the total quantity should be delivered as soon as possible. The faster the tenderer can deliver 50 % of the total quantity, the more points it will receive according to the menus in the Call for tenders. A maximum of 15 points can be achieved.
Weight (points, exact) : 15
Criterion :
Type : Quality
Name : Quality 3: Transportation temperature and excursions
Description : If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the tenderer receives 3 points. The tenderer shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.
Weight (points, exact) : 3
Criterion :
Type : Quality
Name : Quality 4: Marketing authorisation valid in Finland and Finnish language of packaging
Description : If the Article offered has marketing authorisation valid in Finland (national or EMA centralized EU Marketing Authorisation) and Finnish language packaging material inspected and reviewed by the competent authority, the supplier receives 10 points.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 5: Rotation plan for the Article
Description : Tenderer has a possibility to achieve a maximum of 12 quality points by submitting a rotation plan to avoid unnecessary disposal of medicinal products in accordance with the Annex 2. The rotation plan shall fulfill the requirements set out in the annex 2. A panel of THL experts will evaluate the tenderer's rotation plan according to the scoring table described in the Annex 2.1. The tenderer will receive quality points according to the following formula: Expert panel score / 5 (number of scoring criteria).
Weight (points, exact) : 12
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Access to certain procurement documents is restricted
Justification for restricting access to certain procurement documents : Protection of particularly sensitive information
Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 06/11/2024 10:00 +00:00
Information about restricted documents is available at : https://tarjouspalvelu.fi/thl?id=530415&tpk=e761e1cb-3b59-453c-b575-a799b1e76a09

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 20/11/2024 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 20/11/2024 10:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : For further details please see the documents of the Call for tenders.
A non-disclosure agreement is required : yes
Additional information about the non-disclosure agreement : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
Organisation providing additional information about the procurement procedure : Finnish Institute for Health and Welfare
Organisation receiving requests to participate : Finnish Institute for Health and Welfare
Organisation processing tenders : Finnish Institute for Health and Welfare
TED eSender : Hansel Oy (Hilma)

5.1 Lot technical ID : LOT-0002

Title : LOT 2: Pyrazinamide 500 mg (tablet/capsule, oral, ATC J04AK01)
Description : The subject of the procurement is Article in accordance with the following requirements: - The subject of tender: Pyrazinamide 500 mg (tablet/capsule, oral, ATC J04AK01) - Oral solid dosage forms - Active pharmaceutical ingredient: Pyrazinamide - Strength: 500 mg - Pharmaceutical form: Tablet/capsule The minimum requirements of the Article is described in more detail in Annex 1.1. The delivery schedule for the articles is described in Annex 1. Quantity for the Article is described in Annex 7 (restricted, TL IV). In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer. The Contract will be awarded to one Supplier based on a comparison of tenders. Tender that is economically the most advantageous will win the competition.
Internal identifier : 2

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651300 Antimycobacterials
Options :
Description of the options : In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer.

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Duration : 13 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : Union Civil Protection Mechanism (rescEU) (2021/2027)
Identifier of EU funds : rescEU-MED-CBRN-FI
Further details of EU funds : rescEU - Medical Stockpiling in Finland
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : The tenderer´s financial prerequisites are sufficient with regard to the size and nature of the procurement. In order that the tenderer may be estimated to be able to provide and deliver the Articles subject to procurement, the Customer requires that the tenderer´s turnover each of the two (2) previous accounting years (2022 and 2023) have been at least one million euros (1 000 000 EUR).
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a trade register
Description : It is enrolled in the relevant trade registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability

5.1.10 Award criteria

Criterion :
Type : Price
Name : Reference price
Description : The reference price of the tender consists of the price of one (1) unit of the Article (exclusive of VAT). The offered price includes the Articles and transport according to the Call for tenders and covers all requirements set out in the Call for tenders and it's Annexes. There shall be no additional costs for the THL. The lowest reference price will get maximum price score. Other tenderers will get price score according to the following price score calculation formula: the lowest reference price / tendered reference price * maximum price score (50).
Weight (points, exact) : 50
Criterion :
Type : Quality
Name : Quality 1: Registered shelf life of the Article
Description : The offered Article has as long as possible registered shelf life. A shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 2: Delivery time to the Customer’s warehouse
Description : 50 % of the total quantity should be delivered as soon as possible. The faster the tenderer can deliver 50 % of the total quantity, the more points it will receive according to the menus in the Call for tenders. A maximum of 15 points can be achieved.
Weight (points, exact) : 15
Criterion :
Type : Quality
Name : Quality 3: Transportation temperature and excursions
Description : If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the tenderer receives 3 points. The tenderer shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.
Weight (points, exact) : 3
Criterion :
Type : Quality
Name : Quality 4: Marketing authorisation valid in Finland and Finnish language of packaging
Description : If the Article offered has marketing authorisation valid in Finland (national or EMA centralized EU Marketing Authorisation) and Finnish language packaging material inspected and reviewed by the competent authority, the supplier receives 10 points.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 5: Rotation plan for the Article
Description : Tenderer has a possibility to achieve a maximum of 12 quality points by submitting a rotation plan to avoid unnecessary disposal of medicinal products in accordance with the Annex 2. The rotation plan shall fulfill the requirements set out in the annex 2. A panel of THL experts will evaluate the tenderer's rotation plan according to the scoring table described in the Annex 2.1. The tenderer will receive quality points according to the following formula: Expert panel score / 5 (number of scoring criteria).
Weight (points, exact) : 12
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Access to certain procurement documents is restricted
Justification for restricting access to certain procurement documents : Protection of particularly sensitive information
Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 06/11/2024 10:00 +00:00
Information about restricted documents is available at : https://tarjouspalvelu.fi/thl?id=530415&tpk=e761e1cb-3b59-453c-b575-a799b1e76a09

