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RESOLUTION OF THE CABINET OF MINISTERS OF THE AZERBAIJAN REPUBLIC

of September 25, 2024 No. 443

About introduction of amendments to some resolutions of the Cabinet of Ministers of the Azerbaijan Republic in connection with execution of the Presidential decree of the Azerbaijan Republic of June 3, 2024 No. 81 "About introduction of amendments to some decrees and orders of the President of the Azerbaijan Republic in connection with execution of the laws of the Azerbaijan Republic of April 23, 2024 No. 1142-VIQD "About introduction of amendments to some laws of the Azerbaijan Republic in connection with application of the Law of the Azerbaijan Republic of July 14, 2023 No. 979-VIQD "About introduction of amendments to the Law of the Azerbaijan Republic "About medicines" and "About introduction of amendments to the Law of the Azerbaijan Republic "About medicines" of July 14, 2023 No. 979-VIQD "and" about introduction of amendments to some laws of the Azerbaijan Republic" of April 23, 2024 No. 1142-VIQD" in connection with implementation of the Law of the Azerbaijan Republic "About introduction of amendments to the Law of the Azerbaijan Republic "About medicines" of July 14, 2023 No. 979-VIQD

(Extraction)

Being guided by part eight of article 119 of the Constitution of the Azerbaijan Republic, for the purpose of ensuring execution of part 2 of the Presidential decree of the Azerbaijan Republic of June 3, 2024 No. 80 "About introduction of amendments to the Law of the Azerbaijan Republic "About medicines" of July 14, 2023 "About introduction of amendments to some laws of the Azerbaijan Republic in connection with application of the Law of the Azerbaijan Republic No. 979-VIQD of July 14, 2023" About modification of the Presidential decree of the Azerbaijan Republic No. 622 of July 25, 1997 "About application of the Law of the Azerbaijan Republic No. 1142-VIQD of April 23, 2024 and application of the Law of the Azerbaijan Republic "About public health care" and the Presidential decree of the Azerbaijan Republic of June 3, 2024 No. 81 "About introduction of amendments to the Law of the Azerbaijan Republic "About medicines" No. 979-VIQD of July 14, 2023 and "About introduction of amendments to some laws of the Azerbaijan Republic in connection with execution of the Law of the Azerbaijan Republic No. 979-VIQD of July 14, 2023 "and" about introduction of amendments to some decrees and orders of the President of the Azerbaijan Republic in connection with execution of the Law of the Azerbaijan Republic No. 1142-VIQD of April 23, 2024", the Cabinet of Ministers of the Azerbaijan Republic decides:

1. In the third paragraph of part 3 "Regulations on the state system of the Azerbaijan Republic according to the prevention of emergency situations and actions in such cases", the Cabinet of Ministers of the Azerbaijan Republic approved by the Resolution of April 30, 1992 No. 239 (Collection of the legislation of the Azerbaijan Republic, 2004, No. 9, Article 750 (volume I)," the words "medical equipment" shall be replaced with words "medical devices".

10. Make the following changes to "The rule of import of medicines to the Azerbaijan Republic research establishments for the purpose of research of their production, quality, safety and efficiency", approved by the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of July 25, 2007 No. 116 (Collection of the legislation of the Azerbaijan Republic, 2007, No. 7, Article 740 (volume I):

10.1. Regarding 1 word "not being subject to state registration in the Azerbaijan Republic" shall be replaced with words "the medicines which are not included in the state register (further - the state register)";

10.2. Add with part of 1-1 following content:

"1-1. For the purposes of this provision medicinal substances are considered equivalent to medicines.";

10.3. In parts 2, shall be replaced with words 3 and 6-8 words "not registered in the Azerbaijan Republic" "not included in the state register";

10.4. In Item 3.1 of the word "not being subject to state registration" shall be replaced with words "not included in the state register".

11. Make the following changes to "The rule of import of medicines to the Azerbaijan Republic in the humanitarian purposes", approved by the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of September 25, 2007 No. 141 (Collection of the legislation of the Azerbaijan Republic, 2007, No. 9, Article 917 (volume I)):

11.1. Add with part of 1-1 following content:

"1-1. For the purposes of these rules medicinal substances are considered equivalent to medicines.";

11.2. In the paragraph the second shall be replaced with words parts 2 of the word "not being subject to state registration in the Azerbaijan Republic" "not included in the state register of medicines (further - the state register)";

11.3. Regarding 4 words "not being subject to state registration in the Azerbaijan Republic" shall be replaced with words "not included in the state register";

11.4. On Item 5.1:

11.4.1. To exclude words from the first paragraph" (except for the medical products applied to diagnostics and treatment of diseases)";

11.4.2. in paragraph seven to replace the word of "set" with the word of "party";

11.5. In Item 5.2 of the word "Medical Products (Medical Products, Products and Materials, Tools, the Equipment, Medical Reagents and Optical Accessories) Applied to Diagnostics and Treatment of Diseases (Further — Medical Products)" shall be replaced with words "Medical products";

11.6. State Item 11.3 in the following edition:

"11.3. "if medicine is not included in the state register, taking into account paragraph two of part of 2 these rules;"

15. Make the following changes to the "Rules of carrying out scientific research, preclinical researches and clinical testing of medicines" approved by the resolution of the Cabinet of Ministers of the Azerbaijan Republic of April 30, 2010 No. 83 (Collection of the legislation of the Azerbaijan Republic, 2010, No. 4, Article 373 (volume I):

15.1. in Item 2.8 the word "standards" shall be replaced with words "technical regulatory legal acts";

15.2. in Item 2.9 and Item 2.23 (in both cases) shall be replaced with words the word "registration" "state registration";

15.3. On Item 2.26:

15.3.1. In the first offer shall be replaced with words the word "registration" "state registration";

15.3.2. in the fourth offer shall be replaced with words the word "Registration" "State registration";

15.4. In Item 5.5 of the word "it is not registered" shall be replaced with words "did not undergo state registration".

21. In subitem 2.1.7 of "The preferential and simplified rules of movement of the goods not of production or commercial appointment as physical persons" approved by the resolution of the Cabinet of Ministers of the Azerbaijan Republic of October 14, 2013 No. 305 (Collection of the legislation of the Azerbaijan Republic, 2013, No. 10, Article 1223 (volume I); 2024, No. 2, Article 217, No. 3, Article 314, No. 4, Article 468) shall be replaced with words the words "unregistered" "the unregistered medicines, and also specified in article 9.6 of the Law of the Azerbaijan Republic "About medicines".

23. In Item 18.4 of the "Rules of trade, public catering, consumer services and other types of service in the Azerbaijan Republic" approved by the resolution of the Cabinet of Ministers of the Azerbaijan Republic of April 3, 2014 No. 94 (Collection of the legislation of the Azerbaijan Republic, 2014, No. 4, Article 440 (volume I); 2024, No. 1, Article 85, No. 4, Article 444), the words "goods of medical appointment" shall be replaced with words "medical products".

26. Make the following changes to "The rule of declaration of goods and the vehicles moved through customs border", approved by the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of July 22, 2014 No. 263 (Collection of the legislation of the Azerbaijan Republic, 2014, No. 7, Article 951 (volume I); 2024, No. 3, article 314, No. 5 (book II), Article 612; The Resolution of the Cabinet of Ministers of the Azerbaijan Republic of July 22, 2024 No. 350):

26.1. In subitem 2.6.10 after the word "goods" to add with words "(except for medicines and medical products, and also pharmaceutical substances according to the Law of the Azerbaijan Republic "About medicines")";

26.2. Add with Item 2.6-3 of the following content:

"2.6-3. When importing medicines and products of medical appointment, and also medicinal substances instead of the documents specified in subitem 2.5.1 of these rules, customs authorities check availability of data on the import permit of medicines issued by the Ministry of Health of the Azerbaijan Republic according to the Law of the Azerbaijan Republic "About medicines".

28. Tabular part of Item 3.1 of "The amount of the customs duties" approved by the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of April 26, 2016 No. 168 (Collection of the legislation of the Azerbaijan Republic, 2016, No. 4, Article 823 (volume I); 2024, No. 1, Article 77) to replace in the column 2 of Item 3.23 of part 3 "Determination of the country of goods' origin, culture of production and quality in the course of conversion of" the word "of medicines and biologically active foodstuff and their substances" shall be replaced with words "medicines and medical products, and also medicinal substances, biologically active foodstuff".

31. In the second column of the line relating to goods item 4818 parts 7 of "The commodity nomenclature of foreign economic activity of the Azerbaijan Republic, rates of import customs duties and rates of export customs duties" approved by the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of November 17, 2017 No. 500 (Collection of the legislation of the Azerbaijan Republic, 2017, No. 11, Article 2164 (volume I); 2024, No. 1, Article 127, No. 2, Article 244, No. 4, Article 465; Resolutions of July 3, 2024 No. 330, of July 17, 2024 No. 342 and of September 3, 2024 No. 382), the words "medicines" shall be replaced with words "medical devices".

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