Document from CIS Legislation database © 2003-2019 SojuzPravoInform LLC

It is registered

in the Ministry of Justice

Republic of Tajikistan

of August 1, 2006 No. 227

Approved by the Order of the Ministry of Health of the Republic of Tajikistan of January 6, 2006 No. 3

Regulations on procedure for conducting checks of pharmaceutical activities pharmaceutical and treatment and prevention facilities of the Republic of Tajikistan

1. Regulations on procedure for inspection of pharmaceutical activities pharmaceutical and treatment and prevention facilities of the Republic of Tajikistan developed according to 4 and 5 Items of the Order of the Government of the Republic of Tajikistan of 29.06.2001 for No. 321 "About the Ministry of Health of the Republic of Tajikistan" and Chapters 5 and 17 of the Order of the Government of the Republic of Tajikistan of 01.09.2005 for No. 337 "About approval of regulations on features of licensing of separate types of activity"

2. The present of the Provision regulates procedure for inspection of pharmaceutical activities pharmaceutical and treatment and prevention facilities of the Republic of Tajikistan irrespective of patterns of ownership of departmental subordination.

3. Main objective of check of pharmaceutical activities is control of execution of procedure and requirements of the existing regulatory legal acts of the Republic of Tajikistan about pharmaceutical activities, about circulation of medicines and medical goods, providing the population of the country with safe high-quality and highly effective medicines.

4. Check of pharmaceutical activities pharmaceutical and treatment and prevention facilities of the Republic of Tajikistan is carried out by the State center of examination of drugs under the Ministry of Health of the Republic of Tajikistan.

5. Check of everyone, type of pharmaceutical activities on which, it is issued the license shall no more once in two years is carried out.

Additional inspection can be carried out in cases:

- in case of counter check.

- if necessary perform based on the appeal of law enforcement and other agencies.

- for the purpose of recovery of action of the license after elimination early the revealed violations and shortcomings.

6. The basis and procedure for conducting checks the right and obligations of the checking persons, and owners of licenses is determined in compliance in Chapter 14 of the Order of the Government of the Republic of Tajikistan of 01.09.2005 for No. 337 "About approval of regulations on features of licensing of separate types of activity".

7. The inspector has the right to check execution of requirements and procedure for circulation of medicines, medical goods and products of treatment-and-prophylactic food and cosmetics in pharmaceutical and treatment-and-prophylactic and other organizations in the procedure established by the legislation of the Republic of Tajikistan and in the absence of quality certificates or receipt documents to withdraw necessary quantity of samples for the purpose of the laboratory analysis.

8. In case of the wrong storage or doubt in quality of medicines, the inspector has the right to withdraw necessary quantity for the purpose of the laboratory analysis.

9. The inspector has the right to withdraw from turnover medicines and medical goods in the following cases:

- if medicines it is not registered in the Republic of Tajikistan.

- if it is necessary in case of elimination of danger of harm to health of the population.

- if quality of medicines does not conform to requirements of the specifications and technical documentation.

- if the expiration date medicine expired.

10. The inspector shall be the citizen of the Republic of Tajikistan, have the higher pharmaceutical education (years of service at least 5 years), and also not to have private interest in activities of pharmaceutical organizations.

11. In necessary cases check of pharmaceutical activities can be carried out in case of receipt of the license for the purpose of issue of the certificate of the room.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info

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