Medicine quality and safety controls to be strengthened in Armenia

ArmInfo. Medication quality and safety controls will be strengthened in Armenia. At an extraordinary session on June 30, the RA National Assembly Committee on Healthcare approved the amendments to the Law "On Medicines" submitted by the RA government for the second reading.

Introducing the amendments, RA Deputy Minister of Health Astghik  Grigoryan noted that no new proposals had been submitted by either  MPs or the government for the second reading. The bill aims to  clarify regulations governing drug circulation and improve access to  medications. Furthermore, the proposed amendments are intended to  eliminate discrepancies in current legislation, improve the  effectiveness of control mechanisms, and harmonize Armenian  regulations with those of the Eurasian Economic Union. Specifically,  one of the key amendments concerns drug manufacturers and suppliers.  It proposes clarifying the procedure for issuing certificates of  compliance with good manufacturing and good distribution practices.  The initial certificate will be issued based on general monitoring  after a license is issued, followed by ongoing inspections at  facilities and warehouses. The document also revises the grounds for  suspending and terminating licenses. Specifically, a drug  manufacturing license may be terminated if the drug is produced  without a good manufacturing practice certificate. Similar measures  are proposed for the wholesale distribution of drugs without a good  distribution practice certificate. A separate set of amendments  concerns the import of drugs. The draft proposes permitting the  import of certain unregistered drugs included in the list of  essential drugs, as well as immunomodulatory drugs used in oncology.  The rationale notes that it is impossible to ensure that only  registered drugs from the list of essential drugs are available on  the market, as registration has a limited period, and some registered  drugs are not imported for long periods and are effectively absent  from the market. It is also proposed to clarify the grounds for  refusing to issue an import certificate. Such grounds include  violation of transportation or storage conditions, including  temperature control, the presence of damaged packaging, recall of the  drug for reasons of safety, efficacy or quality, and obstruction of  the collection of samples for examination.

Furthermore, the draft clarifies regulations on parallel imports.  Importers will be able to apply to the authorized body for  preliminary parallel import permission before ordering and shipping a  drug. However, such permission will not be a prerequisite for  obtaining an import certificate. Significant changes are also  proposed for customs warehouses. According to the draft, customs and  other warehouses, as well as temporary storage areas where drugs,  pharmaceutical substances, medicinal plant materials, or  investigational pharmaceutical products are stored, will be required  to comply with licensing and certification requirements for proper  distribution activities. This provision will be deferred until six  months after the official publication of the law. The draft also  stipulates that after the adoption of post-registration changes  unrelated to quality, efficacy, and safety, drugs in previously  approved packaging may be sold if they were made before the adoption  of the change or within 180 calendar days thereafter. Another change  concerns drug advertising: the law is proposed to eliminate the  requirement to include information about the state registration of  the drug in advertisements, as this information is verified by the  authorized body when issuing an advertising permit.