ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of December 17, 2008 No. 754

About approval of procedures for conducting examination of registration materials on medicines which are made according to the approved copy-books, and developments and approvals of copy-books on traditional medicines

In pursuance of the Law of Ukraine "About medicines" and the paragraph of the eighth Item 3 of the Procedure for state registration (re-registration) of medicines approved by the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376, for the purpose of enhancement of the procedure of state registration of medicines which are made according to the approved Ministry of Health (further - MZ) to copy-books, procedures of development and approval of copy-books on traditional medicines of PRIKAZYVAYU:

1. Approve the Procedure for conducting examination of registration materials on medicines which are made according to the approved copy-books it (is applied).

2. Approve the Procedure for development and approval of copy-books on traditional medicines it (is applied).

3. To the director of GP "State Pharmacological Center" of the Ministry of Health of Ukraine Chumak V. T. provide:

3.1. The organization of observance of requirements of these Procedures when conducting examination of registration materials on medicines which are made according to the copy-books approved by MZ, and in case of development and approval of copy-books on traditional medicines.

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

4. To impose control over the implementation of this order on the deputy minister Rybchuk V. O.

Approved by the Order of the Ministry of Health of Ukraine of December 17, 2008, No. 754

Procedure for conducting examination of registration materials on medicines which are made according to the approved copy-books

Ceased to be valid according to the Order of the Ministry of Health of Ukraine of 04.01.2013 No. 3

Approved by the Order of the Ministry of Health of Ukraine of December 17, 2008, No. 754

Procedure for development and approval of copy-books on traditional medicines

I. General provisions

1.1. This Procedure is directed to the organization of accomplishment of the Law of Ukraine "About medicines" and the paragraph of the 8th Item 3 of the Procedure for state registration (re-registration) of medicines and the amount of the collection for their state registration (re-registration) approved by the resolution of the Cabinet of Ministers of Ukraine of 26.05.2005 No. 376, for development of copy-books on traditional medicines for the purpose of their examination and approval.

1.2. The procedure extends to the medicines included in the List of medicines which are made according to the approved copy-books (further - the List).

II. Determination of terms

In this Procedure the terms established according to the procedure of conducting examination of registration materials on medicines which are made according to the approved copy-books, and the Procedure for conducting examination of materials on medicines which go for state registration (re-registration), and also examinations of materials about modification of registration materials during action of the registration certificate approved by the order of the Ministry of Health of Ukraine (further - MZ) of 26.08.2005 No. 426, registered in the Ministry of Justice of Ukraine 19.09.2005 for No. 1069/11349 are used.

III. Procedure for development, examination and approval of copy-book on traditional medicine

3.1. Development of copy-book on traditional medicine is performed jointly by GP "State Pharmacological Center" of MZ of Ukraine (further - the Center) and GP "Scientific and Expert Pharmakopeyny Center" of MZ of Ukraine (further - the Pharmakopeyny center).

3.2. The copy-book shall include the following Sections: "Structure", "Production technology", "Acting and excipients", "The specification of ready medicine", "Control methods" and "The instruction for medical application".

3.2.1. Information concerning composition of medicine which is registered in Ukraine shall be provided in the Section "Structure" and it is made within at least 10 years and which includes active ingredient with well studied medical application.

3.2.2. In the Section "Production technology" the detailed information concerning all stages of engineering procedure with mark of points of control shall be provided in production process.

3.2.3. In the Section "Acting and Excipients" references to the State Pharmacopoeia of Ukraine (further GFU), and in case of absence - the specification on acting and excipients shall be given.

3.2.4. All indicators of quality regulated by GFU shall be given in the Section "Specification of Ready Medicine". Admissible borders of indicators of quality shall meet the requirements of GFU.

3.2.5. The detailed information concerning analysis methods taking into account requirements of GFU, the existing regulatory legal acts, normative and technical documents MZ and the scientific and technical production rate and the analysis shall be provided in the Section "Control methods".

3.2.6. The instruction approved by MZ shall be provided in the Section "The Instruction for Medical Application".

3.3. Specialists of MZ can be involved in conducting examination of copy-books.

3.4. By results of examination of copy-book the Center constitutes the conclusions concerning compliance of the provided materials to the established requirements and recommends or does not recommend this copy-book for approval.

3.5. The order MZ carries out approval of copy-book.

3.6. After approval the copy-book on traditional medicine is brought in the List, access to which is free and which is posted on the website of the Ministry of Health.

3.7. The Center and the Pharmakopeyny center is responsible for forming and updating of the List.

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