ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of February 4, 2011 No. 65

About approval of Licensed conditions of implementation of economic activity on conversion of donor blood and its components, to production from them of medicines, except activities of banks of umbilical blood, other fabrics and cells of the person

According to the Law of Ukraine "About licensing of certain types of economic activity" and the resolution of the Cabinet of Ministers of Ukraine of 14.11.2000 "About approval of the list of bodies of licensing" I ORDER to No. 1698:

1. Approve Licensed conditions of implementation of economic activity on conversion of donor blood and its components, production from them of medicines, except activities of banks of umbilical blood, other fabrics and cells of the person which are applied.

2. To department of management and quality control of medical services (Shpak I. V.) provide:

2.1. Submission of this order in accordance with the established procedure on state registration in the Ministry of Justice of Ukraine.

2.2. The publication of this order in mass media.

3. To impose control over the implementation of this order on the deputy minister Kopytov S. M.

4. This order becomes effective since October 01, 2013.

Approved by the Order of the Ministry of Health of Ukraine of February 4, 2011 No. 65

Licensed conditions of implementation of economic activity on conversion of donor blood and its components, production from them of medicines, except activities of banks of umbilical blood, other fabrics and cells of the person

I. General provisions

1.1. Licensed conditions of implementation of economic activity on conversion of donor blood and its components, production from them of medicines, except activities of banks of umbilical blood, other fabrics and cells of the person (further - Licensed conditions),  No. 920 "About approval of the Procedure for conversion and storage of donor blood and its components, their realization and the medicines made of them", of 14.09.98 No. 1427 "About approval of the Procedure for realization out of limits of Ukraine of components of donor blood and the medicines made of donor blood and its components, and also export from Ukraine of donor blood and its components" of 14.11.2000 No. 1698 "About approval of the list of bodies of licensing" is developed according to the Laws of Ukraine "About donorship of blood and its components" and "About licensing of certain types of economic activity", resolutions of the Cabinet of Ministers of Ukraine of 16.06.98.

Terms which are used in these Licensed conditions have the following value:

the licensee - the subject of housekeeping who obtained the license for implementation of certain type of economic activity;

the license - the document of the state sample which certifies the right of the licensee to implementation of economic activity on conversion of donor blood and its components, production from them of medicines, except activities of banks of umbilical blood, other fabrics and cells of the person, on condition of accomplishment of Licensed conditions;

conversion of donor blood and its components, production from them of medicines, except activities of banks of umbilical blood, other fabrics and cells of the person, - the activities regulated by the current legislation connected with conversion of donor blood and its components, production from them of medicines which includes all stages of engineering procedure taking into account observance of special storage conditions and quality control, and also sales of products of own production.

1.2. Application forms about licensing, the List of documents which are enclosed to the application on receipt of the license of Data on material and technical resources condition, availability of normative legal documents, including regulating documents concerning standardization and about personnel availability with indication of its educational and qualification level, necessary for carrying out economic activity on conversion of donor blood and its components, production from them of medicines, except activities of banks of umbilical blood, other fabrics and cells of the person, statements for issue of the copy of the license, for renewal of the license and for issue of the duplicate of the license are given in appendices 1 - 6 to this order.

1.3. Action of Licensed conditions extends to all subjects of housekeeping registered in accordance with the established procedure irrespective of their form of business and pattern of ownership and which perform economic activity on conversion of donor blood and its components, production from them of medicines, except activities of banks of umbilical blood, other fabrics and cells of the person.

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