RESOLUTION OF THE CABINET OF MINISTERS OF THE AZERBAIJAN REPUBLIC

of September 25, 2007 No. 141

About approval of the Import procedure to the Azerbaijan Republic of medicines in the humanitarian purposes

For the purpose of providing Item 1.4 of the Presidential decree of the Azerbaijan Republic of February 6, 2007 "About application of the Law of the Azerbaijan Republic "About medicines" the Cabinet of Ministers of the Azerbaijan Republic decides No. 528:

1. Approve "Import procedure to the Azerbaijan Republic of medicines in the humanitarian purposes" 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 September 25, 2007, No. 141

Import procedure to the Azerbaijan Republic of medicines in the humanitarian purposes

1. This Procedure is prepared based on Item 1.4 of the Presidential decree of the Azerbaijan Republic of February 6, 2007 No. 528 and establishes import procedure to the Azerbaijan Republic of medicines in the humanitarian purposes.

2. Import on the territory of the Azerbaijan Republic of medicines in the humanitarian purposes is performed based on the conclusion of the Ministry of Health of the Azerbaijan Republic.

Import to the country in the humanitarian purposes of the medicines which did not undergo state registration in the Azerbaijan Republic is allowed in the presence of the documents confirming quality provided by their producer.

3. Import in the humanitarian purposes to the Azerbaijan Republic of medicines which quality is not guaranteed by the Ministry of Health of the Azerbaijan Republic is prohibited.

4. In case of epidemics, natural disasters and other emergency situations import of the unregistered medicines in the Azerbaijan Republic for the humanitarian purposes is allowed according to the decision of the Cabinet of Ministers of the Azerbaijan Republic in the presence of the documents confirming their registration and use in the manufacturing countries.

5. For receipt of the conclusion for import of medicines from foreign countries in the humanitarian purposes legal entities and business owners or the humanitarian organizations bringing these goods (further - applicants) shall provide to the Ministry of Health of the Azerbaijan Republic originals and according to one copy of the following documents:

5.1. for medicines (except for the medical means used for the purpose of diagnostics and treatment of diseases):

* the documents confirming quality provided by producer of the medicines imported from foreign countries in the humanitarian purposes and which did not undergo state registration;

* the statement for receipt of the conclusion for import of the medicines imported from foreign countries in the humanitarian purposes;

* agreement on humanitarian assistance or charitable letter;

* the specification with indication of names of the medicines (which are not patented trade and international), the manufacturing country, producer company, dose of medicines, dosage form, quantity, expiration date and cost (the specification shall be approved by the signature of the head of the applicant who is the legal entity, and its seal, the signature of the applicant who is the business owner);

* the distribution plan with indication of the list of the legal entities and business owners having the right to occupation medical activities to which the humanitarian aid will be provided;

* instructions for use of medicines;

* the documents confirming quality of medicines for each group of imported goods.

5.2. For the medical means used for the purpose of diagnostics and treatment of diseases (medical devices, products, things and materials, tools, the equipment, medical reactants and optical accessories) (further - medical means):

* the statement for receipt of the conclusion for import of the medicines imported from foreign countries in the humanitarian purposes;

* agreement on humanitarian assistance or charitable letter;

* the specification with indication of names of medical means, the manufacturing country, producer company, quantity, term of release, expiration date and cost (the specification shall be approved by the signature of the head of the applicant who is the legal entity, and its seal, the signature of the applicant who is the business owner);

* technical data sheet or instruction for use of medical means;

* the documents confirming quality of medical means;

* the distribution plan with indication of the list of the legal entities and business owners having the right to occupation medical activities to which the humanitarian aid will be provided.

6. Originals of the documents specified in Item 5 of this Procedure return to applicants, and copies - are stored in the Ministry of Health of the Azerbaijan Republic.

7. Copies of documents which originals are provided in foreign languages shall be translated into Azerbaijani and are notarially certified.

8. The remaining balance of expiration date of the medicines imported on the territory of the Azerbaijan Republic from foreign countries in the humanitarian purposes shall be:

* at least two years - for medicines with expiration date five years;

* at least one year - for medicines and medical sterile means with expiration date less than five years.

Useful life of the medical means arriving on the territory of the Azerbaijan Republic from foreign countries in the humanitarian purposes shall be no more than 5 years from the moment of their production.

The terms specified in the first and in the second parts of this Item can be changed by the Ministry of Health of the Azerbaijan Republic drawing the conclusion for import of the medicinal and medical means imported from foreign countries in the humanitarian purposes.

9. On marking of each packed container (container) not patented trade and international names, number of series, dosage form, the name of the producer, the manufacturing country, the number of container in container, storage conditions and expiration date shall be noted.

Medicines shall be packed according to rules of international carriages, each numbered cardboard box on which not patented trade and international names, dosage form, quantity, number of series, expiration date, amount, weight and storage conditions are specified shall be followed by detailed packaging leaf with indication of its structure. In one packaging medicines with other means shall not mix up.

10. The Ministry of Health of the Azerbaijan Republic draws the conclusion for import of the medicines imported from foreign countries in the humanitarian purposes based on results of examination of the submitted documents.

11. The Ministry of Health of the Azerbaijan Republic draws the negative conclusion on import to the territory of the Azerbaijan Republic of medicines in the humanitarian purposes in the following cases:

11.1. in case of non-presentation of the documents established by this Procedure;

11.2. in case of detection of discrepancies in the submitted documents;

11.3. in case of not passing by medicine of state registration in the Azerbaijan Republic;

11.4. in case of identification of counterfeit or illegal production of the medicines imported in the humanitarian purposes;

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