The Scope of the procurement is Antidotes and poisoning medical products (part 2) to the rescEU project. The Scope of procurement is described in more detail in Annex 1.
The procurement is divided in nine (9) lots. Tender may be submitted for one or several lots.
- LOT 1: Naloxone 1 mg/ml (2 ml per pre-filled syringe, ATC V03AB15)
- LOT 2: Naloxone 0,4 mg/ml (1 ml per vial/ampoule, ATC V03AB15)
- LOT 3: Sodiumthiosulfate 25 % (100 ml per vial/ampule, ATC V03AB06)
- LOT 4: Physostigmine 2 mg/5 ml (5 ml per vial/ampoule, ATC V03AB19)
- LOT 5: Ethanol 95 – 96 % / 20 ml (20 ml per vial/ampoule, ATC V03AB16)
- LOT 6: Silibinin (350 mg powder for i.v. / vial, ATC V03AX)
- LOT 7: Atropine sulphate 10 mg/ml (10 ml per vial/ampoule, ATC A03BA01)
- LOT 8: Pegfilgrastim 6 mg/0,6 ml (0,6 ml per vial/ampoule/prefilled syringe, ATC L03AA13)
- LOT 9: Naloxone / single dose container (no further device assembly is required, ATC V03AB15)
All products are for CBRN poisoning treatment or CBRN antidotes.
The minimum requirements for the articles 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.
Estimated quantity for the product in described in Annex 6 (restricted to security classification level IV, TL IV). In addition to the estimated quantity indicated in the Annex 6, the Customer is entitled to purchase 100 % extra to the estimated quantities (later referred as "Option"). The Supplier is not obliged to deliver the Articles 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 Contract
Annex 3 Security annex
Annex 4 Description of the Handi service
Annex 5 JYSE 2014 SUPPLIES (updated version of April 2022)
Annex 6 Estimated quantity (restricted, TL IV)
Annex 7 Confidentiality commitment
Please note that the numbering of the annexes differs between the Contract and the Call for Tenders.
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Lot nr.: 1
LOT 1: Naloxone 1 mg/ml (2 ml per pre-filled syringe, ATC V03AB15)
The subject of the procurement is article in accordance with the following requirements:
- The subject of tender: Naloxone 1 mg/ml (2 ml per pre-filled syringe, ATC V03AB15)
- Parenteral products (intramuscular administration) for CBRN poisoning treatment or CBRN antidotes
- Active pharmaceutical ingredient: Naloxone
- Strength: 1 mg/ml
- Pharmaceutical form: pre-filled syringe
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.
Estimated quantity for the article is described in Annex 6 (restricted, TL IV). In addition to the estimated quantity indicated in the Annex 6, the Customer is entitled to purchase 100 % extra to the estimated quantities (later referred as "Option"). The Customer can use as much of the option as it needs. The Customer shall notify the Supplier by the end of June 2026 at the latest, if it wishes to exercise the Option. The delivery schedule for the Option will be agreed separately between the Contracting parties. The Supplier is not obliged to deliver the Articles under the Option.
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.
Type of contract: Supplies
Authority: Finnish Institute for Health and Welfare
Information URL:
https://thl.fi/en/web/thlfi-en
Duration contract months: 17
Criteria definitions: Price: (The reference price of the tender consist of the price of one (1) prefilled syringe. The offered price includes the article and transport according to the call for tenders and covers all requirements set out in the Call for Tenders and it's Annexes.)
Quality: (The offered article has as long as possible registered shelf life. Shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point. A maximum of 10 points can be achieved.)
Quality: (50 % of the total quantity should be delivered as soon as possible. The tenderer receives points for increasing the capacity according to the menus in the Call for Tenders. A maximum of 40 points can be achieved.)
Quality: (The tenderer who is able to and will deliver English language packages with English language product information leaflets receives 15 points. To be eligible to receive the points, the English language leaflet should have been inspected and reviewed by National Competent Authority (NCA) or European Medicine Authority (EMA).)
Quality: (If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the supplier receives 10 points. The supplier shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.)
Quality: (If the product has an EMA centralized EU Marketing Authorisation, the supplier receives 25 points.)
