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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of December 7, 2021 No. 169

About approval of requirements to research of stability of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) and medicinal vegetable drugs

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 2 of Article 3 and article 6 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 the Board of the Eurasian economic commission solved:

1. Approve the enclosed Requirements to research of stability of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) and medicinal vegetable drugs.

2. This Decision becomes effective after 12 months from the date of its official publication.

Chairman of Board of the Eurasian economic commission

M. Myasnikovich

Approved by the Decision of Board of the Eurasian economic commission of December 7, 2021 No. 169

Requirements to research of stability of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) and medicinal vegetable drugs

I. General provisions

1. These Requirements are applied when planning and carrying out researches of stability of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) and medicinal vegetable drugs, and also in case of creation of the registration file of medicinal vegetable drugs.

2. These Requirements establish single approaches to carrying out researches of stability of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) and medicinal vegetable drugs and contain the description of researches of stability of mixes of vegetable pharmaceutical substance with vitamins and (or) mineral components. At the same time quality of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) and medicinal vegetable drugs, specifications and documentation on each vitamin and mineral component shall conform to the established requirements.

3. These Requirements do not extend to the medicines containing separate components or mix of components with accurately established chemical composition as they are not considered as medicinal vegetable drugs.

4. These Requirements are developed in addition to the Rules of proper production practice of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 77, to Rules of registration and examination of medicines for medical application, approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78, and to the Requirements to research of stability of medicines and pharmaceutical substances approved by the Decision of Board of the Eurasian economic commission of May 10, 2018 No. 69, regarding the provisions concerning vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) and medicinal vegetable drugs.

5. These Requirements are applied taking into account provisions of the acts of the Eurasian economic commission (further - the Commission) establishing quality requirements of medicinal vegetable drugs and also to the choice of tests and eligibility criterions to creation of specifications on medicinal vegetable raw materials, vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) and medicinal vegetable drugs.

6. The purposes of carrying out researches of stability are data acquisition about change of quality of vegetable pharmaceutical substance (drugs on the basis of medicinal vegetable raw materials) or medicinal vegetable drug eventually under the influence of different factors of the environment (temperature, humidity and light), and also establishment of storage conditions and period of validity (storage duration) of medicinal vegetable drug.

II. Research of stability of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials)

7. When studying stability of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) it is necessary to consider provisions of Requirements to research of stability of medicines and pharmaceutical substances and these Requirements.

8. If the production process of medicine includes the production of vegetable pharmaceutical substance interconnected with it (drug on the basis of medicinal vegetable raw materials), then the research of stability is conducted only for ready medicinal vegetable drug.

9. If medicinal vegetable drug consists of mix of the vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) which are in multidose packaging, then when using the corresponding material of packaging of research of stability of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) are optional provided that content of such substances (drugs) in ready medicinal vegetable drug can be determined by means of the corresponding method of the analysis during all term of its validity (storage duration). In case there are data on stability of each vegetable pharmaceutical substance (drug on the basis of medicinal vegetable raw materials) entering ready dosage form and lack of interaction between such substances (drugs) is proved, we will allow alternative approach in case of which the research of stability of ready dosage form of medicinal vegetable drug can be replaced with data on stability of separate vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials).

10. Specifications on medicinal vegetable raw materials and vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) are constituted taking into account provisions of the acts of the Commission establishing requirements to the choice of tests and eligibility criterions for creation of specifications on medicinal vegetable raw materials, vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) and medicinal vegetable drugs.

11. Carrying out researches of stability of medicinal vegetable raw materials begins after 3 months from the date of its procurement. Carrying out researches of stability of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) begins after 3 months from the date of their production. At the same time in the presence of considerable degradation of vegetable pharmaceutical substances (drugs on the basis of medicinal vegetable raw materials) within the first three months the beginning of carrying out researches of stability after three months is not acceptable.

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