Public procurement notice: Contract Notice
Published: 2020-09-09
Buyer: PHI University Clinic for radiotherapy and oncology
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Submission deadline: 2020-10-05
Award criteria: Lowest price

Technical requirements: Lääketieteelliset laitteet, farmaseuttiset valmisteet ja henkilökohtaiseen hygieniaan liittyvät tuotteet
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 continuously maintaining temperature from (2ºC-8ºC) with proper capacity for the offered drugs and requires special temperature regimen.
— the economic operator owns vehicle for transport and distribution of drugs (equipped for temperature regimen for keeping 2ºC-8ºC) for the offered drugs and requires special temperature regimen.
— 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;
— the economic operator provides sound and visual signalization from the cold chain to the person engaged for 24 hours monitoring of the cold chain;
— 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;
If the offered medicine does not have an approval for placing on the market ready-made medicine in RSM, there should be a temporary or permanent approval for parallel import in accordance with the Law on Medicines and Medical Devices issued by the Agency for Medicines and Medical Devices of RSM.
— certificate from the analysis of the quality of the medicine from the manufacturer that is subject to parallel import, attached in the original;
— certificate from the analysis of the quality of the drug from a laboratory authorized by the competent authority of the country, manufacturer of the drug or the country exporter of the drug, for performing the appropriate examination of the drug or laboratory authorized by the Agency, and for vaccines and drugs obtained by human blood processing or human plasma with OCABR certificate (Certificate for the release of a series of drugs on the market from an official laboratory for drug control) issued by a laboratory in the OMCL network; for unregistered drugs: the economic operator is required for the offered medicine to submit — approval for import of medicines with quantity/certificate for issuing a permit for import of unregistered drugs issued by the Agency for drugs and medical devices of RNM and if any selected as the most favorable bidder with each delivery of the drug is obliged to submit a Certificate for quality of the finished drug from the manufacturer not older than 3 years and approval for import of drugs with quantity.

Eligibility requirements: Certificate for registered activity.