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Lot nr.: 2
LOT 2: Naloxone 0,4 mg/ml (1 ml per vial/ampoule, ATC V03AB15)
The subject of the procurement is article in accordance with the following requirements:
- The subject of tender: Naloxone 0,4 mg/ml (1 ml per vial/ampoule, ATC V03AB15)
- Parenteral products (intravenous administration) for CBRN poisoning treatment or CBRN antidotes
- Active pharmaceutical ingredient: Naloxone
- Strength: 0,4 mg/ml
- Pharmaceutical form: vial/ampoule
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.
Estimated quantity for the article is described in Annex 6 (restricted, TL IV). In addition to the estimated quantity indicated in the Annex 6, the Customer is entitled to purchase 100 % extra to the estimated quantities (later referred as "Option"). The Customer can use as much of the option as it needs. The Customer shall notify the Supplier by the end of June 2026 at the latest, if it wishes to exercise the Option. The delivery schedule for the Option will be agreed separately between the Contracting parties. The Supplier is not obliged to deliver the Articles under the Option.
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.
Type of contract: Supplies
Authority: Finnish Institute for Health and Welfare
Information URL:
https://thl.fi/en/web/thlfi-en
Duration contract months: 17
Criteria definitions: Price: (The reference price of the tender consist of the price of one (1) vial/ampule. The offered price includes the article and transport according to the call for tenders and covers all requirements set out in the Call for Tenders and it's Annexes.)
Quality: (The offered article has as long as possible registered shelf life. Shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point. A maximum of 10 points can be achieved.)
Quality: (50 % of the total quantity should be delivered as soon as possible. The tenderer receives points for increasing the capacity according to the menus in the Call for Tenders. A maximum of 40 points can be achieved.)
Quality: (The tenderer who is able to and will deliver English language packages with English language product information leaflets receives 15 points. To be eligible to receive the points, the English language leaflet should have been inspected and reviewed by National Competent Authority (NCA) or European Medicine Authority (EMA).)
Quality: (If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the supplier receives 10 points. The supplier shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.)
Quality: (If the product has an EMA centralized EU Marketing Authorisation, the supplier receives 25 points.)
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Lot nr.: 3
LOT 3: Sodiumthiosulfate 25 % / 100 ml (100 ml per vial/ampule, ATC V03AB06)
The subject of the procurement is article in accordance with the following requirements:
- The subject of tender: Sodiumthiosulfate 25 % (100 ml per vial/ampule, ATC V03AB06)
- Parenteral products (intravenous administration) for CBRN poisoning treatment or CBRN antidotes
- Active pharmaceutical ingredient: Sodiumthiosulfate
- Strength: 25 % / 100 ml
- Pharmaceutical form: vial/ampule
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.
Estimated quantity for the article is described in Annex 6 (restricted, TL IV). In addition to the estimated quantity indicated in the Annex 6, the Customer is entitled to purchase 100 % extra to the estimated quantities (later referred as "Option"). The Customer can use as much of the option as it needs. The Customer shall notify the Supplier by the end of June 2026 at the latest, if it wishes to exercise the Option. The delivery schedule for the Option will be agreed separately between the Contracting parties. The Supplier is not obliged to deliver the Articles under the Option.
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.
Type of contract: Supplies
Authority: Finnish Institute for Health and Welfare
Information URL:
https://thl.fi/en/web/thlfi-en
Duration contract months: 17
Criteria definitions: Price: (The reference price of the tender consist of the price of one (1) vial/ampule. The offered price includes the article and transport according to the call for tenders and covers all requirements set out in the Call for Tenders and it's Annexes.)
Quality: (The offered article has as long as possible registered shelf life. Shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point. A maximum of 10 points can be achieved.)
Quality: (50 % of the total quantity should be delivered as soon as possible. The tenderer receives points for increasing the capacity according to the menus in the Call for Tenders. A maximum of 40 points can be achieved.)
Quality: (The tenderer who is able to and will deliver English language packages with English language product information leaflets receives 15 points. To be eligible to receive the points, the English language leaflet should have been inspected and reviewed by National Competent Authority (NCA) or European Medicine Authority (EMA).)
Quality: (If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the supplier receives 10 points. The supplier shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.)
Quality: (If the product has an EMA centralized EU Marketing Authorisation, the supplier receives 25 points.)
