Azerbaijan: Client Alert On Amendments To The Law On Medicines

On 14 October 2016 the President of the Republic of Azerbaijan signed Amendments to the Law On Medical Products (the "Amendment Law").

The Amendment Law has introduced into the Law On Medical Products the following new concepts:

  • "equivalent medical products" means medical products possessing an identical active substance (substances), a pharmaceutical form and a single amount (dose) of a raw material;
  • "similar medical products" means medical products possessing an identical active substance (substances), a pharmaceutical form, but having a different single amount (dose) of a raw material and/or a single package; and
  • "biologically active food additives" means products with a prescribed daily consumption dose produced in a pharmaceutical manner out of bioactive substances of plant, animal, mineral or chemical origin and complexes thereof to enrich dietary intake.

Biologically active food additives

Under the Amendment Law, biologically active food additives may be recommended by a physician to strengthen the body and to enrich food. However, such food additives shall not be taken to replace medicines for the purpose of preventing or treating any diseases. It shall not be allowed to include biologically active food additives in a medical prescription.

Further, under the Amendment Law biologically active food additives may not have the same composition as medical products (and whether or not they have the same composition shall be determined by an expert examination).

Biologically active food additives must be labeled with a clear statement in distinctive bold letters that such additives are "Not a Medicine". The same information shall be provided in instructions for use and in advertisements of biologically active food additives.

Biologically active food additives may be sold at drugstores, food stores and special kiosks organized for such purpose in accordance with the applicable sanitary hygienic requirements.

Price regulation

According to the Amendment Law, the sale of state registered medicines without price regulation or at prices different from the regulated prices (excluding sales by public procurement or at prices lower than wholesale prices proposed to medical institutions) is prohibited.

The licenses of legal entities and physical persons violating these requirements three times within one year shall be suspended by the licensing authority for six months in accordance with the Law On Licenses and Permits.

According to the Amendment Law, importers of medical products and representative offices of foreign producers in Azerbaijan or their authorized representatives will be required to submit declarations, accounting documents and other necessary information to the Ministry of Health for the purpose of price regulation of registered medical products.

The Center for Analytical Examination of the Ministry of Health has issued a notice to importers of medical products and representative offices of foreign producers

The Center for Analytical Examination (the "CAE") has issued a notice stating that, in accordance with the Law of the Republic of Azerbaijan On Medical Products and the Decision of the Cabinet of Ministers, No 108, dated 13 July 2007, On state registration and maintaining a register of medical products, instructions on the use of medical products must be in the Azerbaijani language.

From 1 January 2017 the importation of medical products for which the instructions on use are not in the Azerbaijani language and not in the form approved by the Ministry of Health and the Council of Pharmacological Experts shall be prohibited.

The CAE has stated as follows: "Instructions for the use of medicines shall contain such important information as the pharmacological characteristics of the medicine, indications, contraindications and precautions, rules for disposal, usage together with other medicines, and side effects, terms of use during pregnancy and lactation periods, side effects, overdose symptoms and treatment instructions, storage (temperature regime and other important terms of storage), period of validity [and] the terms of sale (prescription medicines or over-the-counter medicines).

On 14 September 2016 the President of the Republic of Azerbaijan signed a Decree "On the Establishment of the Pirallahi Industrial Park"

Under the Presidential Decree, the Pirallahi Industrial Park, which will be dedicated to the pharmaceutical industry, has been established in the Pirallahi district of Baku. The purpose of the new industrial park is to ensure the sustainable development of non-oil industries, the further expansion of business activities in the field of manufacturing industry and the creation of competitive and innovative industries driven by advanced technologies, including the development and support of the pharmaceutical industry, reducing dependence on imports of pharmaceutical products, the promotion of local production in order to meet the needs of the population in pharmaceuticals and increasing employment in the sphere of production

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