Changes to Drug Import Regulations

The adoption of the draft is aimed at eliminating existing discrepancies in the regulation of drug circulation, implementing a clearer toolkit for ensuring the quality, safety, and accessibility of drugs, effectively carrying out regulatory functions, and harmonizing Armenia's legislation with the rules adopted within the framework of the Eurasian Economic Union.

This was stated by the Deputy Minister of Health of Armenia, Astghik Grigoryan, while presenting the draft law on amendments and changes to the "Law on Drugs" during the regular session of the National Assembly’s Standing Committee on Health Issues held on May 21.

It was noted that several gaps, contradictions, and misinterpretations have been identified during the implementation of the law, which hinder the full regulation of the sector. In addition to other changes, the draft proposes to make several modifications and additions to Article 21 of the law, allowing for the import of non-registered drugs listed as essential medicines, as well as anti-neoplastic and immunomodulatory drugs used in oncology. This is necessary because it is impossible to ensure the presence of only registered drugs in the list of essential medicines for at least the reason that registration has a limited duration.

Furthermore, there are numerous cases when a registered drug is not imported for a long time and is unavailable in the market. At the same time, it is proposed to clarify the grounds for refusing to issue an import certificate.

The expected outcome of the draft's adoption is to regulate the drug circulation sector more clearly and comprehensively, ensuring the quality, safety, affordability, and uninterrupted supply of drugs.

Astghik Grigoryan responded to questions from the deputies regarding free drugs, increasing the awareness of pharmacy staff regarding their distribution, harmonization of national legislation with the EAEU, and more.

The committee has given a positive conclusion to the draft.