Public procurement notice: Contract Notice
Published: 2018-12-20
Buyer: Drugs and Medical Aids Bureau
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Submission deadline: 2019-01-30
Award criteria: Lowest price

Technical requirements: Lääketieteelliset laitteet, farmaseuttiset valmisteet ja henkilökohtaiseen hygieniaan liittyvät tuotteet
Oncologic, immunologic and hematologic drugs for UC for radiology and oncology Skopje and PHI UC for hematology Skopje
A statement that no verdict in force has been passed to the economic operator in the last 5 years for participation in a criminal organisation, 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 pursuant to the Law on drugs and medical aids in RM,
— If the drug does not have trade approval in RM, then approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan,
— Declare a statement that the conditions for drugs 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 with automatically integrated thermometer from (20-80C for the offered drugs which require this range) and temperature reader for the drugs chamber and requires special temperature regimen,
— Declare a statement that the economic operator owns vehicle for transport and distribution of drugs (equipped for temperature regimen for keeping 20-80C),
— Declare a statement for engaged 24 hours available person for monitoring of the cold chain functioning and signalisation in case of variations in the temperature range,
— M1/M2 forms for at least 1 full time employed pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs),

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 organisation, 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. — Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import pursuant to the Law on drugs and medical aids in RM, — If the drug does not have trade approval in RM, then approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan, — Declare a statement that the conditions for drugs 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 with automatically integrated thermometer from (20-80C for the offered drugs which require this range) and temperature reader for the drugs chamber and requires special temperature regimen, — Declare a statement that the economic operator owns vehicle for transport and distribution of drugs (equipped for temperature regimen for keeping 20-80C), — Declare a statement for engaged 24 hours available person for monitoring of the cold chain functioning and signalisation in case of variations in the temperature range, — M1/M2 forms for at least 1 full time employed pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs), — Declare a statement for equipment – Reserve (spare) electricity aggregate for the cold chain, — Certificate issued by MALMED that the cold chain system is functional and signalises in case of variations in the temperature range and the aggregate is also functional, — Declare a statement that at the moment of reception of the drugs, the expiry date shall be at least 2/3 valid out of the total drugs expiry date, — Declare a statement for full time employee with university degree in medicine or pharmacy in charge for pharmacovigilance and detection of problems in the drugs quality or errors in the drug’s series, submitting his/her data: name, surname, profession and contact phone in order to be available at any time, — Submit notice for the parts of the procurement contract which the economic operator intends to transfer to subcontractor. — Procurement subject must be approved for trading with drugs in Macedonia by obtained Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import pursuant to the Law on drugs and medical aids in RM, — If the drug does not have trade approval in RM, then approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan, — The conditions for drugs safe keeping, accommodation, transport and managing must be 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), — The economic operator owns - cold chamber for accommodation with automatically integrated thermometer from (20-80C for the offered drugs which require this range) and temperature reader for the drugs chamber and requires special temperature regimen, — The economic operator owns vehicle for transport and distribution of drugs (equipped for temperature regimen for keeping 20-80C) — The economic operator provides sound and visual signalisation from the cold chain to the person engaged for 24 hours monitoring of the cold chain, — The economic operator owns reserve (spare) electricity aggregate for the cold chain which shall be functional and activated in case of power failure or lack of electricity, — Guarantee that at the moment of reception of the drugs, the expiry date shall be at least 2/3 valid out of the total drugs expiry date, — Full time employee with university degree in medicine or pharmacy in charge for pharmacovigilance and detection of problems in the drugs quality or errors in the drug’s series, submitting his/her data: name, surname, profession and contact phone in order to be available at any time, — Engaged available person 24 hours a day for monitoring of the cold chain functioning and signalisation in case of variations in the temperature range — Employed pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs).
— Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import pursuant to the Law on drugs and medical aids in RM, — If the drug does not have trade approval in RM, then approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan, — Declare a statement that the conditions for drugs 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 with automatically integrated thermometer from (20-80C for the offered drugs which require this range) and temperature reader for the drugs chamber and requires special temperature regimen, — Declare a statement that the economic operator owns vehicle for transport and distribution of drugs (equipped for temperature regimen for keeping 20-80C), — Declare a statement for engaged 24 hours available person for monitoring of the cold chain functioning and signalisation in case of variations in the temperature range, — M1/M2 forms for at least 1 full time employed pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs), — Declare a statement for equipment – Reserve (spare) electricity aggregate for the cold chain, — Certificate issued by MALMED that the cold chain system is functional and signalises in case of variations in the temperature range and the aggregate is also functional, — Declare a statement that at the moment of reception of the drugs, the expiry date shall be at least 2/3 valid out of the total drugs expiry date, — Declare a statement for full time employee with university degree in medicine or pharmacy in charge for pharmacovigilance and detection of problems in the drugs quality or errors in the drug’s series, submitting his/her data: name, surname, profession and contact phone in order to be available at any time, — Submit notice for the parts of the procurement contract which the economic operator intends to transfer to subcontractor. — Procurement subject must be approved for trading with drugs in Macedonia by obtained Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import pursuant to the Law on drugs and medical aids in RM, — If the drug does not have trade approval in RM, then approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan, — The conditions for drugs safe keeping, accommodation, transport and managing must be 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), — The economic operator owns - cold chamber for accommodation with automatically integrated thermometer from (20-80C for the offered drugs which require this range) and temperature reader for the drugs chamber and requires special temperature regimen, — The economic operator owns vehicle for transport and distribution of drugs (equipped for temperature regimen for keeping 20-80C) — The economic operator provides sound and visual signalisation from the cold chain to the person engaged for 24 hours monitoring of the cold chain, — The economic operator owns reserve (spare) electricity aggregate for the cold chain which shall be functional and activated in case of power failure or lack of electricity, — Guarantee that at the moment of reception of the drugs, the expiry date shall be at least 2/3 valid out of the total drugs expiry date, — Full time employee with university degree in medicine or pharmacy in charge for pharmacovigilance and detection of problems in the drugs quality or errors in the drug’s series, submitting his/her data: name, surname, profession and contact phone in order to be available at any time, — Engaged available person 24 hours a day for monitoring of the cold chain functioning and signalisation in case of variations in the temperature range — Employed pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs).
— Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import pursuant to the Law on drugs and medical aids in RM, — If the drug does not have trade approval in RM, then approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan, — Declare a statement that the conditions for drugs 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 with automatically integrated thermometer from (20-80C for the offered drugs which require this range) and temperature reader for the drugs chamber and requires special temperature regimen, — Declare a statement that the economic operator owns vehicle for transport and distribution of drugs (equipped for temperature regimen for keeping 20-80C), — Declare a statement for engaged 24 hours available person for monitoring of the cold chain functioning and signalisation in case of variations in the temperature range, — M1/M2 forms for at least 1 full time employed pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs), — Declare a statement for equipment – Reserve (spare) electricity aggregate for the cold chain, — Certificate issued by MALMED that the cold chain system is functional and signalises in case of variations in the temperature range and the aggregate is also functional, — Declare a statement that at the moment of reception of the drugs, the expiry date shall be at least 2/3 valid out of the total drugs expiry date, — Declare a statement for full time employee with university degree in medicine or pharmacy in charge for pharmacovigilance and detection of problems in the drugs quality or errors in the drug’s series, submitting his/her data: name, surname, profession and contact phone in order to be available at any time, — Submit notice for the parts of the procurement contract which the economic operator intends to transfer to subcontractor.
— Procurement subject must be approved for trading with drugs in Macedonia by obtained Decision for trading with medicines in Macedonia or temporary approval for parallel import or final approval for parallel import pursuant to the Law on drugs and medical aids in RM, — If the drug does not have trade approval in RM, then approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan, — The conditions for drugs safe keeping, accommodation, transport and managing must be 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), — The economic operator owns - cold chamber for accommodation with automatically integrated thermometer from (20-80C for the offered drugs which require this range) and temperature reader for the drugs chamber and requires special temperature regimen, — The economic operator owns vehicle for transport and distribution of drugs (equipped for temperature regimen for keeping 20-80C) — The economic operator provides sound and visual signalisation from the cold chain to the person engaged for 24 hours monitoring of the cold chain, — The economic operator owns reserve (spare) electricity aggregate for the cold chain which shall be functional and activated in case of power failure or lack of electricity, — Guarantee that at the moment of reception of the drugs, the expiry date shall be at least 2/3 valid out of the total drugs expiry date, — Full time employee with university degree in medicine or pharmacy in charge for pharmacovigilance and detection of problems in the drugs quality or errors in the drug’s series, submitting his/her data: name, surname, profession and contact phone in order to be available at any time, — Engaged available person 24 hours a day for monitoring of the cold chain functioning and signalisation in case of variations in the temperature range — Employed pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs).