"On Amendments to the Law of the Republic of Azerbaijan "On Medicines" dated July 14, 2023 No. 979-VIQD of the Republic of Azerbaijan and on the Application of the Law of the Republic of Azerbaijan "On Medicines" of the President of the Republic of Azerbaijan dated February 6, 2007 Decree of the President of the Republic of Azerbaijan on amending Decree No. 528

Guided by clauses 19 and 32 of Article 109 of the Constitution of the Republic of Azerbaijan, I make a decision to ensure the implementation of the Law of the Republic of Azerbaijan No. 979-VIQD dated July 14, 2023 "On Amendments to the Law of the Republic of Azerbaijan "On Medicines" :

1. Let it be determined that:

1.1. In Articles 1.0.8, 1.0.23, 1.0.33, 1.0.37, 1.0.42, 4.3-1, second of Article 6.1 of the Law of the Republic of Azerbaijan "On Medicines" in the first and second (in both cases) sentences of the paragraph, in the first and second sentences of Article 6.8, in Article 7.2, in the first sentence of Article 9.6, 9-1.3, 9-1.15, 9-1.18, Articles 12-1.2, second sentence of Article 12-1.5, Articles 12-1.6, 12-1.7, first sentence of Article 13.2-1, 16.4 and 16.6 (in both cases) The President of the Republic of Azerbaijan exercises the powers of the relevant executive authority provided for in Articles;

1.2. The Cabinet of Ministers of the Republic of Azerbaijan exercises the powers of the body (institution) provided for in Article 1.0.33 and the first sentence of Article 6.8 of that Law in agreement with the President of the Republic of Azerbaijan;

1.3. in Article 16.6 of that Law (in the first case), "organ (institution)" means the Cabinet of Ministers of the Republic of Azerbaijan;

1.4. in Articles 1.0.8, 1.0.23, 1.0.37, 1.0.42, 4.3-1 of that Law, in the first and second (in both cases) sentences of the second paragraph of Article 6.1, 6.8 in the second sentence of Article 7.2, 9-1.3, 9-1.15, 12-1.2, in the second sentence of Article 12-1.5, in Articles 12-1.6, 12-1.7 , in the first sentence of Article 13.2-1 and Article 16.6 (in the second case) "body (institution)" means the Ministry of Health of the Republic of Azerbaijan;

1.5. in the first sentence of Article 9.6 of that Law, "body (institution)" means the Ministry of Health of the Republic of Azerbaijan and the Union of Management of Medical Territorial Units;

1.6. in Article 9-1.18 of that Law, "body (institution)" means the State Customs Committee of the Republic of Azerbaijan;

1.7. in Article 16.4 of that Law, "body (institution)" means the Tariff (Price) Council of the Republic of Azerbaijan.

2. The Cabinet of Ministers of the Republic of Azerbaijan:

2.1. prepare and submit to the President of the Republic of Azerbaijan within two months the proposals regarding the adaptation of the laws of the Republic of Azerbaijan and the acts of the President of the Republic of Azerbaijan to the Law of the Republic of Azerbaijan No. 979-VIQD dated July 14, 2023 "On Amending the Law of the Republic of Azerbaijan "On Medicines";

2.2. for four months:

2.2.1. in accordance with Article 1.0.33 of that Law, approve the list of countries and foreign (international) organizations to which the recognition of the foreign (international) registration of the medicinal product applies by agreeing with the President of the Republic of Azerbaijan;

2.2.2. in accordance with Article 1.0.35 of that Law, to approve the Regulations of the "Tracking and Tracking System of Medicines" by agreeing with the President of the Republic of Azerbaijan;

2.2.3. in accordance with the first sentence of Article 6.8 of that Law, Article 1.0.8, second paragraph of Article 6.1, 6.13, 6-1.2, 6-2.15, 6-2.17 and 6 of this Law - Approve the rules for state registration of medicinal products, medicinal substances and medical devices, including them in the state register and maintaining the state register by agreeing with the President of the Republic of Azerbaijan, taking into account Articles 2.19;

2.2.4. in accordance with Article 16.6 of that Law, determine the scope of information provided by the manufacturers of medicinal products produced in the Republic of Azerbaijan and inform the President of the Republic of Azerbaijan;

2.3. to take measures to finance the costs related to the formation, implementation and maintenance of the "Medicine Follow-up and Tracking System" to be created according to paragraph 3.2 of this Decree within the funds provided in the state budget in the current year, and to provide appropriate funds in the state budget projects in the following years;

2.4. To resolve other issues arising from the Law No. 979-VIQD dated July 14, 2023 of the Republic of Azerbaijan "On Amendments to the Law of the Republic of Azerbaijan "On Medicines".

3. Ministry of Health of the Republic of Azerbaijan:

3.1. approve the following regulatory legal acts within three months and inform the President of the Republic of Azerbaijan;

3.1.1. In accordance with Article 1.0.8 of the Law of the Republic of Azerbaijan "On Medicines", the list of medicines with a higher, high and (or) average risk level;

3.1.2. in accordance with Article 4.2.16 of that Law, the requirements for Reliable Manufacturing Practice;

3.1.3. according to the second sentence of Article 6.8 of that Law, the classification of medical devices depending on the degree of risk;

3.1.4. in accordance with Article 9-1.15 of that Law, the form of the permit for the import of medicinal products and medicinal substances;

3.1.5. in accordance with the first sentence of Article 13.2-1 of that Law, the list of medicinal products produced in the Republic of Azerbaijan;

3.2. In accordance with Article 1.0.35 of that Law, taking into account the "Rules for the formation, management, integration and archiving of state information resources and systems" approved by Decree No. 263 of the President of the Republic of Azerbaijan dated September 12, 2018, "Follow-up and ensure the creation of the "tracking system" by January 1, 2024 and take necessary measures together with the Ministry of Digital Development and Transport of the Republic of Azerbaijan for the integration of that information system into the Electronic Government Information System;

3.3. in accordance with Articles 1.0.42 and 4.2.15 of that Law, preparing clinical protocols, creating their electronic database and placing them on its official website, as well as all medical institutions, regardless of their organizational-legal and ownership form, as well as private medical activities to provide access to that electronic database for medical workers with the right to write prescriptions (doctors and paramedics of medical centers) for a period of four months;

3.4. the form of the prescription provided for in Article 12-1 of that Law, as well as the application of the system that allows writing prescriptions for medicinal products in electronic form, regardless of the organizational-legal and ownership form of all medical institutions, as well as medical personnel who have the right to write prescriptions engaged in private medical activities (doctors and paramedics of medical centers) to ensure their connection to that system from January 1, 2024;

3.5. To take necessary measures to resolve other issues arising from the Law No. 979-VIQD dated July 14, 2023 of the Republic of Azerbaijan "On Amending the Law of the Republic of Azerbaijan "On Medicines".

4. The Tariff (Price) Council of the Republic of Azerbaijan approved the tariffs of the simplified expertise services of medicinal products provided for in Article 4.5 of the Law of the Republic of Azerbaijan "On Medicinal Products", including the upper limit of the wholesale and retail prices of medicinal products within one month and informed the President of the Republic of Azerbaijan give

5. In the Decree No. 528 of the President of the Republic of Azerbaijan dated February 6, 2007 "On the implementation of the Law of the Republic of Azerbaijan "On Medicines" (Legislative Collection of the Republic of Azerbaijan, 2007, No. 2, Article 94, No. 11, Article 1111; 2009, No. 4, Article 226, No. 6, Article 417; 2014, No. 10, Article 1199; 2015, No. 3, Article 273, No. 9, Article 991; 2016, No. 12, Article 2065; 2017, No. 5, Article 830; 2018 , No. 10, Article 2016; 2019, No. 5, Article 840; 2022, No. 12, Article 1437) the following changes should be made in Part 2:

