Exceptional Import of non-registered medicines: a regulatory door for saving lives
RA applicable legislation provides a specific regulation regarding the medicine import to the territory of Armenia.
RA “Law on Medicine” (hereinafter: Law) provides the scope of the subjects permitted to import medicine in the territory of RA. The mentioned subjects are the following:
- Suppliers possessing a wholesale license for medicine
- Without processing a wholesale license according to the Law:
- legal entities or sole proprietors whose activities relate to drugs, pharmaceuticals, medicinal raw materials, testing, quality, efficacy and safety control within the scope and range required for these works,
- legal entities or sole proprietors importing medicines within the framework of charitable or humanitarian programs as defined by the relevant law
- legal entities and sole proprietors licensed for pharmaceutical production in the Republic of Armenia in case of import of pharmaceuticals and medicinal raw materials for production purposes,
- Representations or representatives of foreign manufacturers, import or export of samples for registration and / or testing (drugs, pharmaceuticals, pharmaceutical raw materials, pharmaceuticals being studied) and / or exhibits,
- Government institutions.
According to RA Law on Medicines it is permitted to import medicines to the territory of RA only which are registered in RA.
However RA Government Decision N 202 provides the following exception:
Physical person who is leaving for a foreign country or arriving from a foreign country is permitted to import or export medicines (either registered or non-registered) for the purposes of personal medical treatment to RA. The quantity of the medicines should be up to 10 titles, each of them 3 packages, if according to the medical prescription of the doctor is not justified a greater amount required for the treatment course.
If your company intends to import medicinal products to the territory of RA, the lawyers of our company can support you with both consultation and appropriate documentation in this matter.
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