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 20/11/2024 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 20/11/2024 10:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : For further details please see the documents of the Call for tenders.
A non-disclosure agreement is required : yes
Additional information about the non-disclosure agreement : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
Organisation providing additional information about the procurement procedure : Finnish Institute for Health and Welfare
Organisation receiving requests to participate : Finnish Institute for Health and Welfare
Organisation processing tenders : Finnish Institute for Health and Welfare
TED eSender : Hansel Oy (Hilma)

5.1 Lot technical ID : LOT-0003

Title : LOT 3: Etambuthol 500 mg (tablet/capsule, oral, ATC J04AK02)
Description : The subject of the procurement is Article in accordance with the following requirements: - The subject of tender: Etambuthol 500 mg (tablet/capsule, oral, ATC J01FF01) - Oral solid dosage forms - Active pharmaceutical ingredient: Etambuthol - Strength: 500 mg - Pharmaceutical form: Tablet/capsule The minimum requirements of the Article is described in more detail in Annex 1.1. The delivery schedule for the articles is described in Annex 1. Quantity for the Article is described in Annex 7 (restricted, TL IV). In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer. The Contract will be awarded to one Supplier based on a comparison of tenders. Tender that is economically the most advantageous will win the competition.
Internal identifier : 3

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651300 Antimycobacterials
Options :
Description of the options : In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer.

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Duration : 13 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : Union Civil Protection Mechanism (rescEU) (2021/2027)
Identifier of EU funds : rescEU-MED-CBRN-FI
Further details of EU funds : rescEU - Medical Stockpiling in Finland
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : The tenderer´s financial prerequisites are sufficient with regard to the size and nature of the procurement. In order that the tenderer may be estimated to be able to provide and deliver the Articles subject to procurement, the Customer requires that the tenderer´s turnover each of the two (2) previous accounting years (2022 and 2023) have been at least one million euros (1 000 000 EUR).
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a trade register
Description : It is enrolled in the relevant trade registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability

5.1.10 Award criteria

Criterion :
Type : Price
Name : Reference price
Description : The reference price of the tender consists of the price of one (1) unit of the Article (exclusive of VAT). The offered price includes the Articles and transport according to the Call for tenders and covers all requirements set out in the Call for tenders and it's Annexes. There shall be no additional costs for the THL. The lowest reference price will get maximum price score. Other tenderers will get price score according to the following price score calculation formula: the lowest reference price / tendered reference price * maximum price score (50).
Weight (points, exact) : 50
Criterion :
Type : Quality
Name : Quality 1: Registered shelf life of the Article
Description : The offered Article has as long as possible registered shelf life. A shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 2: Delivery time to the Customer’s warehouse
Description : 50 % of the total quantity should be delivered as soon as possible. The faster the tenderer can deliver 50 % of the total quantity, the more points it will receive according to the menus in the Call for tenders. A maximum of 15 points can be achieved.
Weight (points, exact) : 15
Criterion :
Type : Quality
Name : Quality 3: Transportation temperature and excursions
Description : If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the tenderer receives 3 points. The tenderer shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.
Weight (points, exact) : 3
Criterion :
Type : Quality
Name : Quality 4: Marketing authorisation valid in Finland and Finnish language of packaging
Description : If the Article offered has marketing authorisation valid in Finland (national or EMA centralized EU Marketing Authorisation) and Finnish language packaging material inspected and reviewed by the competent authority, the supplier receives 10 points.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 5: Rotation plan for the Article
Description : Tenderer has a possibility to achieve a maximum of 12 quality points by submitting a rotation plan to avoid unnecessary disposal of medicinal products in accordance with the Annex 2. The rotation plan shall fulfill the requirements set out in the annex 2. A panel of THL experts will evaluate the tenderer's rotation plan according to the scoring table described in the Annex 2.1. The tenderer will receive quality points according to the following formula: Expert panel score / 5 (number of scoring criteria).
Weight (points, exact) : 12
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Access to certain procurement documents is restricted
Justification for restricting access to certain procurement documents : Protection of particularly sensitive information
Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 06/11/2024 10:00 +00:00
Information about restricted documents is available at : https://tarjouspalvelu.fi/thl?id=530415&tpk=e761e1cb-3b59-453c-b575-a799b1e76a09

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 20/11/2024 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 20/11/2024 10:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : For further details please see the documents of the Call for tenders.
A non-disclosure agreement is required : yes
Additional information about the non-disclosure agreement : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
Organisation providing additional information about the procurement procedure : Finnish Institute for Health and Welfare
Organisation receiving requests to participate : Finnish Institute for Health and Welfare
Organisation processing tenders : Finnish Institute for Health and Welfare
TED eSender : Hansel Oy (Hilma)

5.1 Lot technical ID : LOT-0004

Title : LOT 4: Clindamycin 300 mg (tablet/capsule, oral, ATC J01FF01)
Description : The subject of the procurement is Article in accordance with the following requirements: - The subject of tender: Clindamycin 300 mg (tablet/capsule, oral, ATC J01FF01) - Oral solid dosage forms - Active pharmaceutical ingredient: Clindamycin - Strength: 300 mg - Pharmaceutical form: Tablet/capsule The minimum requirements of the Article is described in more detail in Annex 1.1. The delivery schedule for the articles is described in Annex 1. Quantity for the Article is described in Annex 7 (restricted, TL IV). In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer. The Contract will be awarded to one Supplier based on a comparison of tenders. Tender that is economically the most advantageous will win the competition.
Internal identifier : 4

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651100 Antibacterials for systemic use
Options :
Description of the options : In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer.

