Regarding the Characteristics of Orders Refusing the Importation of Medicines


  • 2023-03-07

By order of the Minister of Health of the Republic of Armenia, a pharmaceutical company was denied the importation of several medicines into the Republic of Armenia.
In the application to the court, it was argued that the order had been issued in violation of the law and should be annulled, as the content of the contested order did not clearly indicate the legal grounds for refusing the importation of each medicine, which rendered the administrative act unclear.
The court, after evaluating all the evidence in the case, rightly noted that the factual grounds underlying the contested administrative act were related to the non-compliance of some medicines with the manufacturer's standards, discrepancies in the quality indicators, dosage form, packaging, name, and expiration date of some medicines, and expired registration dates for certain medicines. However, there was no analysis of these facts, nor was any evaluation given to them; only the existence of these facts was recorded.
The court, referring to Article 21, Part 8, Clause 2 of the Law of the Republic of Armenia on Medicines, noted that the legal grounds for refusing the importation of medicines may be applied if the administrative act specifically cites the fact that the medicine is not registered in the Republic of Armenia. However, the content of the administrative act did not mention that the medicines being imported were not registered in the Republic of Armenia, nor did the administrative act provide any reasoning or conclusions regarding the lack of registration. As a result, the plaintiff was not ensured an effective opportunity to exercise their right to legal protection against the administrative act.
Therefore, the court concluded that the decision issued by the administrative body was unlawful, and accordingly, the claim was granted by annulling the decision to refuse the importation of the medicines.

Note:
The decision of the Administrative Court of the Republic of Armenia in case No. VD/1237/05/20 has entered into legal force.

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