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The document ceased to be valid since  April 3, 2015 according to Item 1 of the Order of the Ministry of Health of Ukraine of  March 3, 2015 No. 108

Registered by the

Ministry of Justice of Ukraine

July 8, 2004

No. 852/9451

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of June 15, 2004 No. 301

About approval of the Procedure for the organization and conducting examination and coordination of the specifications and technical documentation on production of medicines

(as amended on 06-09-2011)

According to the Regulations on Public service of medicines and products of medical appointment approved by the resolution of the Cabinet of Ministers of Ukraine of 02.06.2003 N 789 (with changes), the List of documents which are enclosed to the application for licensing for separate type of economic activity, the approved resolution of the Cabinet of Ministers of Ukraine of 04.07.2001 N 756 (with changes), Licensed conditions of implementation of economic activity on production of medicines, wholesale, retail trade the medicines approved by the general order of the State committee of Ukraine concerning regulatory policy and entrepreneurship, the Ministry of Health of Ukraine of 12.01.2001 N 3/8, Procedure for involvement of experts, the expert organizations registered in the Ministry of Justice of Ukraine 26.01.2001 for N 80/5271, for consideration and permission of questions belonging to the powers of Public service of medicines and products of medical appointment approved by the order of the Ministry of Health of 11.02.2004 of N 79, registered in the Ministry of Justice of Ukraine of 24.02.2004 for N 243/8842 PRIKAZYVAYU:

1. Approve the Procedure for the organization and conducting examination and coordination of the specifications and technical documentation on production of medicines it (is applied).

2. To the manager of the sector of standardization and examinations of Public service of medicines and products of medical appointment Shakiny T. M. provide provision of this order in accordance with the established procedure on state registration in the Ministry of Justice and its publication in mass media.

3. To impose control of execution of this order on the deputy minister - the chairman of Public service of medicines and products of medical appointment M. F. Pasichnik.

 

Minister A. V. Pidayev

Approved by the Order of the Ministry of Health of Ukraine of June 15, 2004, No. 301

Procedure for the organization and conducting examination and coordination of the specifications and technical documentation on production of medicines

1. General provisions

1.1. This Procedure is developed according to Regulations on Public service of Ukraine on the medicines approved by the Presidential decree of Ukraine of 08.04.2011 No. 440, Procedure for involvement of experts, the expert organizations for consideration and permission of the questions relating to powers Public service of Ukraine on the medicines approved by the order of the Ministry of Health of 11.02.2004 of N 79, registered in the Ministry of Justice of Ukraine of 24.02.2004 for N243/8842.

1.2. The procedure extends to the specifications and technical documentation on production of medicines.

1.3. Coordinates the specifications and technical documentation on production of medicines Public service of Ukraine on medicines (further - Gosleksluzhba of Ukraine).

2. Terms and determinations

In this Procedure terms are used in such value:

2.1. The specifications and technical documentation on production of medicines (further - the specifications and technical documentation) - technical, production schedules (further - regulations), the file of production site (in the presence) which is equated to the technical regulation, the materials containing data on technology, technological methods, technical means, regulations and standard rates of production of medicine which are equated to production schedules.

2.2. Changes to regulations, the file of production site, other specifications and technical documentation (further - changes) - the changes offered by the applicant to technical, production schedules, the file of production site (in the presence), other specifications and technical documentation.

2.3 Examination of regulations, file of production site, other specifications and technical documentation (further - examination) - the activities consisting in studying of the provided materials concerning the production technology of medicine for the purpose of reasons for the conclusion concerning providing in conditions of production of reconstruction of pharmaceutical development of medicine and ensuring its quality according to requirements of the analytical regulating documentation and for the purpose of preparation of the conclusions concerning coordination of regulations.

2.4 Experts (the expert organizations) are domestic and foreign scientists, specialists and experts, advisory councils, groups of experts, temporary on-stage performance groups, the specialized expert organizations, the companies, research institutions, scientific expert centers, higher educational institutions which are involved in conducting examination in accordance with the established procedure.

3. Conducting examination of regulations, other specifications and technical documentation and/or changes to regulations, other specifications and technical documentation

3.1. The drafts of regulations, other specifications and technical documentation and/or changes to regulations, other specifications and technical documentation arriving in Gosleksluzhbu of Ukraine are subject to examination which is organized by Gosleksluzhba of Ukraine.

The business entity which intends to obtain the license for production of medicines personally or through person authorized in accordance with the established procedure together with accompanying leaf submits drafts of regulations, other specifications and technical documentation to Gosleksluzhbu of Ukraine.

3.2. For ensuring proper examination of drafts of regulations, other specifications and technical documentation and/or changes to regulations, other specifications and technical documentation is attached:

- copy of the certificate of conformity of production of medicine to requirements of proper production practice (NVP, GMP) (in the presence);

- standards or other documents of system of standardization of the company on which there is reference in the specified projects (for consideration of the draft of the technical regulation, the file of production site (in the presence));

- the draft copy or the existing analytical regulating documentation on the corresponding medicine (for consideration of the project of production schedules, other specifications and technical documentation);

- copies of regulations, other specifications and technical documentation to which changes are developed, materials concerning the reason of modification, the copy acting or the draft of the analytical regulating documentation, the file of production site (in the presence) on the corresponding medicine (for consideration of changes).

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