Law No. HO-86-N “On Drugs”.

This Law regulates the circulation of medicines, substances, herbal substances and preparations, and investigational medicinal products with the aim of securing safe, effective, qualitative, and affordable medicinal products and reliable information thereon to the population. This Law also defines the powers of the competent state authorities of the Republic of Armenia and the powers of entities involved in the circulation of medicinal products in this sphere. The circulation of medicinal products, substances, medicinal herb materials, and investigational medicinal products containing narcotics or psychotropic (psychoactive) substances shall be regulated by this Law unless the Republic of Armenia Law on Narcotics and Psychotropic (Psychoactive) substances directly provides otherwise. The Authorized Body of state government in the health sector shall carry out the following in the sphere of state regulation of the circulation of medicinal products: (a) policy of the Republic of Armenia Government in the sphere of circulation of medicinal products; (b) regulation of the circulation of medicinal products within the framework of its competence; (c) licensing the types of activities stipulated by law in the sphere of circulation of medicinal products, and oversight stipulated by law; (d) state registration of medicines; (e) organizing and carrying out expert examinations in the sphere of state regulation of the circulation of medicinal products; (f) issuance of a certificate for the registration of medicines, GMP, and GDP, and ensuring other inspections stipulated by this Law; (g) ensuring the maintenance of the medicines register; (h) ensuring the rational use of medicines, the pharmacovigilance, and development of appropriate recommendations; (i) international cooperation; (j) inter-agency cooperation; (k) development of state medicine policy programs and monitoring their implementation; and (l) Functions reserved for it by this Law and other laws. In the Republic of Armenia, it shall be permitted to manufacture, import, distribute, dispense, sell, and use medicinal products that are registered in the Republic of Armenia, except for medicinal products stipulated by this Law. The registration of medicinal product, refusal to register, and suspension and voiding of the registration of medicinal product shall, on the basis of an expect conclusion, be performed by the Authorized Body in accordance with the procedure established by the Republic of Armenia Government, except for veterinary vaccines, plasmas, and diagnostic materials, for which state registration, refusal to register, suspension, and voiding shall be reserved for the authorized state body in the field of agriculture under the procedure established by the Republic of Armenia Government. The Republic of Armenia Government shall approve the procedure of expert examinations performed for medicinal product registration, re-registration, and certificate maturity extension, defining the form of the conclusion issued on the basis of expert examination performed for registration, re-registration, and certificate maturity extension for new medicinal products, reproduced medicinal products, biosimilars, combinations of medicinal products, homeopathic medicinal products, biological medicinal products, including those derived from blood or plasma, immunological medicinal products, radioactive medicinal products, veterinary medicinal products (including animal fodder containing substances), herbal medicinal products (including those packaged in consumer packaging and labelled medicinal herb materials), and antiseptic and anti-parasitic medicinal products destroying disease agents for skin, mucous membrane, hair, and nails, as well as the insects carrying them and parasites. This Law consists of 10 Chapters divided into 31 Articles. Chapter 1 lays down general provisions. Chapter 2 regards state regulation of the circulation of medicinal products. Chapter 3 establishes key principles of the state policy for providing medicines to the population and the developing pharmaceutics. Chapter 4 regards the discovery of medicinal products, state registration of medicinal products and post-registration pharmacovigilance. Chapter 5 regards manufacturing of medicinal products, substances, and investigational medicinal products, processing of medicinal herb materials and preparation of medicines. Chapter 6 regards import and export of medicinal products. Chapter 7 regards trade of medicinal products. Chapter 8 regards information about medicinal products. Chapter 9 regards supervision in the sphere of medicinal products and establishes liability for the infringement of this Law. Chapter 10 lays down final and transitional provisions. 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.