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Duration : 13 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : Union Civil Protection Mechanism (rescEU) (2021/2027)
Identifier of EU funds : rescEU-MED-CBRN-FI
Further details of EU funds : rescEU - Medical Stockpiling in Finland
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : The tenderer´s financial prerequisites are sufficient with regard to the size and nature of the procurement. In order that the tenderer may be estimated to be able to provide and deliver the Articles subject to procurement, the Customer requires that the tenderer´s turnover each of the two (2) previous accounting years (2022 and 2023) have been at least one million euros (1 000 000 EUR).
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a trade register
Description : It is enrolled in the relevant trade registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability

5.1.10 Award criteria

Criterion :
Type : Price
Name : Reference price
Description : The reference price of the tender consists of the price of one (1) unit of the Article (exclusive of VAT). The offered price includes the Articles and transport according to the Call for tenders and covers all requirements set out in the Call for tenders and it's Annexes. There shall be no additional costs for the THL. The lowest reference price will get maximum price score. Other tenderers will get price score according to the following price score calculation formula: the lowest reference price / tendered reference price * maximum price score (50).
Weight (points, exact) : 50
Criterion :
Type : Quality
Name : Quality 1: Registered shelf life of the Article
Description : The offered Article has as long as possible registered shelf life. A shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 2: Delivery time to the Customer’s warehouse
Description : 50 % of the total quantity should be delivered as soon as possible. The faster the tenderer can deliver 50 % of the total quantity, the more points it will receive according to the menus in the Call for tenders. A maximum of 15 points can be achieved.
Weight (points, exact) : 15
Criterion :
Type : Quality
Name : Quality 3: Transportation temperature and excursions
Description : If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the tenderer receives 3 points. The tenderer shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.
Weight (points, exact) : 3
Criterion :
Type : Quality
Name : Quality 4: Marketing authorisation valid in Finland and Finnish language of packaging
Description : If the Article offered has marketing authorisation valid in Finland (national or EMA centralized EU Marketing Authorisation) and Finnish language packaging material inspected and reviewed by the competent authority, the supplier receives 10 points.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 5: Rotation plan for the Article
Description : Tenderer has a possibility to achieve a maximum of 12 quality points by submitting a rotation plan to avoid unnecessary disposal of medicinal products in accordance with the Annex 2. The rotation plan shall fulfill the requirements set out in the annex 2. A panel of THL experts will evaluate the tenderer's rotation plan according to the scoring table described in the Annex 2.1. The tenderer will receive quality points according to the following formula: Expert panel score / 5 (number of scoring criteria).
Weight (points, exact) : 12
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Access to certain procurement documents is restricted
Justification for restricting access to certain procurement documents : Protection of particularly sensitive information
Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 06/11/2024 10:00 +00:00
Information about restricted documents is available at : https://tarjouspalvelu.fi/thl?id=530415&tpk=e761e1cb-3b59-453c-b575-a799b1e76a09

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 20/11/2024 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 20/11/2024 10:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : For further details please see the documents of the Call for tenders.
A non-disclosure agreement is required : yes
Additional information about the non-disclosure agreement : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
Organisation providing additional information about the procurement procedure : Finnish Institute for Health and Welfare
Organisation receiving requests to participate : Finnish Institute for Health and Welfare
Organisation processing tenders : Finnish Institute for Health and Welfare
TED eSender : Hansel Oy (Hilma)

5.1 Lot technical ID : LOT-0005

Title : LOT 5: Isoniazide 300 mg (tablet/capsule, oral, ATC J04AC01)
Description : The subject of the procurement is Article in accordance with the following requirements: - The subject of tender: Isoniazide 300 mg (tablet/capsule, oral, ATC J04AC01) - Oral solid dosage forms - Active pharmaceutical ingredient: Isoniazide - Strength: 300 mg - Pharmaceutical form: Tablet/capsule The minimum requirements of the Article is described in more detail in Annex 1.1. The delivery schedule for the articles is described in Annex 1. Quantity for the Article is described in Annex 7 (restricted, TL IV). In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer. The Contract will be awarded to one Supplier based on a comparison of tenders. Tender that is economically the most advantageous will win the competition.
Internal identifier : 5

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651300 Antimycobacterials
Options :
Description of the options : In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer.

