Law No. НО-153 amending Law No. HO-86-N “On Drugs”.

Article 7 establishes that expert organization created by the decision of the Government carries out expertise and professional surveillance in the field of state regulation of circulation of drugs. Article 14 establishes that the Government approves the procedure for issuing permits to conduct clinical tests on humans and veterinary medicinal products, the procedure for expertise for this purpose, the form of the testing report, the list of documents required for testing, establishing general and simplified testing procedures. The simplified procedure is applied in the presence of permit to conduct a clinical test issued by the competent authority of a member country of an international professional organization determined by the decision of the Government. Article 16 establishes that in the Republic of Armenia, registration of medicinal products is carried out according to general and simplified procedures, as well as according to the rules of the EAEU. The simplified procedure applies to medicinal products registered by the competent authority of a member country of international professional organizations determined by the decision of the Government of the Republic of Armenia, or that have passed the examination or preliminary qualification of the World Health Organization.