5.1. Paragraph 2.1 should be considered as paragraph 2.1-2, in that paragraph the words of the Law of the Republic of Azerbaijan "On Medicines" should be replaced by the words of "that Law", in the third case the word "second" should be replaced by the word "third" and from that paragraph "6.1 in the second paragraph (in the first case), the words 6.1-2, 6.8" should be removed;

5.2. Add clauses 2.1, 2.1-1, 2.1-3 and 2.1-4 in the following content:

"2.1. In Articles 1.0.8, 1.0.23, 1.0.33, 1.0.37, 1.0.42, 4.3-1, second of Article 6.1 of the Law of the Republic of Azerbaijan "On Medicines" in the first and second (in both cases) sentences of the paragraph, in the first and second sentences of Article 6.8, in Article 7.2, in the first sentence of Article 9.6, 9-1.3, 9-1.15, 9-1.18, Articles 12-1.2, second sentence of Article 12-1.5, Articles 12-1.6, 12-1.7, first sentence of Article 13.2-1, 16.4 and 16.6 (in both cases) The President of the Republic of Azerbaijan exercises the powers of the relevant executive authority provided for in Articles;

2.1-1. The Cabinet of Ministers of the Republic of Azerbaijan implements the powers of the relevant executive authority provided for in Article 6-1.2 of that Law in agreement with the President of the Republic of Azerbaijan;";

"2.1-3. The Cabinet of Ministers of the Republic of Azerbaijan exercises the powers of the body (institution) provided for in Article 1.0.33 and the first sentence of Article 6.8 of that Law in agreement with the President of the Republic of Azerbaijan;

2.1-4. in Article 16.6 of that Law (in the first case), "body (institution)" means the Cabinet of Ministers of the Republic of Azerbaijan;";

5.3. Remove the words "6.1" from paragraph 2.2;

5.4. In paragraph 2.3-1, the words "in articles 4.3-1, in the second paragraph of article 6.1 (in the second case), 6.1-1, 6.1-3" are replaced by "in the first sentence of article 6-1.1, 6- to be replaced by the words "1.3" and the words "in the first sentence of the article" should be added after the words "14-1.6" in that clause;

5.5. Add clauses 2.3-2 and 2.3-3 in the following content:

"2.3-2. in Articles 1.0.8, 1.0.23, 1.0.37, 1.0.42, 4.3-1 of that Law, in the first and second (in both cases) sentences of the second paragraph of Article 6.1, 6.8 in the second sentence of Article 7.2, 9-1.3, 9-1.15, 12-1.2, in the second sentence of Article 12-1.5, in Articles 12-1.6, 12-1.7 , in the first sentence of Article 13.2-1 and Article 16.6 (in the second case) "body (institution)" means the Ministry of Health of the Republic of Azerbaijan;

2.3-3. In the first sentence of Article 9.6 of that Law, "body (institution)" means the Ministry of Health of the Republic of Azerbaijan and the Union of Management of Medical Territorial Units;";

5.6. In paragraph 2.4, the words "and in articles 16.4" should be replaced by the word "in the article";

5.7. Add clause 2.4-1 in the following content:

"2.4-1. In Article 16.4 of that Law, "body (institution)" means the Tariff (Price) Council of the Republic of Azerbaijan;";

5.8. At the end of clause 2.5, replace the full stop with a semicolon and add clause 2.5-1 with the following content:

"2.5-1. In Article 9-1.18 of that Law, "body (institution)" means the State Customs Committee of the Republic of Azerbaijan.

6. Clauses 1.4 and 2.3-2 of this Decree (Article 12-1.2, second sentence of Article 12-1.5, 12-1.6 and 12-1.7 of the Law of the Republic of Azerbaijan "On Medicines" in relation to articles) shall enter into force on January 1, 2024.

Ilham Aliyev

President of the Republic of Azerbaijan