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Duration : 13 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : Union Civil Protection Mechanism (rescEU) (2021/2027)
Identifier of EU funds : rescEU-MED-CBRN-FI
Further details of EU funds : rescEU - Medical Stockpiling in Finland
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : The tenderer´s financial prerequisites are sufficient with regard to the size and nature of the procurement. In order that the tenderer may be estimated to be able to provide and deliver the Articles subject to procurement, the Customer requires that the tenderer´s turnover each of the two (2) previous accounting years (2022 and 2023) have been at least one million euros (1 000 000 EUR).
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a trade register
Description : It is enrolled in the relevant trade registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability

5.1.10 Award criteria

Criterion :
Type : Price
Name : Reference price
Description : The reference price of the tender consists of the price of one (1) unit of the Article (exclusive of VAT). The offered price includes the Articles and transport according to the Call for tenders and covers all requirements set out in the Call for tenders and it's Annexes. There shall be no additional costs for the THL. The lowest reference price will get maximum price score. Other tenderers will get price score according to the following price score calculation formula: the lowest reference price / tendered reference price * maximum price score (50).
Weight (points, exact) : 50
Criterion :
Type : Quality
Name : Quality 1: Registered shelf life of the Article
Description : The offered Article has as long as possible registered shelf life. A shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 2: Delivery time to the Customer’s warehouse
Description : 50 % of the total quantity should be delivered as soon as possible. The faster the tenderer can deliver 50 % of the total quantity, the more points it will receive according to the menus in the Call for tenders. A maximum of 15 points can be achieved.
Weight (points, exact) : 15
Criterion :
Type : Quality
Name : Quality 3: Transportation temperature and excursions
Description : If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the tenderer receives 3 points. The tenderer shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.
Weight (points, exact) : 3
Criterion :
Type : Quality
Name : Quality 4: Marketing authorisation valid in Finland and Finnish language of packaging
Description : If the Article offered has marketing authorisation valid in Finland (national or EMA centralized EU Marketing Authorisation) and Finnish language packaging material inspected and reviewed by the competent authority, the supplier receives 10 points.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 5: Rotation plan for the Article
Description : Tenderer has a possibility to achieve a maximum of 12 quality points by submitting a rotation plan to avoid unnecessary disposal of medicinal products in accordance with the Annex 2. The rotation plan shall fulfill the requirements set out in the annex 2. A panel of THL experts will evaluate the tenderer's rotation plan according to the scoring table described in the Annex 2.1. The tenderer will receive quality points according to the following formula: Expert panel score / 5 (number of scoring criteria).
Weight (points, exact) : 12
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Access to certain procurement documents is restricted
Justification for restricting access to certain procurement documents : Protection of particularly sensitive information
Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 06/11/2024 10:00 +00:00
Information about restricted documents is available at : https://tarjouspalvelu.fi/thl?id=530415&tpk=e761e1cb-3b59-453c-b575-a799b1e76a09

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 20/11/2024 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 20/11/2024 10:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : For further details please see the documents of the Call for tenders.
A non-disclosure agreement is required : yes
Additional information about the non-disclosure agreement : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
Organisation providing additional information about the procurement procedure : Finnish Institute for Health and Welfare
Organisation receiving requests to participate : Finnish Institute for Health and Welfare
Organisation processing tenders : Finnish Institute for Health and Welfare
TED eSender : Hansel Oy (Hilma)

5.1 Lot technical ID : LOT-0006

Title : LOT 6: Claritromycin 250 mg (tablet/capsule, oral, ATC J01FA09)
Description : The subject of the procurement is Article in accordance with the following requirements: - The subject of tender: Claritromycin 250 mg (tablet/capsule, oral, ATC J01FA09) - Oral solid dosage forms - Active pharmaceutical ingredient: Claritromycin - Strength: 250 mg - Pharmaceutical form: Tablet/capsule The minimum requirements of the Article is described in more detail in Annex 1.1. The delivery schedule for the articles is described in Annex 1. Quantity for the Article is described in Annex 7 (restricted, TL IV). In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer. The Contract will be awarded to one Supplier based on a comparison of tenders. Tender that is economically the most advantageous will win the competition.
Internal identifier : 6

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651100 Antibacterials for systemic use
Options :
Description of the options : In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer.

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Duration : 13 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : Union Civil Protection Mechanism (rescEU) (2021/2027)
Identifier of EU funds : rescEU-MED-CBRN-FI
Further details of EU funds : rescEU - Medical Stockpiling in Finland
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : The tenderer´s financial prerequisites are sufficient with regard to the size and nature of the procurement. In order that the tenderer may be estimated to be able to provide and deliver the Articles subject to procurement, the Customer requires that the tenderer´s turnover each of the two (2) previous accounting years (2022 and 2023) have been at least one million euros (1 000 000 EUR).
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a trade register
Description : It is enrolled in the relevant trade registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability

5.1.10 Award criteria

Criterion :
Type : Price
Name : Reference price
Description : The reference price of the tender consists of the price of one (1) unit of the Article (exclusive of VAT). The offered price includes the Articles and transport according to the Call for tenders and covers all requirements set out in the Call for tenders and it's Annexes. There shall be no additional costs for the THL. The lowest reference price will get maximum price score. Other tenderers will get price score according to the following price score calculation formula: the lowest reference price / tendered reference price * maximum price score (50).
Weight (points, exact) : 50
Criterion :
Type : Quality
Name : Quality 1: Registered shelf life of the Article
Description : The offered Article has as long as possible registered shelf life. A shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 2: Delivery time to the Customer’s warehouse
Description : 50 % of the total quantity should be delivered as soon as possible. The faster the tenderer can deliver 50 % of the total quantity, the more points it will receive according to the menus in the Call for tenders. A maximum of 15 points can be achieved.
Weight (points, exact) : 15
Criterion :
Type : Quality
Name : Quality 3: Transportation temperature and excursions
Description : If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the tenderer receives 3 points. The tenderer shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.
Weight (points, exact) : 3
Criterion :
Type : Quality
Name : Quality 4: Marketing authorisation valid in Finland and Finnish language of packaging
Description : If the Article offered has marketing authorisation valid in Finland (national or EMA centralized EU Marketing Authorisation) and Finnish language packaging material inspected and reviewed by the competent authority, the supplier receives 10 points.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 5: Rotation plan for the Article
Description : Tenderer has a possibility to achieve a maximum of 12 quality points by submitting a rotation plan to avoid unnecessary disposal of medicinal products in accordance with the Annex 2. The rotation plan shall fulfill the requirements set out in the annex 2. A panel of THL experts will evaluate the tenderer's rotation plan according to the scoring table described in the Annex 2.1. The tenderer will receive quality points according to the following formula: Expert panel score / 5 (number of scoring criteria).
Weight (points, exact) : 12
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Access to certain procurement documents is restricted
Justification for restricting access to certain procurement documents : Protection of particularly sensitive information
Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 06/11/2024 10:00 +00:00
Information about restricted documents is available at : https://tarjouspalvelu.fi/thl?id=530415&tpk=e761e1cb-3b59-453c-b575-a799b1e76a09

