The Ministry of Health of the Republic of Kosovo has expressed deep concern regarding several decisions of the Procurement Review Body (Decisions no. 397, 409/22, Decision no. 425/22 and Decision no. 596/22) through which tends to allow the procurement of drugs without a Marketing Authorization in Kosovo, despite the fact that this is expressly prohibited by the Law on Medicinal Products and Devices.
The Ministry of Health, through a communiqué, states that the marketing authorization is a permit granted by the Kosovo Agency for Medicinal Products and Devices for the approval of the medicine for the market based on meeting the requirements for quality, safety and efficiency for human use in therapeutic treatment.
“The Ministry of Health informs the public opinion that it has opposed all these decisions through court lawsuits and requested the suspension of the decisions until the final court decision is issued, and that we are convinced that the court will consider them as illegal. The risk posed to users of drugs without Marketing Authorization is high, since if we implement the aforementioned decisions of the PHS, then the Republic of Kosovo would effectively allow the uncontrolled import of drugs into our country and for any effect of unwanted drugs no one can be held responsible. This Authorization is an insurmountable basic condition for verifying the safety, quality and efficacy of medicines. As an institution, we have taken all measures to stop procurements without a Marketing Authorization, we have changed an Administrative Instruction 02/2014 that in the past has created ambiguity in the import of drugs, and we have asked all demand units that procurements be made only with Marketing Authorization, respectively in accordance with the provisions established by the respective law. Unfortunately, in this quality assurance reform, we are facing the senseless resistance of the PHS, which paradoxically has a mission to protect legality in public procurement and on the other hand, with these decisions, is helping pharmaceutical companies which refuse to register drugs for many years and risk creating pharmaceutical chaos in the country. There is no valid and acceptable justification for distributors of medicinal products not to be provided with Marketing Authorization according to the requirements of the Law but also of any standard for drug safety. The Ministry of Health is the authority that designs policies and monitors their implementation. As such an authority, we will not allow, under any circumstances, that in the Republic of Kosovo, the basic protocol for controlling the circulation of drugs is called into question. We remind you that this is not a commercial issue, but an essential issue of the mandate of the Ministry of Health and its agencies. Particularly worrying for the Ministry of Health was the report of the members of the PHS Board before the Parliamentary Committee on Budgets and Finances, where this issue was also discussed, and the PRB members attempted to present incorrect data, resulting in the decision in deviation of the members of this commission, on the grounds that the evaluation of the PHS is simply procedural. The PHS, with its own decisions, has made interpretations of the Law on Medical Products and Equipment , Administrative Instructions and the Law on Public Procurement and has concluded that products can be procured even without a Marketing Authorization, for this you can see decision no. 397, 409/22, where the PHS has determined that an Administrative Instruction has a greater value than the Law on Medical Products and Devices and has also deviated the content of the instruction”, says the reaction of the MoH, clarifying that the PHS took all these decisions, without consulting the responsible bodies, without engaging experts in the field of pharmacy and in violation of the Law on Medicinal Products and Equipment.
