Public procurement notice: Contract Notice
Published: 2023-04-17
Buyer: University Clinic for Rheumatology Skopje
Country: MK
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33000000
Submission deadline: 2023-05-08
Award criteria: Lowest price

Technical requirements: Lääketieteelliset laitteet, farmaseuttiset valmisteet ja henkilökohtaiseen hygieniaan liittyvät tuotteet
L04AB02 Infliximab (biosimilar) 100 mg. powder concentrate for solution for infusion, quantity 350 vials
- Certificate of registered activity as proof that it is registered as a natural or legal person to perform the activity related to the subject of procurement or proof that it belongs to an appropriate professional association in accordance with the regulations of the country where it is registered, and
-Marketing Authorization in the Republic of Macedonia to submit Marketing Authorization in a Member Stateof EU, Norway, Switzerland, USA, Canada or Japan; (if in the Republic of Macedonia for the respective ATSalready there is an marketing authorization issued by MALMED, in which case take into account the approvals for the drugs that are not registered in the Republic of Macedonia, even though they have an approval formarketing in EU Member States, Norway, Canada, USA, Japan and Switzerland).
-Certificate of quality of finished medicine from the manufacturer of the same, not older than 3 years, and / or OCABR Certificate (Certificate for placing a batch of drug on the market from an official laboratory for drug control) issued by a laboratory in the OMCL network, attached in original, in paper form, on the day of the public opening of the bids;
- Statement from the Economic Operator that upon delivery of the drugs, will submit a Certificate of quality of the finished drug from the manufacturer, no older than 3 years and / or OCABR Certificate (Certificate for placing a batch of medicinal roduct on the market from official Drug Control Laboratory) issued by a laboratory in the OMCL network, for each batch subject to delivery.
- Statement from the Economic Operator that the delivery of medicines will performs it at the temperature regime for distribution, transport and storage of biological drugs, and that during each delivery shall provide the contracting authority with proof hereof.
- The offered drugs to have a Decision for placing on the market of the drug in the Republic of Macedonia or temporary or permanent approval for parallel import, in accordance with the Law on Drugs and Medical Devices in RM issued by the Agency for Drugs and Medical Devices MALMED or if there is no Approval for the respective ATS marketing in the Republic of Macedonia to submit Marketing Authorization in an EU member state, Norway, Switzerland, USA, Canada or Japan;(if in the Republic of Macedonia for the respective ATS thereis already an approval for placing on the market of a drug issued by MALMED, in that case the approvals for the drugs that are not registered in the Republic of Macedonia will not be taken into account, even though they have  an approval for placing on the market in EU member states, Norway, Canada, USA, Japan and Switzerland) .
- The offered drugs to have a Certificate of quality of ready-made medicine from the manufacturer of the same, not older than 3 years, and / or OCABR certificate (Certificate for placing a batch of medicine on the market from an official drug control laboratory) issued by a laboratory in OMCL the network to be attached in the original;
- The offered medicines must have a Certificate of quality of ready-made medicine from the manufacturer, not older than 3 years and / or OCABR certificate (Certificate for placing a batch of medicine on the market from an official medicine control laboratory) issued by a laboratory in the OMCL network, for batch subject to delivery
- The delivery of drugs to be done by temperature regime, in accordance with the legal regulations relating to the distribution, transport and storage of biological drugs.

Eligibility requirements: - Certificate of registered activity as proof that it is registered as a natural or legal person to perform the activity related to the subject of procurement or proof that it belongs to an appropriate professional association in accordance with the regulations of the country where it is registered, and - Decision for wholesale of drugs in accordance with the Law on Drugs and Medical Devices