The Decision of the Ministry of Health of the Republic of Armenia Was Declared Invalid

• 2024-09-29

The Minister of Health of the Republic of Armenia issued an order rejecting the import of three types of medicine by the company, based on the following grounds: the inconsistency of the imported medicines' packaging, the medicines not being registered in Armenia, and the inconsistency in the legal type and address of the holder of the registration certificate for the imported medicines.
Considering that the factual and legal grounds for the issuance of the aforementioned order were insufficient to justify the rejection of the medicines' import, the Plaintiff filed a claim stating that the administrative body did not have the jurisdiction to reject the import of the requested medicines based on Articles 21 (8) (2) and (7) of the "Medicines Law" of Armenia. This is because the medicine registration ledger in Armenia contains 11 indicators describing the medicines, among which the "quantity of excipient" mentioned in the factual grounds of the rejection was not included.
Furthermore, the Plaintiff argued that the administrative body had a legal obligation to ensure the proper maintenance of the medicines' registration ledger in Armenia, including the publication of the medicines' medical usage instructions and the general characteristics of the medicines on the official website of the competent authority. These obligations were not fulfilled during the administrative procedure for this case.
Additionally, the Plaintiff mentioned that the rejection of the medicines' import was based on information uploaded on a commercial entity’s electronic website, which is not a competent authority. According to Article 6 (1) (5) of the "Medicines Law" of Armenia, only the Ministry of Health, as the competent authority, has the right to organize and conduct the necessary examinations regarding medicines' circulation in Armenia.
Citing Articles 1 (2) and 50 (1) of the Civil Code, as well as the relevant provisions of the "Joint-stock Companies Law" of Armenia, the Court concluded that the company, "Academician Emil Gabrielyan Expert Center for Medicines and Medical Technologies," cannot be considered as an authority capable of performing an expert evaluation in the field of healthcare. The examination conducted by this private company cannot be equated with the examination conducted by the Ministry of Health of Armenia.
Upon reviewing the order, the Court found that the decision to reject the medicine imports was based on an expert opinion from the aforementioned private company, which does not have the legal authority to perform such an evaluation.
Thus, the Court concluded that the administrative act issued by the Ministry of Health was invalid and annulled it, as there were sufficient grounds to do so under Article 63 (1) of the "Principles of Administrative Procedure and Administrative Proceedings" Law of Armenia.

Notification:
The decision of the Administrative Court of Armenia in case number VD/1718/05/23 has entered into legal force.