Additional instructions are not a valid basis for declaring a drug as unregistered in the Republic of Armenia

• 2023-03-16

The Minister of Health of the Republic of Armenia issued another order regarding the rejection of drug importation.
The Ministry conducted an examination of the received samples and discovered that additional instructions were indicated on the external packaging of the imported drug. However, no analysis or legal assessment of this factual circumstance was made, and the Ministry merely recorded the presence of this fact.
Disagreeing with the rejection order, we presented our arguments, which mainly pointed to the following: the presence of additional instructions on the packaging, as a reason for rejection, should be directly linked to the legal grounds for rejection. However, the Minister had applied a legal norm that allows for the rejection of a drug import based solely on its lack of registration. In other words, the presence of additional instructions on the external packaging is not sufficient to prove that the drug is unregistered in Armenia.
Furthermore, the order also contained foreign-language justifications, which directly contradict the language requirements for administrative acts set out in the Law on the Fundamentals of Administrative Proceedings and Administrative Procedures of the Republic of Armenia.
In response to the lawsuit, the Minister of Health attempted to justify the administrative act. However, the court found that the justifications should have been reflected exclusively in the rejection order.
Based on the aforementioned reasoning, the court decided to annul the administrative act issued by the Minister of Health of the Republic of Armenia.

Note:
The ruling of the Administrative Court of the Republic of Armenia in case No. VD/1556/05/19 entered into legal force.