Regarding the Characteristics of Drug Import and Sale
- 2023-03-16
By decision of the Health and Labor Inspection Body of Armenia, the director of a company was held administratively liable with a fine of 200,000 AMD for the sale of a drug not registered in Armenia. The legal basis cited was Articles 16, Part 1, and 23, Part 2 of the Law on Medicines of Armenia.
It was found that an expert examination of the imported drug revealed a discrepancy between the form of the imported drug and that of the drug registered in Armenia. There are already multiple judicial decisions in effect that affirm that such discrepancies are considered formal in nature. Nevertheless, the inspection body ignored these facts and, based on the results of the examination, imposed a fine on the company's director.
The imposed fine was contested in the administrative court. In the petition, we stated that the administrative body did not include in the descriptive part of its decision any factual data that could indicate the sale of the drug. In other words, the inspection body referred to a legal norm that prescribes administrative liability for the sale of a drug, but the decision's factual part lacked any justification for such an act.
It should be noted that the plaintiff, in order to assess the legal risks of their entrepreneurial activities, had checked the compliance of the imported drug with the drug listed in the State Register of Medicinal Products of Armenia. After confirming that the drug met all its legal conditions, the plaintiff reasonably concluded that the storage of the drug was legal and did not violate Armenian legislation. Therefore, given the absence of necessary factual data and supporting evidence for the adoption of the decision, and the fact that the plaintiff had not been informed of the alleged violation, as well as the expiration of the two-month term for administrative liability under the Administrative Offenses Code, the petitioners requested that the decision of the Head of the Health and Labor Inspection Body be annulled.
The court noted that, in essence, the importation of a drug not registered in Armenia and the unlawful importation of a drug into Armenia are different acts in terms of content. None of these acts prescribe the sale of a drug not registered in Armenia (except in cases specified by Armenian legislation) or the sale of a drug whose registration has been suspended under the laws of Armenia. In other words, in the final stage of the administrative process, the plaintiff was held administratively liable for an act for which no administrative violation report had been drawn up under the Administrative Offenses Code of Armenia. The materials of the case, including the contested decision, did not contain any indication of the sale of an unregistered drug in Armenia.
The court also rightly noted that even if the facts of the plaintiff importing an unregistered drug into Armenia and violating Armenian legislation regarding drug importation were accepted, there could be no discussion of the sale of an unregistered drug in Armenia. Moreover, the contested decision did not hold the plaintiff administratively liable for the unlawful importation of the drug into Armenia, and the materials of the administrative process, including the contested decision, did not provide any evidence regarding the further handling of the alleged violation, which was manifested in the unlawful importation of a drug.
The court concluded that the practical realization of the right to be heard during the proceedings can only occur at the current stage of the process when the administrative body examines the facts of the case and determines the applicable legal acts. During this phase, the main actions aimed at the adoption of the administrative act are performed, including the discovery of all relevant circumstances, the collection and evaluation of necessary evidence, and the comprehensive, complete, and objective discussion of the case. Furthermore, hearings during the current phase should be conducted with consideration that the participants still have the opportunity to influence the administrative body's decision.
In this case, the plaintiff received the notice about the hearing the day before the hearing, which cannot be considered an adequate time period for properly exercising their rights to defend themselves.
Based on all the above, the court concluded that the claim was well-founded and should be granted.
Note: The ruling in the case No. VD/4526/05/20 of the Administrative Court of Armenia has entered into legal force.