Drug regulatory requirements in Armenia
Thursday, June 24, 2004 08:00 IST
Pharmaceuticals: Production, Labeling and Packaging requirements
According to Article 3 of the law on medicine of Armenia, organizations involved in importing/ exporting, producing, packaging and labeling pharmaceutical products should obtain a license from the Ministry of Health of Armenia and the Drug and Medical Technology Agency.
Drug and Medical Technology Agency
The Drug and Medical Technology Agency is responsible for the evaluation and registration of pharmaceuticals and devices; developing and adopting relevant legislation and regulation, based on international standards and experiences; evaluating materials and issuing licenses for import and export of pharmaceutical products; quality control of medicines; adverse drug reactions monitoring; drug information; and other functions.
The Drug and Medical Technology Agency includes the following departments: department of expertise and medicines evaluation; department for the rational use of drugs and adverse drug reaction monitoring; expert department for licensing import and export of pharmaceutical products; expert department for the professional study of pharmaceutical establishments; department on drug policy; department of narcotics control; department of information and publishing; department of pharmacoeconomics analysis; g.guelbenkian research and development and quality control laboratories.
In 1997, Armenia participated in a World Health Organization project on the development and implementation of National Good Pharmaceutical Practice (GPP) Standards and Quality Assurance. GPP standards have been elaborated and adopted by the Drug and Medical Technology Agency. Indicators for monitoring GPP standards have subsequently been developed and enforced, allowing the testing of pharmacy service effectiveness and drug production, storage, delivery, and quality assurance, as well as for the evaluation of pharmacists interventions as they dispense drugs and respond to patient symptoms.
According to Article 5 of the law on medicine, production of pharmaceutical products in Armenia may be implemented only by licensed companies, in accordance with procedures set by the Drug and Medical Technology Agency. Production of pharmaceuticals is controlled by the government. According to Article 7 of the law on medicine, companies producing pharmaceuticals are responsible for the quality of the product, appropriate storage, packaging and labeling. Medicine produced in Armenia must be registered by the Drug and Medical Technology Agency.
According to Article 15 of the law on medicine, only registered medicine is allowed to be imported, exported, produced, stored, and distributed in Armenia. the following pharmaceutical products have to be registered in Armenia: Medicines (including serums, vaccines, veterinary pharmaceuticals, homeopathic drugs), diagnostic products, herbal medicines, food, cosmetic additives, devices. the registration system in Armenia is based on the evaluation of a dossier that includes necessary pharmaceutical, pharmacological and clinical data about medicines.
Packaging and Labeling
According to Article 8 of the law on medicine, pharmaceuticals made in Armenia should be properly packaged and labeled. Labeling requirements are set by the Drug and Medical Technology Agency. Label, package, and user's manual should.