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Lot nr.: 4
LOT 4: Physostigmine 2 mg / 5 ml (5 ml per vial/ampoule, ATC V03AB19)
The subject of the procurement is article in accordance with the following requirements:
- The subject of tender: Physostigmine 2 mg / 5 ml (5 ml per vial/ampoule, ATC V03AB19)
- Parenteral products (intravenous administration) for CBRN poisoning treatment or CBRN antidotes
- Active pharmaceutical ingredient: Physostigmine
- Strength: 2 mg / 5 ml
- Pharmaceutical form: vial/ampoule
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.
Estimated quantity for the article is described in Annex 6 (restricted, TL IV). In addition to the estimated quantity indicated in the Annex 6, the Customer is entitled to purchase 100 % extra to the estimated quantities (later referred as "Option"). The Customer can use as much of the option as it needs. The Customer shall notify the Supplier by the end of June 2026 at the latest, if it wishes to exercise the Option. The delivery schedule for the Option will be agreed separately between the Contracting parties. The Supplier is not obliged to deliver the Articles under the Option.
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.
Type of contract: Supplies
Authority: Finnish Institute for Health and Welfare
Information URL:
https://thl.fi/en/web/thlfi-en
Duration contract months: 17
Criteria definitions: Price: (The reference price of the tender consist of the price of one (1) vial/ampoule. The offered price includes the article and transport according to the call for tenders and covers all requirements set out in the Call for Tenders and it's Annexes.)
Quality: (The offered article has as long as possible registered shelf life. Shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point. A maximum of 10 points can be achieved.)
Quality: (50 % of the total quantity should be delivered as soon as possible. The tenderer receives points for increasing the capacity according to the menus in the Call for Tenders. A maximum of 40 points can be achieved.)
Quality: (he tenderer who is able to and will deliver English language packages with English language product information leaflets receives 15 points. To be eligible to receive the points, the English language leaflet should have been inspected and reviewed by National Competent Authority (NCA) or European Medicine Authority (EMA).)
Quality: (If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the supplier receives 10 points. The supplier shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.)
Quality: (If the product has an EMA centralized EU Marketing Authorisation, the supplier receives 25 points.)
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Lot nr.: 5
LOT 5: Ethanol 95 – 96 % / 20 ml (20 ml per vial/ampoule, ATC V03AB16)
The subject of the procurement is article in accordance with the following requirements:
- The subject of tender: Ethanol 95 – 96 % / 20 ml (20 ml per vial/ampoule, ATC V03AB16)
- Parenteral products (intravenous administration) for CBRN poisoning treatment or CBRN antidotes
- Active pharmaceutical ingredient: Ethanol
- Strength: 95 – 96 % / 20 ml
- Pharmaceutical form: vial/ampoule
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.
Estimated quantity for the article is described in Annex 6 (restricted, TL IV). In addition to the estimated quantity indicated in the Annex 6, the Customer is entitled to purchase 100 % extra to the estimated quantities (later referred as "Option"). The Customer can use as much of the option as it needs. The Customer shall notify the Supplier by the end of June 2026 at the latest, if it wishes to exercise the Option. The delivery schedule for the Option will be agreed separately between the Contracting parties. The Supplier is not obliged to deliver the Articles under the Option.
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.
Type of contract: Supplies
Authority: Finnish Institute for Health and Welfare
Information URL:
https://thl.fi/en/web/thlfi-en
Duration contract months: 17
Criteria definitions: Price: (The reference price of the tender consist of the price of one (1) vial/ampoule. The offered price includes the article and transport according to the call for tenders and covers all requirements set out in the Call for Tenders and it's Annexes.)
Quality: (The offered article has as long as possible registered shelf life. Shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point. A maximum of 10 points can be achieved.)
Quality: (50 % of the total quantity should be delivered as soon as possible. The tenderer receives points for increasing the capacity according to the menus in the Call for Tenders. A maximum of 40 points can be achieved.)
Quality: (The tenderer who is able to and will deliver English language packages with English language product information leaflets receives 15 points. To be eligible to receive the points, the English language leaflet should have been inspected and reviewed by National Competent Authority (NCA) or European Medicine Authority (EMA).)
Quality: (If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the supplier receives 10 points. The supplier shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.)
Quality: (If the product has an EMA centralized EU Marketing Authorisation, the supplier receives 25 points.)
