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RESOLUTION OF THE CABINET OF MINISTERS OF THE AZERBAIJAN REPUBLIC

of July 13, 2007 No. 108

About approval of "Rules of state registration of medicines and maintaining their register"

(as amended on 13-03-2019)

For the purpose of ensuring execution of Item 1.3 of the Presidential decree of the Azerbaijan Republic "About use of the Law of the Azerbaijan Republic "About medicines" of February 6, 2007 the No. 528 Cabinet of Ministers of the Azerbaijan Republic decides:

1. Approve "Rules of state registration of medicines and maintaining their register" (are applied).

2. This resolution becomes effective from the date of signing

Prime Minister of the Azerbaijan Republic

Artur Rasi-Zade

 

Approved by the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of July 13, 2007 No. 108

Rules of state registration of medicines and maintaining their register

1. General provisions

1.1. These rules are prepared based on Item 1.3 of the Presidential decree of the Azerbaijan Republic "About use of the Law of the Azerbaijan Republic "About medicines" of February 6, 2007 No. 528 and determine rules of state registration of the medicines imported into the Azerbaijan Republic and made in the Azerbaijan Republic and also maintaining their state register.

1.2. These rules do not extend to the medical means applied to diagnosis, prevention and treatment of diseases (medical devices, products, objects and materials, tools and the equipment, medical reactive and optical accessories).

1.3. After carrying out by the Ministry of Health the Azerbaijan Republic or the structure authorized by it (further - the Ministry of Health) state registration of medicines the last are entered in the register of medicines of the Azerbaijan Republic and their import after gluing of control brands to the territory of the Azerbaijan Republic, production, realization, use in medicine in the territory of the Azerbaijan Republic, except for the particular cases determined by the Law of the Azerbaijan Republic "About medicines" is allowed.

1.4. According to the Law of the Azerbaijan Republic "About medicines" state registration there undergo the following medicines:

1.4.1. original medicines;

1.4.2. analogs (generics) of medicines;

1.4.3. new combinations of the medicines which underwent state registration;

1.4.4. medicines with the expired term of state registration;

1.4.5. medicinal substances (medicinal substances) which are used in production of medicines as active ingredient.

1.5. If in the data containing in registration documents of the medicine which underwent state registration there will be any changes, state registration of these changes is carried out.

1.6. In case of not address to terms and according to the procedure, the these rules determined in Item 3.7, behind carrying out state registration of changes in the data containing in registration documents of earlier registered medicines, state registration of these medicines is recognized invalid.

2. Basic concepts

In these rules the following concepts are used:

2.1. state registration of medicines - the system of measures providing registration in certain procedure and provision of the import permit to the Azerbaijan Republic, industrial production and use in the territory of the Azerbaijan Republic of medicines by results of examination of the relevant documents and (or) the carried-out testing for the purpose of use in medical practice;

2.2. medicines - the substances of natural, synthetic, biotechnical origin or mix of several substances having special pharmacological, biological activity and applied in certain dosage form to diagnosis, prevention, treatment of diseases of the person, contraception, rehabilitation of patients or change of condition and functions of human body;

2.3. medicinal substances (medicinal substances) having biological activity of substance natural (vegetable, animal, mineral, etc.), synthetic and biotechnological origin, capable to change condition and biological functions of human body, it is applied in production of medicines;

2.4. original medicines - the medicines introduced into circulation under the patented peculiar name;

2.5. analogs (generics) of medicines - the medicines made after the expiration of protection of exclusive patent laws on original medicines by other producers with the same structure, dose and form of activity of substance;

2.6. pharmacopoeian Article - the regulating document determining quality requirements, to packaging, conditions and storage durations, control of quality of medicines;

2.7. the registration certificate - the document confirming permission of state body to import of medicines to the territory of the Azerbaijan Republic, their production, realization and use in medicine in the territory of the Azerbaijan Republic;

2.8. registration number - the specification symbol appropriated to medicine;

2.9. the register of the registered medicines of the Azerbaijan Republic - databank of the medicines permitted to import to the territory of the Azerbaijan Republic, production, realization and use in medicine in the territory of the Azerbaijan Republic;

2.10. medicines of category "OTC" (over the counter) the medicines provided without recipe of the doctor;

2.11. active ingredient - the main medicinal substance (medicinal substance) which is used in production of medicines;

2.12. the registration document - document package, the medicines represented by the applicant for state registration and confirmatory safety, efficiency and quality.

3. Procedure for the address for state registration

3.1. For registration of medicines on which the term of registration expired, and registration of changes in the data containing in registration documents of earlier registered medicine, person authorized by the producer (further - the applicant) addresses with the letter to the Ministry of Health.

3.2. The applicant shall provide the power of attorney confirming its powers to the Ministry of Health.

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