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 20/11/2024 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 20/11/2024 10:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : For further details please see the documents of the Call for tenders.
A non-disclosure agreement is required : yes
Additional information about the non-disclosure agreement : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
Organisation providing additional information about the procurement procedure : Finnish Institute for Health and Welfare
Organisation receiving requests to participate : Finnish Institute for Health and Welfare
Organisation processing tenders : Finnish Institute for Health and Welfare
TED eSender : Hansel Oy (Hilma)

5.1 Lot technical ID : LOT-0007

Title : LOT 7: Clindamycin 15 mg/ml (80 ml, oral suspension, ATC J01FF01)
Description : The subject of the procurement is Article in accordance with the following requirements: - The subject of tender: Clindamycin 15 mg/ml (80 ml, oral suspension, ATC J01FF01) - Oral liquid dosage forms - Active pharmaceutical ingredient: Clindamycin - Strength: 15 mg/ml - Pharmaceutical form: 80 ml oral suspension The minimum requirements of the Article is described in more detail in Annex 1.1. The delivery schedule for the articles is described in Annex 1. Quantity for the Article is described in Annex 7 (restricted, TL IV). In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer. The Contract will be awarded to one Supplier based on a comparison of tenders. Tender that is economically the most advantageous will win the competition.
Internal identifier : 7

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651100 Antibacterials for systemic use
Options :
Description of the options : In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer.

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Duration : 13 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : Union Civil Protection Mechanism (rescEU) (2021/2027)
Identifier of EU funds : rescEU-MED-CBRN-FI
Further details of EU funds : rescEU - Medical Stockpiling in Finland
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : The tenderer´s financial prerequisites are sufficient with regard to the size and nature of the procurement. In order that the tenderer may be estimated to be able to provide and deliver the Articles subject to procurement, the Customer requires that the tenderer´s turnover each of the two (2) previous accounting years (2022 and 2023) have been at least one million euros (1 000 000 EUR).
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a trade register
Description : It is enrolled in the relevant trade registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability

5.1.10 Award criteria

Criterion :
Type : Price
Name : Reference price
Description : The reference price of the tender consists of the price of one (1) unit of the Article (exclusive of VAT). The offered price includes the Articles and transport according to the Call for tenders and covers all requirements set out in the Call for tenders and it's Annexes. There shall be no additional costs for the THL. The lowest reference price will get maximum price score. Other tenderers will get price score according to the following price score calculation formula: the lowest reference price / tendered reference price * maximum price score (50).
Weight (points, exact) : 50
Criterion :
Type : Quality
Name : Quality 1: Registered shelf life of the Article
Description : The offered Article has as long as possible registered shelf life. A shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 2: Delivery time to the Customer’s warehouse
Description : 50 % of the total quantity should be delivered as soon as possible. The faster the tenderer can deliver 50 % of the total quantity, the more points it will receive according to the menus in the Call for tenders. A maximum of 15 points can be achieved.
Weight (points, exact) : 15
Criterion :
Type : Quality
Name : Quality 3: Transportation temperature and excursions
Description : If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the tenderer receives 3 points. The tenderer shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.
Weight (points, exact) : 3
Criterion :
Type : Quality
Name : Quality 4: Marketing authorisation valid in Finland and Finnish language of packaging
Description : If the Article offered has marketing authorisation valid in Finland (national or EMA centralized EU Marketing Authorisation) and Finnish language packaging material inspected and reviewed by the competent authority, the supplier receives 10 points.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 5: Rotation plan for the Article
Description : Tenderer has a possibility to achieve a maximum of 12 quality points by submitting a rotation plan to avoid unnecessary disposal of medicinal products in accordance with the Annex 2. The rotation plan shall fulfill the requirements set out in the annex 2. A panel of THL experts will evaluate the tenderer's rotation plan according to the scoring table described in the Annex 2.1. The tenderer will receive quality points according to the following formula: Expert panel score / 5 (number of scoring criteria).
Weight (points, exact) : 12
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Access to certain procurement documents is restricted
Justification for restricting access to certain procurement documents : Protection of particularly sensitive information
Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 06/11/2024 10:00 +00:00
Information about restricted documents is available at : https://tarjouspalvelu.fi/thl?id=530415&tpk=e761e1cb-3b59-453c-b575-a799b1e76a09

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 20/11/2024 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 20/11/2024 10:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : For further details please see the documents of the Call for tenders.
A non-disclosure agreement is required : yes
Additional information about the non-disclosure agreement : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
Organisation providing additional information about the procurement procedure : Finnish Institute for Health and Welfare
Organisation receiving requests to participate : Finnish Institute for Health and Welfare
Organisation processing tenders : Finnish Institute for Health and Welfare
TED eSender : Hansel Oy (Hilma)