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Lot nr.: 6
LOT 6: Silibinin (350 mg powder for i.v. / vial, ATC V03AX)
The subject of the procurement is article in accordance with the following requirements:
- The subject of tender: Silibinin (350 mg powder for i.v. / vial, ATC V03AX)
- Parenteral products (intravenous administration) for CBRN poisoning treatment or CBRN antidotes
- Active pharmaceutical ingredient: Silibinin
- Pharmaceutical form: powder for i.v. / vial
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.
Estimated quantity for the article is described in Annex 6 (restricted, TL IV). In addition to the estimated quantity indicated in the Annex 6, the Customer is entitled to purchase 100 % extra to the estimated quantities (later referred as "Option"). The Customer can use as much of the option as it needs. The Customer shall notify the Supplier by the end of June 2026 at the latest, if it wishes to exercise the Option. The delivery schedule for the Option will be agreed separately between the Contracting parties. The Supplier is not obliged to deliver the Articles under the Option.
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.
Type of contract: Supplies
Authority: Finnish Institute for Health and Welfare
Information URL:
https://thl.fi/en/web/thlfi-en
Duration contract months: 17
Criteria definitions: Price: (The reference price of the tender consist of the price of one (1) 350 mg powder for i.v. / vial. The offered price includes the article and transport according to the call for tenders and covers all requirements set out in the Call for Tenders and it's Annexes.)
Quality: (The offered article has as long as possible registered shelf life. Shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point. A maximum of 10 points can be achieved.)
Quality: (50 % of the total quantity should be delivered as soon as possible. The tenderer receives points for increasing the capacity according to the menus in the Call for Tenders. A maximum of 40 points can be achieved.)
Quality: (The tenderer who is able to and will deliver English language packages with English language product information leaflets receives 15 points. To be eligible to receive the points, the English language leaflet should have been inspected and reviewed by National Competent Authority (NCA) or European Medicine Authority (EMA).)
Quality: (If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the supplier receives 10 points. The supplier shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.)
Quality: (If the product has an EMA centralized EU Marketing Authorisation, the supplier receives 25 points.)
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Lot nr.: 7
LOT 7: Atropine sulphate 10 mg/ml (10 ml per vial/ampoule, ATC A03BA01)
The subject of the procurement is article in accordance with the following requirements:
- The subject of tender: Atropine sulphate 10 mg/ml (10 ml per vial/ampoule, ATC A03BA01)
- Parenteral products (intravenous administration) for CBRN poisoning treatment or CBRN antidotes
- Active pharmaceutical ingredient: Atropine sulphate
- Strength: 10 mg/ml
- Pharmaceutical form: vial/ampoule
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.
Estimated quantity for the article is described in Annex 6 (restricted, TL IV). In addition to the estimated quantity indicated in the Annex 6, the Customer is entitled to purchase 100 % extra to the estimated quantities (later referred as "Option"). The Customer can use as much of the option as it needs. The Customer shall notify the Supplier by the end of June 2026 at the latest, if it wishes to exercise the Option. The delivery schedule for the Option will be agreed separately between the Contracting parties. The Supplier is not obliged to deliver the Articles under the Option.
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.
Type of contract: Supplies
Authority: Finnish Institute for Health and Welfare
Information URL:
https://thl.fi/en/web/thlfi-en
Duration contract months: 17
Criteria definitions: Price: (The reference price of the tender consist of the price of one (1) vial/ampoule. The offered price includes the article and transport according to the call for tenders and covers all requirements set out in the Call for Tenders and it's Annexes.)
Quality: (The offered article has as long as possible registered shelf life. Shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point. A maximum of 10 points can be achieved.)
Quality: (50 % of the total quantity should be delivered as soon as possible. The tenderer receives points for increasing the capacity according to the menus in the Call for Tenders. A maximum of 40 points can be achieved.)
Quality: (The tenderer who is able to and will deliver English language packages with English language product information leaflets receives 15 points. To be eligible to receive the points, the English language leaflet should have been inspected and reviewed by National Competent Authority (NCA) or European Medicine Authority (EMA).)
Quality: (If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the supplier receives 10 points. The supplier shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.)
Quality: (If the product has an EMA centralized EU Marketing Authorisation, the supplier receives 25 points.)
