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Ministry of Justice

Republic of Tajikistan

On September 21, 2015 No. 795

ORDER OF THE MINISTRY OF HEALTH AND SOCIAL PROTECTION OF THE REPUBLIC OF TAJIKISTAN

of August 21, 2015 No. 736

About approval of "Procedure for state registration of medicines and medical goods in the Republic of Tajikistan"

According to article 20 of the Law of the Republic of Tajikistan "About medicines and pharmaceutical activities" and based on Item 10 of the Regulations on the Ministry of Health and Social Protection of the Republic of Tajikistan approved by the Order of the Government of the Republic of Tajikistan of March 3, 2014 148, I DISPOSE No.:

1. Approve the Procedure for state registration of medicines and medical goods in the Republic of Tajikistan it (is applied).

2. (Holnazarov B. M.) to charge to the head of Service of the state supervision of pharmaceutical activities of the Republic of Tajikistan:

a) provide this order to the Ministry of Justice of the Republic of Tajikistan for state registration (term of 10 days);

b) provide works on registration of medicines and medical goods in compliance with this Procedure (term constantly);

3. Heads of treatment-and-prophylactic and pharmaceutical organizations, it is not dependent on patterns of ownership and departmental accessory, engaged in pharmaceutical activities, to oblige strictly according to requirements of this Procedure and the current legislation of the Republic of Tajikistan to provide documents for state registration of medicines and medical goods in the Republic of Tajikistan in Service of the state supervision of pharmaceutical activities of the Republic of Tajikistan (term constantly)

4. To the head of department of control, clerical work and special work of the Ministry of Health and Social Protection (to Zamonov A. K.) charge timely, bring this order to the organizations relating to this sphere.

5. This Order to enact the field of state registration and the official publication.

6. Recognize voided the Order of the Minister of Health and Social Protection of the Republic of Tajikistan of December 8, 2014, No. 1061 "About approval of the Provision "About Procedure for State Registration of Medicines and Medical Goods in the Republic of Tajikistan".

7. Control of execution of this Order to assign to the first deputy minister Bobokhodzhayeva L. S.

Minister

N. Salimzoda

Approved by the Order of the Minister of Health and Social Protection of the Republic of Tajikistan of August 21, 2015, No. 736

Procedure for state registration of medicines and medical goods in the Republic of Tajikistan

1. General provisions

1.1. This procedure regulates state registration of medicines and medical goods in the Republic of Tajikistan and is obligatory for legal entities irrespective of pattern of ownership who enable production, the realization and use of medicines and medical goods for the purpose of their registration.

1.2. The basic concepts used in this Procedure:

- state registration of medicines and medical goods - system of accounting which is determined by the admission to industrial production and medical application, medicines, the medical goods made in the Republic of Tajikistan or arriving because of its limits realized and applied in medical practice which based on expert evaluation of documentation and results of the carried-out testing are acknowledged conforming to quality requirements, efficiency and the safety for the person established in the Republic of Tajikistan;

- medicines - the substances applied to prevention, diagnostics, treatments of diseases, prevention of pregnancy received from blood, blood plasma and also bodies and tissues of the person or animal, plants, minerals, by methods of synthesis or using biological technologies;

- the reproduced (generic) medicines - the medicines which arrived in the address after expiration of exclusive patent laws on original medicines;

- the registered medicines - the medicines which passed control and clinical tests and the normative and technical examination of the Ministry of Health and Social Protection of the Republic of Tajikistan and entered in the State Register of medicines;

- medical goods - the products and materials applied in medical practice to diagnostics, treatment and prevention of diseases.

Materials (dressing, sutural, account) and products concern to them (medical, medical equipment, objects of patient care):

- Article - the standard establishing requirements to medicine, its packaging, conditions and storage durations, methods of the analysis of quality of medicine;

- the temporary pharmakopeyny Article (TPA) - the pharmakopeyny Article approved for the basis of industrial release of medicine (no more than three years);

- registration number - the specification symbol appropriated to medicine in case of state registration;

- the state Register of medicines - the regulating document containing data on the medicines permitted to production and application in medical practice;

- clinical testing - the studying of safety and (or) efficiency of the researched medicine for the person directed to identification or confirmation clinical, pharmacological and (or) phracodynamic of properties of the researched medicine and (or) carried out for the purpose of identification of its collateral reactions and (or) for the purpose of studying of its absorption, distribution, biotransformation and removal;

- collateral reactions of medicine - any adverse clinical manifestations which regardless of dose of medicine can lead to death resistant or the expressed disability and (or) disability, congenital anomaly.

2. Procedure for submission of documents and conducting examination for registration of medicines and medical goods

3. The applicant submits in authorized body the application for registration of medicines and medical goods, registration case and samples of medicine in number of 5 copies (but it is at least sufficient for 3 parallel analyses) and working standards.

4. In case products of the same firm are made in various countries, then the list of these countries shall be provided in documents or is specified in the request for registration. If the producer company guarantees product quality, made under the trademark in other countries, then it can become the basis for registration.

5. The authorized body accepts documents, samples of medicines and medical goods, carries out primary expertize of the submitted documents on compliance to their established requirements.

6. Primary expertize of the submitted documents is carried out and drawn up by the deed of conveyance for specialized examination. In case of detection of discrepancy of documents the authorized body informs the applicant of the found applicant's shortcomings.

7. In case of lack of notes to documentation submitted on registration, documents are transferred to SUE Ekspertiza i ispytaniya pharmatsevticheskoy i meditsinskoy produktsii or to independent experts for carrying out expert works. Expert works are carried out to the terms determined by the agreement.

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