5.1 Lot technical ID : LOT-0008

Title : LOT 9: Levofloxacin 500 mg (tablet/capsule, oral, ATC J01MA12)
Description : The subject of the procurement is Article in accordance with the following requirements: - The subject of tender: Levofloxacin 500 mg (tablet/capsule, oral, ATC J01MA12) - Oral solid dosage forms - Active pharmaceutical ingredient: Levofloxacin - Strength: 500 mg - Pharmaceutical form: Tablet/capsule The minimum requirements of the Article is described in more detail in Annex 1.1. The delivery schedule for the articles is described in Annex 1. Quantity for the Article is described in Annex 7 (restricted, TL IV). In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer. The Contract will be awarded to one Supplier based on a comparison of tenders. Tender that is economically the most advantageous will win the competition.
Internal identifier : 9

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651100 Antibacterials for systemic use
Options :
Description of the options : In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer.

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Duration : 13 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : Union Civil Protection Mechanism (rescEU) (2021/2027)
Identifier of EU funds : rescEU-MED-CBRN-FI
Further details of EU funds : rescEU - Medical Stockpiling in Finland
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : The tenderer´s financial prerequisites are sufficient with regard to the size and nature of the procurement. In order that the tenderer may be estimated to be able to provide and deliver the Articles subject to procurement, the Customer requires that the tenderer´s turnover each of the two (2) previous accounting years (2022 and 2023) have been at least one million euros (1 000 000 EUR).
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a trade register
Description : It is enrolled in the relevant trade registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability

5.1.10 Award criteria

Criterion :
Type : Price
Name : Reference price
Description : The reference price of the tender consists of the price of one (1) unit of the Article (exclusive of VAT). The offered price includes the Articles and transport according to the Call for tenders and covers all requirements set out in the Call for tenders and it's Annexes. There shall be no additional costs for the THL. The lowest reference price will get maximum price score. Other tenderers will get price score according to the following price score calculation formula: the lowest reference price / tendered reference price * maximum price score (50).
Weight (points, exact) : 50
Criterion :
Type : Quality
Name : Quality 1: Registered shelf life of the Article
Description : The offered Article has as long as possible registered shelf life. A shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 2: Delivery time to the Customer’s warehouse
Description : 50 % of the total quantity should be delivered as soon as possible. The faster the tenderer can deliver 50 % of the total quantity, the more points it will receive according to the menus in the Call for tenders. A maximum of 15 points can be achieved.
Weight (points, exact) : 15
Criterion :
Type : Quality
Name : Quality 3: Transportation temperature and excursions
Description : If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the tenderer receives 3 points. The tenderer shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.
Weight (points, exact) : 3
Criterion :
Type : Quality
Name : Quality 4: Marketing authorisation valid in Finland and Finnish language of packaging
Description : If the Article offered has marketing authorisation valid in Finland (national or EMA centralized EU Marketing Authorisation) and Finnish language packaging material inspected and reviewed by the competent authority, the supplier receives 10 points.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 5: Rotation plan for the Article
Description : Tenderer has a possibility to achieve a maximum of 12 quality points by submitting a rotation plan to avoid unnecessary disposal of medicinal products in accordance with the Annex 2. The rotation plan shall fulfill the requirements set out in the annex 2. A panel of THL experts will evaluate the tenderer's rotation plan according to the scoring table described in the Annex 2.1. The tenderer will receive quality points according to the following formula: Expert panel score / 5 (number of scoring criteria).
Weight (points, exact) : 12
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Access to certain procurement documents is restricted
Justification for restricting access to certain procurement documents : Protection of particularly sensitive information
Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 06/11/2024 10:00 +00:00
Information about restricted documents is available at : https://tarjouspalvelu.fi/thl?id=530415&tpk=e761e1cb-3b59-453c-b575-a799b1e76a09

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 20/11/2024 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 20/11/2024 10:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : For further details please see the documents of the Call for tenders.
A non-disclosure agreement is required : yes
Additional information about the non-disclosure agreement : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
Organisation providing additional information about the procurement procedure : Finnish Institute for Health and Welfare
Organisation receiving requests to participate : Finnish Institute for Health and Welfare
Organisation processing tenders : Finnish Institute for Health and Welfare
TED eSender : Hansel Oy (Hilma)

5.1 Lot technical ID : LOT-0009

Title : LOT 8: Moxifloxacin 400 mg (tablet/capsule, oral, ATC J01MA14)
Description : The subject of the procurement is Article in accordance with the following requirements: - The subject of tender: Moxifloxacin 400 mg (tablet/capsule, oral, ATC J01MA14) - Oral solid dosage forms - Active pharmaceutical ingredient: Moxifloxacin - Strength: 400 mg - Pharmaceutical form: Tablet/capsule The minimum requirements of the Article is described in more detail in Annex 1.1. The delivery schedule for the articles is described in Annex 1. Quantity for the Article is described in Annex 7 (restricted, TL IV). In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer. The Contract will be awarded to one Supplier based on a comparison of tenders. Tender that is economically the most advantageous will win the competition.
Internal identifier : 8

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651100 Antibacterials for systemic use
Options :
Description of the options : In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer.

