RESOLUTION OF THE CABINET OF MINISTERS OF THE AZERBAIJAN REPUBLIC

of July 25, 2007 No. 116

About approval of the Procedure for import by research establishments to the Azerbaijan Republic of medicines for the purpose of their production, research of quality, safety and efficiency

For the purpose of ensuring execution of Item 1.5 of the Presidential decree of the Azerbaijan Republic "About application of the Law of the Azerbaijan Republic "About medicines" of February 6, 2007 528, the Cabinet of Ministers of the Azerbaijan Republic decides No.:

1. Approve "Procedure for import by research establishments to the Azerbaijan Republic of medicines for the purpose of their production, research of quality, safety and efficiency" it (is applied).

2. This resolution becomes effective from the date of signing.

Approved by the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of July 25, 2007, No. 116

Procedure for import by research establishments to the Azerbaijan Republic of medicines for the purpose of their production, research of quality, safety and efficiency

1. This Procedure is prepared according to Item 1.5 of the Presidential decree of the Azerbaijan Republic "About application of the Law of the Azerbaijan Republic "About medicines" of February 6, 2007 No. 528 and establishes procedure for import by research establishments to the territory of the republic of the medicines which are not included in the state register (further - the state register) medicines for the purpose of their production, research of quality, safety and efficiency and their quantity.

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

2. Import by research establishments to the territory of the republic of the medicines which are not included in the state register for the purpose of their production, research of quality, safety and efficiency is performed based on the permission issued by the Ministry of Health of the Azerbaijan Republic or its authorized structure (further - the Ministry of Health).

3. For import by research establishments to the territory of the republic of the medicines which are not included in the state register for the purpose of their production, research of quality, safety and efficiency the manufacturing company (further - the applicant) files petition in the Ministry of Health.

3.1. The trade name of medicine, not patented international name, pharmakoterapevtichesky group, dosage form and dose, standard packaging, total quantity of packagings, the name of the producer and the address, the manufacturing country, serial number, the expiration date and storage conditions which is not included in the state register of medicine are specified in the statement the import purpose to the Azerbaijan Republic.

3.2. The following documents are enclosed to the application:

* the license for production granted by authority of the manufacturing country;

* the quality certificate issued on each series of medicine;

* agreement on approval of the applicant with the relevant research establishment of the Azerbaijan Republic;

* the report on any research or testing, carried out on medicine (in the presence);

* the protocol describing the tasks facing scientific research, preclinical researches and clinical testing, methodology, the procedure, statistical aspects.

4. The documents submitted by the applicant pass the initial examination in the Ministry of Health and together with the corresponding conclusion are represented to Pharmacological and pharmacopoeian advisory council of the Ministry of Health (further - Advisory council).

5. Based on the conclusion by results of primary examination the Advisory council makes the decision on feasibility of carrying out scientific research, preclinical researches and clinical testing.

6. If feasibility of carrying out scientific research, preclinical researches and clinical testing is acknowledged, the quantity required for carrying out the specified testing of the medicines which are not included in the state register is determined by the decision of Advisory council.

7. The Ministry of Health based on the decision of Advisory council on feasibility of carrying out scientific research, preclinical researches and clinical testing issues the import permit of the medicines which are not included in the state register in the quantity required for carrying out scientific research, preclinical researches and clinical testing.

8. The customs clearance on import by research establishments to the territory of the republic of the medicines which are not included in the state register for the purpose of production, research of quality, safety and efficiency of medicines is performed according to the legislation of the Azerbaijan Republic.

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