Public procurement notice: Contract Notice
Published: 2021-04-09
Buyer: Ministry of Health of Republic of North Macedonia
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Submission deadline: 2021-05-05
Award criteria: Lowest price

Technical requirements: Lääketieteelliset laitteet, farmaseuttiset valmisteet ja henkilökohtaiseen hygieniaan liittyvät tuotteet
Confirmation issued from authorised body for compliance of special criteria for performing legal business activity related to the public procurement subject. A decision issued by the Agency for drugs and medical aids of RM, approving whole sale trading with drugs.
• 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;
• 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;
• graduated pharmacist licensed to work in the procurement phases (reception, keeping and issuing drugs);
• 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 (20-80 ºC 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 20-80 ºC);
• declare statement for available sound, visual signalisation and alarm (SMS notification) from the chamber to the person responsible for 24 hours monitoring of 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 not older than 12 months.
The bidder submits certificate issued by the drugs bureau to the authorised person for procurement implementation, certifying that the cold chamber and alarm system in case of temperature variations and the aggregate are functional.
Note: in order to qualify, the bidder in addition to the bid, besides the standard documents (proof of personal status, capacity for professional activity; technical and professional status), submits: certificate for quality of drug product issued by the manufacturer no more than 3 year olds or certificate for trading with drug product issued by the manufacturer no more than 3 year olds; registration approval for whole sale trade with drugs or temporary or final approval for parallel import, pursuant to the Lawon drugs and medical aids issued by drugs bureau or if the medicine has not been approved — approval for trading in EU members, Norway, Switzerland, USA, Canada and Japan; declare a statement that at the moment of reception of the drugs, the expiry date shall be at least 12 months valid out of the total drugs expiry date.If the bid does not cover the requested certificates/registration approval/statement, shall be considered as unacceptable and as such rejected by the Public Procurement Commission.

Eligibility requirements: List and brief description of conditions: Confirmation issued from authorised body for compliance of special criteria for performing legal business activity related to the public procurement subject. A decision issued by the Agency for drugs and medical aids of RM, approving whole sale trading with drugs.