It is registered
Ministry of Justice of Ukraine
February 22, 2013
of February 20, 2013 No. 143
About approval of Licensed conditions of implementation of economic activity on import of medicines
1. Approve Licensed conditions of implementation of economic activity on import of medicines which are applied.
2. Determine that compliance of material and technical resources, qualifications of personnel, and also conditions concerning control of quality of medicines to requirements to import of medicines and characteristics declared in the documents filed by the applicant for receipt of the import license of medicines is confirmed by materials of scheduled inspection of observance of licensed conditions of implementation of economic activity on production of medicines or wholesale trade medicines or checks before licensing for implementation of economic activity on production of medicines or wholesale trade by medicines according to the legislation of Ukraine, and in case of not conducting such checks - check materials before licensing for implementation of economic activity on import of medicines.
3. To the head of department of medicines and medical products Konoshevich L. V. in accordance with the established procedure to provide provision of this order on state registration in the Ministry of Justice of Ukraine.
4. To impose control over the implementation of the order on Ministrarukovoditel's deputy of the device Bogachyov R. M.
Approved by the Order of the Ministry of Health of Ukraine of February 20, 2013 No. 143
1.1. These Licensed conditions are developed according to the Laws of Ukraine "About medicines", "About licensing of certain types of economic activity" and establish qualification, organizational and other requirements for implementation of economic activity on import of medicines.
1.2. Action of these Licensed conditions extends to all subjects of managing irrespective of pattern of ownership performing economic activity on import of medicines and also to physical persons - the entrepreneurs performing economic activity in the specified area (further - the subject of housekeeping).
These Licensed conditions extend to subjects of managing who import medicines for the purpose of their subsequent realization or use in production of finished pharmaceutical products.
Action of these Licensed conditions does not extend to activities for import of medicines to the territory of Ukraine according to the Laws of Ukraine "About the humanitarian assistance", "About charity and charitable organizations" and "About accomplishment of programs of Global fund for fight against AIDS, tuberculosis and malaria in Ukraine".
Action of these Licensed conditions does not extend to activities for import to the territory of Ukraine of active pharmaceutical ingredients.
1.3. Terms which are used in these Licensed conditions have such values:
import of medicines - the activities connected with import to the territory of Ukraine of the registered medicines for the purpose of their subsequent realization or use in production of finished pharmaceutical products including: storage, quality control, release of series (confirmation by the importer of the quality certificate which is issued by the producer, and issue of permission to release) and wholesale trade by the medicines specified in appendix to the license;
the importer of medicines (further - the importer) - the subject of managing registered in Ukraine (resident), which is performing economic activity on import of medicines and having the import license of medicines;
the licensee - the subject of managing who obtained the license for implementation of certain type of the economic activity which is subject to licensing;
proper production practice (Good Manufacturing Practice (GMP)) part of system of quality assurance which guarantees that medicines are constantly made and controlled according to the quality standards corresponding to their appointment and also according to requirements of the registration file or the specification of these products;
wholesale trade by medicines - activities for acquisition of medicines at producers of the medicines or other subjects of managing having the corresponding license to storage, transportation and sale of medicines from pharmaceutical warehouses (bases) to other subjects of wholesale or retail trade by medicines which obtained on it the corresponding licenses and it is direct to institutions of health care and producers of medicines;
realization - activities of subjects of managing for sales of goods (works, services);
the authorized person for the subjects of managing performing import of medicines (further - the Authorized person), - the specialist with complete higher pharmaceutical, chemical, biological or biotechnological education and length of service in at least two years in the field of production, quality control, wholesale trade or development of medicines to whom the subject of managing assigns obligations concerning functioning of system of quality assurance of medicines in case of their import (import) to the territory of Ukraine and provision of permission to release (realization) of the imported medicines.
1.4. Documents acceptance which move for receipt of the license issue, renewal, cancellation of licenses, issue of duplicates of licenses, conducting licensed cases and licensed registers, issue of orders about elimination of violations of these Licensed conditions are carried out by Public service of Ukraine on medicines (further - Gosleksluzhba of Ukraine).
1.5. For receipt of the license for implementation of economic activity on import of medicines the subject of managing submits to Gosleksluzhbu of Ukraine the application in the form given in appendix 1 to these Licensed conditions.
In case of availability at the applicant of the isolated structural divisions which will perform economic activity based on the obtained license their addresses in the place of implementation of economic activity are specified in the statement.
1.6. Documents, the stipulated in Article 10 Laws of Ukraine "About licensing of certain types of economic activity" are enclosed to the application, namely:
the copy of the file of the importer approved as the subject of managing in the form given in appendix 10 to these Licensed conditions.
The statement for licensing and documents attached to it are accepted under the list of documents, enclosed to the application for licensing in the form given in appendix 2 to these Licensed conditions which copy is issued to the applicant with mark about date of documents acceptance by Gosleksluzhboy of Ukraine and the signature of the authorized officer.
All documents submitted by the applicant are created in separate case.
1.7. The statement for licensing remains without consideration if:
the application is submitted (signed) by person which does not have on it powers;
documents are processed with violation of requirements of article 10 of the Law of Ukraine "About licensing of certain types of economic activity".
Gosleksluzhboy of Ukraine in writing with indication of the bases of leaving of the statement without consideration in the terms provided for licensing is reported to the applicant about leaving of the statement for licensing without consideration.
1.8. After elimination of the reasons which were the basis for decision making about leaving of the statement for licensing without consideration the applicant can repeatedly submit the application for licensing.
1.9. The Gosleksluzhba of Ukraine makes the decision on licensing or on refusal in its issue no later than ten working days from receipt date of the statement for licensing and documents which are enclosed to the application in time.
The basis for licensing for import of medicines is availability of the corresponding material and technical resources, qualified personnel, and also conditions concerning control of quality of medicines which will be imported on the territory of Ukraine.
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