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Duration : 13 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : Union Civil Protection Mechanism (rescEU) (2021/2027)
Identifier of EU funds : rescEU-MED-CBRN-FI
Further details of EU funds : rescEU - Medical Stockpiling in Finland
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : The tenderer´s financial prerequisites are sufficient with regard to the size and nature of the procurement. In order that the tenderer may be estimated to be able to provide and deliver the Articles subject to procurement, the Customer requires that the tenderer´s turnover each of the two (2) previous accounting years (2022 and 2023) have been at least one million euros (1 000 000 EUR).
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a trade register
Description : It is enrolled in the relevant trade registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability

5.1.10 Award criteria

Criterion :
Type : Price
Name : Reference price
Description : The reference price of the tender consists of the price of one (1) unit of the Article (exclusive of VAT). The offered price includes the Articles and transport according to the Call for tenders and covers all requirements set out in the Call for tenders and it's Annexes. There shall be no additional costs for the THL. The lowest reference price will get maximum price score. Other tenderers will get price score according to the following price score calculation formula: the lowest reference price / tendered reference price * maximum price score (50).
Weight (points, exact) : 50
Criterion :
Type : Quality
Name : Quality 1: Registered shelf life of the Article
Description : The offered Article has as long as possible registered shelf life. A shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 2: Delivery time to the Customer’s warehouse
Description : 50 % of the total quantity should be delivered as soon as possible. The faster the tenderer can deliver 50 % of the total quantity, the more points it will receive according to the menus in the Call for tenders. A maximum of 15 points can be achieved.
Weight (points, exact) : 15
Criterion :
Type : Quality
Name : Quality 3: Transportation temperature and excursions
Description : If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the tenderer receives 3 points. The tenderer shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.
Weight (points, exact) : 3
Criterion :
Type : Quality
Name : Quality 4: Marketing authorisation valid in Finland and Finnish language of packaging
Description : If the Article offered has marketing authorisation valid in Finland (national or EMA centralized EU Marketing Authorisation) and Finnish language packaging material inspected and reviewed by the competent authority, the supplier receives 10 points.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 5: Rotation plan for the Article
Description : Tenderer has a possibility to achieve a maximum of 12 quality points by submitting a rotation plan to avoid unnecessary disposal of medicinal products in accordance with the Annex 2. The rotation plan shall fulfill the requirements set out in the annex 2. A panel of THL experts will evaluate the tenderer's rotation plan according to the scoring table described in the Annex 2.1. The tenderer will receive quality points according to the following formula: Expert panel score / 5 (number of scoring criteria).
Weight (points, exact) : 12
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Access to certain procurement documents is restricted
Justification for restricting access to certain procurement documents : Protection of particularly sensitive information
Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 06/11/2024 10:00 +00:00
Information about restricted documents is available at : https://tarjouspalvelu.fi/thl?id=530415&tpk=e761e1cb-3b59-453c-b575-a799b1e76a09

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 20/11/2024 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 20/11/2024 10:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : For further details please see the documents of the Call for tenders.
A non-disclosure agreement is required : yes
Additional information about the non-disclosure agreement : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
Organisation providing additional information about the procurement procedure : Finnish Institute for Health and Welfare
Organisation receiving requests to participate : Finnish Institute for Health and Welfare
Organisation processing tenders : Finnish Institute for Health and Welfare
TED eSender : Hansel Oy (Hilma)

5.1 Lot technical ID : LOT-0010

Title : LOT 10: Claritromycin oral suspension 50 mg/ml (50 ml, oral suspension ATC J01FA09)
Description : The subject of the procurement is Article in accordance with the following requirements: - The subject of tender: Claritromycin oral suspension 50 mg/ml (50 ml, oral suspension ATC J01FA09) - Oral liquid dosage forms - Active pharmaceutical ingredient: Claritromycin - Strength: 50 mg/ml - Pharmaceutical form: 50 ml oral suspension The minimum requirements of the Article is described in more detail in Annex 1.1. The delivery schedule for the articles is described in Annex 1. Quantity for the Article is described in Annex 7 (restricted, TL IV). In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer. The Contract will be awarded to one Supplier based on a comparison of tenders. Tender that is economically the most advantageous will win the competition.
Internal identifier : 10

5.1.1 Purpose

Main nature of the contract : Supplies
Main classification ( cpv ): 33651100 Antibacterials for systemic use
Options :
Description of the options : In addition to the quantity of the Articles indicated in the Annex 7, the Customer shall be entitled to purchase 100 % extra to the original quantities (later referred as "Option") described in the Annex 7. The decision to exercise the Option is in the Customer´s sole discretion. Customer should exercise the Option in part or in whole. The Customer shall notify the Supplier at the latest by the end of June 2026 if it wishes to take on the Option. The delivery schedule for the Option shall be agreed separately between the Contracting Parties. Nevertheless, the Supplier shall not be obliged to agree to deliver the Option to the Customer.

