Public procurement notice: Contract Notice
Published: 2016-10-26
Buyer: Ministry of Health
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Submission deadline: 2016-12-05
Award criteria: Lowest price

Technical requirements: Vaccines for continuous immunization and epidemiologically indicated immunization of the population in R. Macedonia for 2016 and 2018.
A statement that no verdict in force has been passed to the economic operator in the last 5 years for participation in a criminal organization, corruption, fraud or money laundry;
— certificate for paid taxes, contributions and other public expenses from a competent body from the country where the economic operator is registered;
— certificate that no sanction for prohibition for participating in public procurement procedures, awarding public procurement contracts and contract for public-private partnerships is issued by the Sanction register for committed criminal acts of legal entities
— certificate that no sanction for permanent or temporary prohibition for performing of separate activity is issued by the Sanction register for committed criminal acts of legal entities
— Certificate that no offence sanction has been passed by verdict in force — prohibition from practising a profession, activity or duty that is temporary prohibition from exercising a certain duty.
Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import
— Show proof of certificate for the pharmaceutical product, issued by competent body, at least 3 years valid (CPP certificate) for the procurement subject that hasn't been approved for trading in Macedonia or temporary approval for parallel import or final approval for parallel import, as proof that the procurement subject is approved for trading in a country member of EU, Norway, Switzerland, USA, Canada and Japan.
— Declare a statement that the conditions for vaccines safe keeping, accommodation, transport and managing are fulfilled pursuant to the Guidance for the conditions related to the space, equipment and human resources for awarding approval for whole sale trade with drugs (Off. Gazette of RM No. 151/08);
— Declare a statement that the economic operator owns — cold chamber for accommodation and keeping with automatic temperature reader which must continuously to maintain temperature of 2-8C.
— Declare a statement for provided sound and visual signalization form the chamber to the person for 24 hours monitoring of the cold chain.
— Submit a list of prequalified vaccines of WHO, except for parts: 11 and 12 of the technical specification;
— Submit certificate for trade with the medicine (OCABR — Official Control Authority Batch Release Certificate), in accordance with the EU recommendations, at least 3 years valid, except for part 21 of the technical specification;
— Declare a statement for equipment — Reserve (spare) electricity aggregate, which shall be activated in case of power failure or lack of electricity;

Eligibility requirements: A statement that no verdict in force has been passed to the economic operator in the last 5 years for participation in a criminal organization, corruption, fraud or money laundry; — certificate that no bankruptcy proceedings have been instituted by a competent body; — certificate that no liquidation proceedings have been instituted by a competent body; — certificate for paid taxes, contributions and other public expenses from a competent body from the country where the economic operator is registered; — certificate that no sanction for prohibition for participating in public procurement procedures, awarding public procurement contracts and contract for public-private partnerships is issued by the Sanction register for committed criminal acts of legal entities — certificate that no sanction for permanent or temporary prohibition for performing of separate activity is issued by the Sanction register for committed criminal acts of legal entities — Certificate that no offence sanction has been passed by verdict in force — prohibition from practising a profession, activity or duty that is temporary prohibition from exercising a certain duty. N/a. N/a. Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import — Show proof of certificate for the pharmaceutical product, issued by competent body, at least 3 years valid (CPP certificate) for the procurement subject that hasn't been approved for trading in Macedonia or temporary approval for parallel import or final approval for parallel import, as proof that the procurement subject is approved for trading in a country member of EU, Norway, Switzerland, USA, Canada and Japan. — Declare a statement that the conditions for vaccines safe keeping, accommodation, transport and managing are fulfilled pursuant to the Guidance for the conditions related to the space, equipment and human resources for awarding approval for whole sale trade with drugs (Off. Gazette of RM No. 151/08); — Declare a statement that the economic operator owns — cold chamber for accommodation and keeping with automatic temperature reader which must continuously to maintain temperature of 2-8C. — Declare a statement for provided sound and visual signalization form the chamber to the person for 24 hours monitoring of the cold chain. — Submit a list of prequalified vaccines of WHO, except for parts: 11 and 12 of the technical specification; — Submit certificate for trade with the medicine (OCABR — Official Control Authority Batch Release Certificate), in accordance with the EU recommendations, at least 3 years valid, except for part 21 of the technical specification; — Declare a statement for equipment — Reserve (spare) electricity aggregate, which shall be activated in case of power failure or lack of electricity; — Declare a statement for equipment — Refrigerator on temperature of -20 С for part 8 only POLIO vaccine in tender documents; Procurement subject must be approved for trading with medicines in Macedonia or to have obtained temporary approval for parallel import or final approval for parallel import — For the procurement subject that hasn't been approved for trading in Macedonia or has obtained temporary approval for parallel import or final approval for parallel import, the procurement subject must approved for trading in a country member of EU, Norway, Switzerland, USA, Canada and Japan. — conditions for vaccines safe keeping, accommodation, transport and managing are fulfilled pursuant to the Guidance for the conditions related to the space, equipment and human resources for awarding approval for whole sale trade with drugs (Off. Gazette of RM No. 151/08); — owns — cold chamber for accommodation and keeping with automatic temperature reader which must continuously to maintain temperature of 2-8C. — provided sound and visual signalization form the chamber to the person for 24 hours monitoring of the cold chain. — procurement subject must be on the list of prequalified vaccines of WHO, except for parts: 11 and 12 of the technical specification; — provided certificate for trade with the medicine (OCABR — Official Control Authority Batch Release Certificate), in accordance with the EU recommendations, at least 3 years valid, except for part 21 of the technical specification; — provided for equipment — Reserve (spare) electricity aggregate, which shall be activated in case of power failure or lack of electricity; — provided equipment — Refrigerator on temperature of -20 С for part 8 only POLIO vaccine in tender documents;
N/a. N/a.
