The Order of the Minister of Health of the Republic of Armenia was again declared invalid

• 2021-09-13

A pharmaceutical company was denied the import of medicines into the Republic of Armenia. According to the Ministry of Health of the Republic of Armenia, the examination of the imported medicine revealed that there were certain differences between the registered and imported medicines, including additional instructions.
The court, after analyzing the applicable legal norms and aligning them with the factual circumstances of the case, concluded that the regulation of the import of medicines into the Republic of Armenia, the associated processes, and the issuance and denial of the certificate for the import of medicines is directly conditioned by the approval of a normative legal act by the Government of Armenia, which regulates the specifics of medicine importation. This normative act is the Decision No. 202-N adopted on February 28, 2019, and entering into force on March 28, 2019.
Given that the application for the import certificate for the medicines in question was submitted to the Minister of Health on October 9, 2018, and considering that the Government's Decision No. 202-N entered into force on March 28, 2019, the court rightly found that the legal grounds related to the import of medicines into the Republic of Armenia and the associated processes, including the issuance or denial of the import certificate, were not applicable to the medicines imported by the company, as the new regulations were not in effect at the time the application was submitted.
Regarding the disputed order's foundation, which is based on the Government's Decision No. 581 of September 20, 2000, regarding the import and export regulations for medicines and pharmaceutical products, the court observed that under the legal regulations of the "Law on Legal Acts" of Armenia, effective until April 7, 2018, the suspension of the action of a legal act automatically resulted in the suspension of any normative legal acts or legal norms adopted in accordance with or in execution of that legal act, unless otherwise specified in the legal act that suspends its action. Therefore, since Decision No. 581 of the Government of Armenia was adopted in execution of the "Law on Medicines" (HО-259) adopted on October 27, 1998, which was replaced by the "Law on Medicines" (HО-86-N) on May 17, 2016, and came into force on December 15, 2016, the court concluded that the action of Decision No. 581 was considered suspended, as the new law did not provide for any continuation of the operation of that decision.
Thus, the Administrative Court of Armenia, in accordance with Article 63, Part 1, Clause "a" of the Law on Administrative Procedures, declared the illegal administrative act of the Minister of Health of Armenia invalid and simultaneously noted that there was no need to address the company’s arguments regarding the registration of the medicines in the Republic of Armenia.

Notification:
The decision of the Administrative Court of Armenia in case No. VD/0032/05/19 has entered into legal force.