27.01.2022 | Criminal case and mediation for the fact of registration of a drug as a dietary supplement in conditions of insufficient control

In the course of a study carried out in the State Interests Protection Department of the RA Prosecutor General’s Office, on the basis of a letter received from the RA Ministry of Economy, it was found out that the drug “NAC-Complex” was registered as a biologically active additive in the Unified Register of State Registration Certificates. The latter contains 600 mg․ "N-acetyl-L-cysteine" of an active substance, which, according to information received from the Ministry of Health of the Republic of Armenia, is an active substance with a proven pharmacological effect and is used for medicinal purposes. As a therapeutic drug, it has clear instructions, the active substance "acetylcysteine 600 mg" is a drug and cannot be used as an active biological additive. That is, it does not meet the safety requirements established by the technical regulations, and cannot receive state registration as a dietary supplement.


According to the legislation of the Republic of Armenia, the state control over the safety of both food products and materials in direct contact with food products, products subject to veterinary and phytosanitary control, as well as pesticides and agrochemicals is carried out by the Food Safety Inspectorate.


Thus, during the study, it was found out that the officials of the food safety supervision authority from July 2021, being notified that the maximum daily dose of acetylcysteine is 600 mg in the drug "NAC-complex", registered as a biologically active additive in the unified register of certificates of state registration and non-compliance with the safety requirements set forth in such technical regulations, did not take measures to suspend or terminate registration of the specified product.


As a result, non-compliant dietary supplement as a registered product continued to freely circulate on the territory of the Customs Union, which prevented the normal work of other bodies with supervisory powers in the Customs Union.


In the Department for the Protection of State Interests of the RA Prosecutor General's Office, a criminal case was initiated under Part 1 of Article 315 of the RA Criminal Code, the preliminary investigation of which was entrusted to the RA Investigative Committee.


At the same time, a letter was sent from the Prosecutor General's Office to the head of the Department for Coordinating the Work of the Inspection Bodies of the Office of the Prime Minister of the Republic of Armenia. It was proposed to discuss the issue of termination or suspension of the state registration of the drug NAC-complex, as well as to take appropriate measures to identify cases of registration of biologically active additives containing the drug, to discuss the legality of their registration.