5.1.2 Place of performance

Country : Finland
Anywhere in the given country
Additional information :

5.1.3 Estimated duration

Duration : 13 Month

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : Union Civil Protection Mechanism (rescEU) (2021/2027)
Identifier of EU funds : rescEU-MED-CBRN-FI
Further details of EU funds : rescEU - Medical Stockpiling in Finland
The procurement is covered by the Government Procurement Agreement (GPA) : yes
This procurement is also suitable for small and medium-sized enterprises (SMEs)

5.1.9 Selection criteria

Criterion :
Type : Economic and financial standing
Name : Yearly turnover
Description : The tenderer´s financial prerequisites are sufficient with regard to the size and nature of the procurement. In order that the tenderer may be estimated to be able to provide and deliver the Articles subject to procurement, the Customer requires that the tenderer´s turnover each of the two (2) previous accounting years (2022 and 2023) have been at least one million euros (1 000 000 EUR).
Criterion :
Type : Suitability to pursue the professional activity
Name : Enrolment in a trade register
Description : It is enrolled in the relevant trade registers kept in the Member State of its establishment.
Criterion :
Type : Technical and professional ability

5.1.10 Award criteria

Criterion :
Type : Price
Name : Reference price
Description : The reference price of the tender consists of the price of one (1) unit of the Article (exclusive of VAT). The offered price includes the Articles and transport according to the Call for tenders and covers all requirements set out in the Call for tenders and it's Annexes. There shall be no additional costs for the THL. The lowest reference price will get maximum price score. Other tenderers will get price score according to the following price score calculation formula: the lowest reference price / tendered reference price * maximum price score (50).
Weight (points, exact) : 50
Criterion :
Type : Quality
Name : Quality 1: Registered shelf life of the Article
Description : The offered Article has as long as possible registered shelf life. A shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 2: Delivery time to the Customer’s warehouse
Description : 50 % of the total quantity should be delivered as soon as possible. The faster the tenderer can deliver 50 % of the total quantity, the more points it will receive according to the menus in the Call for tenders. A maximum of 15 points can be achieved.
Weight (points, exact) : 15
Criterion :
Type : Quality
Name : Quality 3: Transportation temperature and excursions
Description : If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the tenderer receives 3 points. The tenderer shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.
Weight (points, exact) : 3
Criterion :
Type : Quality
Name : Quality 4: Marketing authorisation valid in Finland and Finnish language of packaging
Description : If the Article offered has marketing authorisation valid in Finland (national or EMA centralized EU Marketing Authorisation) and Finnish language packaging material inspected and reviewed by the competent authority, the supplier receives 10 points.
Weight (points, exact) : 10
Criterion :
Type : Quality
Name : Quality 5: Rotation plan for the Article
Description : Tenderer has a possibility to achieve a maximum of 12 quality points by submitting a rotation plan to avoid unnecessary disposal of medicinal products in accordance with the Annex 2. The rotation plan shall fulfill the requirements set out in the annex 2. A panel of THL experts will evaluate the tenderer's rotation plan according to the scoring table described in the Annex 2.1. The tenderer will receive quality points according to the following formula: Expert panel score / 5 (number of scoring criteria).
Weight (points, exact) : 12
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

Access to certain procurement documents is restricted
Justification for restricting access to certain procurement documents : Protection of particularly sensitive information
Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 06/11/2024 10:00 +00:00
Information about restricted documents is available at : https://tarjouspalvelu.fi/thl?id=530415&tpk=e761e1cb-3b59-453c-b575-a799b1e76a09

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Not allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of tenders : 20/11/2024 10:00 +00:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 20/11/2024 10:30 +00:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : For further details please see the documents of the Call for tenders.
A non-disclosure agreement is required : yes
Additional information about the non-disclosure agreement : The availability for the Annex 7 is restricted to security classification level IV (TL IV). THL will send the Annex 7 to a representative of the tenderer via encrypted email after THL has received a scanned version of the signed Confidentiality commitment (Annex 6). The signature of the Confidentiality commitment shall be done manually by hand. Confidentiality commitment shall be signed by a legal representative of tenderer. Confidentiality commitment shall be sent to the email address kirjaamo@thl.fi with the subject line "CONFIDENTIALITY COMMITMENT - THL/5372/2.02.06/2024 / Antibacterial and antimycobacterial products for systemic use". The message shall contain name of the tenderer and email address to which the Annex 7 is to be sent.
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Markkinaoikeus
Organisation providing additional information about the procurement procedure : Finnish Institute for Health and Welfare
Organisation receiving requests to participate : Finnish Institute for Health and Welfare
Organisation processing tenders : Finnish Institute for Health and Welfare
TED eSender : Hansel Oy (Hilma)

8. Organisations

8.1 ORG-0001

Official name : Markkinaoikeus
Registration number : 3006157-6
Postal address : Radanrakentajantie 5
Town : Helsinki
Postcode : 00520
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Telephone : +358 295643300
Roles of this organisation :
Review organisation

8.1 ORG-0002

Official name : Finnish Institute for Health and Welfare
Registration number : 2229500-6
Postal address : P. O. BOX 30
Town : Helsinki
Postcode : 00271
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Contact point : Procurement services / Keskitetty hankintatoimi
Telephone : +358 295246000
Roles of this organisation :
Buyer
Organisation providing additional information about the procurement procedure
Organisation receiving requests to participate
Organisation processing tenders

8.1 ORG-0003

Official name : Hansel Oy (Hilma)
Registration number : FI09880841
Postal address : Mannerheiminaukio 1a
Town : Helsinki
Postcode : 00100
Country subdivision (NUTS) : Helsinki-Uusimaa ( FI1B1 )
Country : Finland
Contact point : eSender
Telephone : 029 55 636 30
Roles of this organisation :
TED eSender

11. Notice information

11.1 Notice information

Notice identifier/version : 670402ac-e154-439e-b95a-a9e9a17df2d3 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 17/10/2024 10:14 +00:00
Notice dispatch date (eSender) : 17/10/2024 12:03 +00:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00631175-2024
OJ S issue number : 204/2024
Publication date : 18/10/2024