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Lot nr.: 8
LOT 8: Pegfilgrastim 6 mg / 0,6 ml (0,6 ml per vial/ampoule/prefilled syringe, ATC L03AA13)
The subject of the procurement is article in accordance with the following requirements:
- The subject of tender: Pegfilgrastim 6 mg / 0,6 ml (0,6 ml per vial/ampoule/prefilled syringe, ATC L03AA13)
- Parenteral products (sub-cutaneous) for CBRN poisoning treatment or CBRN antidotes
- Active pharmaceutical ingredient: Pegfilgrastim
- Strength: 6 mg / 0,6 ml
- Pharmaceutical form: vial/ampoule/prefilled syringe
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.
Estimated quantity for the article is described in Annex 6 (restricted, TL IV). In addition to the estimated quantity indicated in the Annex 6, the Customer is entitled to purchase 100 % extra to the estimated quantities (later referred as "Option"). The Customer can use as much of the option as it needs. The Customer shall notify the Supplier by the end of June 2026 at the latest, if it wishes to exercise the Option. The delivery schedule for the Option will be agreed separately between the Contracting parties. The Supplier is not obliged to deliver the Articles under the Option.
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.
Type of contract: Supplies
Authority: Finnish Institute for Health and Welfare
Information URL:
https://thl.fi/en/web/thlfi-en
Duration contract months: 17
Criteria definitions: Price: (The reference price of the tender consist of the price of one (1) vial/ampoule/prefilled syringe. The offered price includes the article and transport according to the call for tenders and covers all requirements set out in the Call for Tenders and it's Annexes.)
Quality: (The offered article has as long as possible registered shelf life. Shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point. A maximum of 10 points can be achieved.)
Quality: (50 % of the total quantity should be delivered as soon as possible. The tenderer receives points for increasing the capacity according to the menus in the Call for Tenders. A maximum of 40 points can be achieved.)
Quality: (The tenderer who is able to and will deliver English language packages with English language product information leaflets receives 15 points. To be eligible to receive the points, the English language leaflet should have been inspected and reviewed by National Competent Authority (NCA) or European Medicine Authority (EMA).)
Quality: (If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the supplier receives 10 points. The supplier shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.)
Quality: (If the product has an EMA centralized EU Marketing Authorisation, the supplier receives 25 points.)
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Lot nr.: 9
LOT 9: Naloxone / single dose container (no further device assembly is required, ATC V03AB15)
The subject of the procurement is article in accordance with the following requirements:
- The subject of tender: Naloxone / single dose container (no further device assembly is required, ATC V03AB15)
- Solutions for nasal use for CBRN poisoning treatment or CBRN antidotes
- Active pharmaceutical ingredient: Naloxone
- Pharmaceutical form: single dose container (no further device assembly is required)
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.
Estimated quantity for the article is described in Annex 6 (restricted, TL IV). In addition to the estimated quantity indicated in the Annex 6, the Customer is entitled to purchase 100 % extra to the estimated quantities (later referred as "Option"). The Customer can use as much of the option as it needs. The Customer shall notify the Supplier by the end of June 2026 at the latest, if it wishes to exercise the Option. The delivery schedule for the Option will be agreed separately between the Contracting parties. The Supplier is not obliged to deliver the Articles under the Option.
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.
Type of contract: Supplies
Authority: Finnish Institute for Health and Welfare
Information URL:
https://thl.fi/en/web/thlfi-en
Duration contract months: 17
Criteria definitions: Price: (The reference price of the tender consist of the price of one (1) single dose container. The offered price includes the article and transport according to the call for tenders and covers all requirements set out in the Call for Tenders and it's Annexes.)
Quality: (The offered article has as long as possible registered shelf life. Shelf life of 3 years (36 months) or more receives 10 points. Shelf life less than 3 years (36 months) receives 0 point. A maximum of 10 points can be achieved.)
Quality: (50 % of the total quantity should be delivered as soon as possible. The tenderer receives points for increasing the capacity according to the menus in the Call for Tenders. A maximum of 40 points can be achieved.)
Quality: (The tenderer who is able to and will deliver English language packages with English language product information leaflets receives 15 points. To be eligible to receive the points, the English language leaflet should have been inspected and reviewed by National Competent Authority (NCA) or European Medicine Authority (EMA).)
Quality: (If the product can be delivered in any temperature between 2-40 °C without negative impact on the quality, the supplier receives 10 points. The supplier shall have the data from the stability studies that justifies the no quality impact in 2-40 °C temperature during the transportation.)
Quality: (If the product has an EMA centralized EU Marketing Authorisation, the supplier receives 25 points.)