N/a.
Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import — Show proof of certificate for the pharmaceutical product, issued by competent body, at least 3 years valid (CPP certificate) for the procurement subject that hasn't been approved for trading in Macedonia or temporary approval for parallel import or final approval for parallel import, as proof that the procurement subject is approved for trading in a country member of EU, Norway, Switzerland, USA, Canada and Japan. — Declare a statement that the conditions for vaccines safe keeping, accommodation, transport and managing are fulfilled pursuant to the Guidance for the conditions related to the space, equipment and human resources for awarding approval for whole sale trade with drugs (Off. Gazette of RM No. 151/08); — Declare a statement that the economic operator owns — cold chamber for accommodation and keeping with automatic temperature reader which must continuously to maintain temperature of 2-8C. — Declare a statement for provided sound and visual signalization form the chamber to the person for 24 hours monitoring of the cold chain. — Submit a list of prequalified vaccines of WHO, except for parts: 11 and 12 of the technical specification; — Submit certificate for trade with the medicine (OCABR — Official Control Authority Batch Release Certificate), in accordance with the EU recommendations, at least 3 years valid, except for part 21 of the technical specification; — Declare a statement for equipment — Reserve (spare) electricity aggregate, which shall be activated in case of power failure or lack of electricity; — Declare a statement for equipment — Refrigerator on temperature of -20 С for part 8 only POLIO vaccine in tender documents; Procurement subject must be approved for trading with medicines in Macedonia or to have obtained temporary approval for parallel import or final approval for parallel import — For the procurement subject that hasn't been approved for trading in Macedonia or has obtained temporary approval for parallel import or final approval for parallel import, the procurement subject must approved for trading in a country member of EU, Norway, Switzerland, USA, Canada and Japan. — conditions for vaccines safe keeping, accommodation, transport and managing are fulfilled pursuant to the Guidance for the conditions related to the space, equipment and human resources for awarding approval for whole sale trade with drugs (Off. Gazette of RM No. 151/08); — owns — cold chamber for accommodation and keeping with automatic temperature reader which must continuously to maintain temperature of 2-8C. — provided sound and visual signalization form the chamber to the person for 24 hours monitoring of the cold chain. — procurement subject must be on the list of prequalified vaccines of WHO, except for parts: 11 and 12 of the technical specification; — provided certificate for trade with the medicine (OCABR — Official Control Authority Batch Release Certificate), in accordance with the EU recommendations, at least 3 years valid, except for part 21 of the technical specification; — provided for equipment — Reserve (spare) electricity aggregate, which shall be activated in case of power failure or lack of electricity; — provided equipment — Refrigerator on temperature of -20 С for part 8 only POLIO vaccine in tender documents;
Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import — Show proof of certificate for the pharmaceutical product, issued by competent body, at least 3 years valid (CPP certificate) for the procurement subject that hasn't been approved for trading in Macedonia or temporary approval for parallel import or final approval for parallel import, as proof that the procurement subject is approved for trading in a country member of EU, Norway, Switzerland, USA, Canada and Japan. — Declare a statement that the conditions for vaccines safe keeping, accommodation, transport and managing are fulfilled pursuant to the Guidance for the conditions related to the space, equipment and human resources for awarding approval for whole sale trade with drugs (Off. Gazette of RM No. 151/08); — Declare a statement that the economic operator owns — cold chamber for accommodation and keeping with automatic temperature reader which must continuously to maintain temperature of 2-8C. — Declare a statement for provided sound and visual signalization form the chamber to the person for 24 hours monitoring of the cold chain. — Submit a list of prequalified vaccines of WHO, except for parts: 11 and 12 of the technical specification; — Submit certificate for trade with the medicine (OCABR — Official Control Authority Batch Release Certificate), in accordance with the EU recommendations, at least 3 years valid, except for part 21 of the technical specification; — Declare a statement for equipment — Reserve (spare) electricity aggregate, which shall be activated in case of power failure or lack of electricity; — Declare a statement for equipment — Refrigerator on temperature of -20 С for part 8 only POLIO vaccine in tender documents;
Procurement subject must be approved for trading with medicines in Macedonia or to have obtained temporary approval for parallel import or final approval for parallel import — For the procurement subject that hasn't been approved for trading in Macedonia or has obtained temporary approval for parallel import or final approval for parallel import, the procurement subject must approved for trading in a country member of EU, Norway, Switzerland, USA, Canada and Japan. — conditions for vaccines safe keeping, accommodation, transport and managing are fulfilled pursuant to the Guidance for the conditions related to the space, equipment and human resources for awarding approval for whole sale trade with drugs (Off. Gazette of RM No. 151/08); — owns — cold chamber for accommodation and keeping with automatic temperature reader which must continuously to maintain temperature of 2-8C. — provided sound and visual signalization form the chamber to the person for 24 hours monitoring of the cold chain. — procurement subject must be on the list of prequalified vaccines of WHO, except for parts: 11 and 12 of the technical specification; — provided certificate for trade with the medicine (OCABR — Official Control Authority Batch Release Certificate), in accordance with the EU recommendations, at least 3 years valid, except for part 21 of the technical specification; — provided for equipment — Reserve (spare) electricity aggregate, which shall be activated in case of power failure or lack of electricity; — provided equipment — Refrigerator on temperature of -20 С for part 8 only POLIO vaccine in tender documents;