The Minister's Denial is Invalid

• 2021-09-14

The Minister of Health of the Republic of Armenia issued a decree denying the importation of two types of medicines by a pharmaceutical company into the Republic of Armenia.
The Minister's reasoning was that there were discrepancies between the registered and the imported medicines in Armenia.
During the proceedings, the Court, discussing the legal question of whether it was lawful for the Minister of Health of Armenia to deny the importation of the medicines based on the additional instructions on the external packaging and the package insert of the imported medicines, reasonably concluded that the administrative body had unlawfully concluded that the presence of additional instructions on the external packaging and package insert of the imported medicines was grounds for denying the importation, citing the lack of special warnings on the packaging or non-compliance with the registration sample.
In particular, according to the Court, the warning instructions imply specific guidance on the use of the medicine (e.g., storage temperature, minimum age for use, etc.), whereas the indications of the medicine refer to the conditions or situations in which the medicine can be used, such as the disease that the medicine is intended to treat.
As a result, the Court concluded that the administrative body applied an inapplicable legal norm when making the disputed administrative act. Therefore, the Court upheld the claim and declared the administrative act invalid.

Notification:
The decision of the Administrative Court of Armenia in case No. VD/0464/05/20 has entered into legal force and has not been appealed.