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<p>Azerbaijan will make changes to the procedure for state registration of medicines. In this regard, it is envisaged to amend the law “On Medicines” accordingly.</p>
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<p>According to the proposed changes, the import of medicines and samples of the substance (s) used in the manufacture of the medicine is carried out by the relevant executive authorities, enterprises engaged in the production and wholesale of pharmaceutical products, representative offices of a foreign manufacturer in Azerbaijan or, in the absence of a local representative office authorized by foreign manufacturer.</p>
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<p>Also, an amendment is made to article 8 of the law (State control of the quality, effectiveness and safety of medicines).</p>
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<p>A new paragraph is added to the article, according to which all medical and preventive enterprises, regardless of the form of ownership and legal form, the holder of the certificate of registration of medicines and his authorized person in accordance with the rules established by the relevant executive authority to ensure the safe use of these funds, carry out work on pharmacovigilance and appoint persons responsible for this area.</p>
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<p>A new paragraph 14-1.6 is added to Section 14-1 of the Act (Dietary Supplements).</p>
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<p>According to this paragraph, the trademark and trademark of biologically active food additives must not coincide with the trademark and trademark of a medicinal product registered by the relevant executive authorities.</p>
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<p>A new paragraph 16.5 is added to Section 16 of the Law (Dissemination of Information on Medicines).</p>
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<p>The paragraph notes that the persons responsible for pharmacovigilance of treatment and prophylactic enterprises, the owner of the drug registration certificate and the person authorized by him must provide the relevant executive authorities with information on side effects and other problems, as well as information on pharmacovigilance and report documents.</p>
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