Unofficial transfer (c) Soyuzpravoinform LLC

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of July 6, 2022 No. 1169

About approval of the Procedure for test of compliance of material and technical resources, qualified personnel, and also conditions on control of quality of medicines which will be made and/or be imported on the territory of Ukraine before licensing for implementation of economic activity on production of medicines, wholesale, retail trade by medicines, import of medicines (except active pharmaceutical ingredients)

According to Articles 10, 17, 19 Laws of Ukraine "About medicines", to Item 10 parts one of article 7 of the Law of Ukraine "About licensing of types of economic activity", to Item 10 of Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of the medicines (except active pharmaceutical ingredients) approved by the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929, to Item 8 of the Regulations on the Ministry of Health of Ukraine approved by the resolution of the Cabinet of Ministers of Ukraine of March 25, 2015 No. 267 (in edition of the resolution of the Cabinet of Ministers of Ukraine of January 24, 2020 to No. 90), I ORDER:

1. Approve the Procedure for test of compliance of material and technical resources, qualified personnel, and also conditions concerning control of quality of medicines which will be made and/or be imported on the territory of Ukraine before licensing for implementation of economic activity on production of medicines, wholesale, retail trade by medicines, import of medicines (except active pharmaceutical ingredients) which is applied.

2. To management of provision of medicines (Zadvornykh I. S.) provide submission of this order in the procedure established by the legislation on state registration in the Ministry of Justice of Ukraine.

3. To impose control of execution of this order on the First Deputy Minister Komaridu A. A.

4. This order becomes effective on January 1, 2024, but not earlier than day of its official publication.

Approved by the Order of the Ministry of Health of Ukraine of July 6, 2022, No. 1169

Procedure for test of compliance of material and technical resources, qualified personnel, and also conditions on control of quality of medicines which will be made and/or be imported on the territory of Ukraine before licensing for implementation of economic activity on production of medicines, wholesale, retail trade by medicines, import of medicines (except active pharmaceutical ingredients)

I. General provisions

1. This Procedure is developed according to Articles 10, of 17, 19 Laws of Ukraine "About medicines", Item 10 parts one of article 7 of the Law of Ukraine "About licensing of types of economic activity", Item 10 of Licensed conditions of implementation of economic activity on production of medicines, wholesale and retail trade by medicines, import of the medicines (except active pharmaceutical ingredients) approved by the resolution of the Cabinet of Ministers of Ukraine of November 30, 2016 No. 929.

2. This Procedure is obligatory for accomplishment by subjects of managing who intend to obtain the license for implementation of economic activity on production of medicines, wholesale, retail trade by medicines, to import of medicines (except active pharmaceutical ingredients), Public service of Ukraine on medicines and control of drugs and its territorial authorities.

3. In this Procedure terms are used in such values:

the act - the document constituted by officials of Gosleksluzhby and/or its territorial authority by results of check of compliance of material and technical resources, qualified personnel, and also conditions concerning control of quality of medicines which will be made and/or be imported on the territory of Ukraine before licensing for implementation of economic activity on production of medicines, wholesale, retail trade by medicines, import of medicines processed in the procedure established by the legislation (except active pharmaceutical ingredients);

refusal of the subject of managing in conducting check - preventing from the subject of managing in access for officials Gosleksluzhby and/or its territorial authority on its territory and/or to buildings, constructions, rooms of the subject of managing which are used for implementation of economic activity on production of medicines wholesale, retail trade by medicines, import of medicines (except active pharmaceutical ingredients), not appointment as the subject of managing of person authorized by it which has the right to represent the subject of managing during conducting check in case of absence of the head of the subject of managing (legal entity) or the subject of managing - physical person entrepreneur, refusal in provision of documents, information concerning check subject upon the demand of officials of Gosleksluzhby and/or its territorial authority;

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