DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of September 7, 2018 No. 151

About approval of the Management on creation of the regulating document on quality of medicine

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, articles 4 and 13 of the Agreement on the single principles and rules of drug circulation within Eurasian economic soyuzaot on December 23, 2014 the Board of the Eurasian economic commission solved:

1. Approve the enclosed Management on creation of the regulating document on quality of medicine.

2. This Decision becomes effective after 6 months from the date of its official publication.

Approved by the Decision of Board of the Eurasian economic commission of September 7, 2018 No. 151

Management on creation of the regulating document on quality of medicine

I. General provisions

1. The present manual is developed taking into account appendix No. 3 to the 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 (further - Rules), and establishes procedure for creation and execution of the regulating document on quality of medicine (further - the regulating document on quality).

2. The present manual extends to medicines for medical application irrespective of the nature of their active ingredients.

Concerning active pharmaceutical substance creation of the regulating document on quality is not required.

3. The regulating document on quality based on the carried-out expertize of medicine establishes requirements to quality control of medicine and contains the specification and the description of techniques of testing or the reference to the relevant pharmacopoeian articles of the Pharmacopoeia of the Eurasian Economic Union approved by the Decision of Board of the Eurasian economic commission of August 11, 2020 No. 100 (further - the Pharmacopoeia of the Union), and in case of the address of medicine only in the territory of the reference state - on the relevant pharmacopoeian articles of pharmacopeia of the reference state or the pharmacopeias allowed for use by the legislation of the reference state in case of compliance of requirements of pharmacopeias also reduction of references to pharmacopoeian Articles of the Pharmacopoeia of the Union is allowed. In case of lack of the relevant pharmacopoeian article of the Pharmacopoeia of the Union in the regulating document on quality the data provided by the subitem "v" of Item 14 and Item 15 of the present manual are specified.

4. The regulating document on quality affirms authorized body of the reference state. Authorized bodies of the states of recognition (in the presence) in case of registration, registration confirmation (re-registration), modification of the registration file of medicine and reduction of the registration file of medicine in compliance (further - the Union) will approve the regulating document on quality in the edition approved by authorized body of the reference state with requirements of the Eurasian Economic Union. The regulating document on quality is intended for quality control of medicine during the post-registration period in the territories of state members of the Union (further - state members).

5. If changes in the registration file of medicine involve need of modification of the regulating document on quality, corresponding changes on quality are made to the regulating document according to Item 32 of the present manual.

6. The regulating document on quality contains the data on medicine included in Sections 3.2.P. 1, 3.2.P.5. 1, 3.2.P.5. 2, 3.2.P.7 and 3.2.P.8.1 of the module 3 registration files of medicine (according to appendix No. 4 to Rules), and the reference to Section 1.3.2 of the module of 1 registration file of medicine which are used by control laboratories of state members for control of quality of medicines. The data containing in the module 3 registration files of medicine have paramount value. The data containing in the regulating document on quality shall not contradict the data containing in the module 3 registration files of medicine. Inclusion of additional data in the regulating document on quality according to requirements of the Pharmacopoeia of the Union is allowed.

7. Specifications on the active pharmaceutical substances received by chemical synthesis (Section 3.2.S.4.1 of the module 3 registration files of medicine), on the medicines containing them (Section 3.2.P.5.1 of the module 3 registration files of medicine), and also (when applicable) specifications on the reproduced medicines are constituted according to requirements according to appendix No. 1.

8. Requirements to creation of specifications on separate groups of medicines (for example, biotechnological, radio pharmaceutical, etc.) and the active pharmaceutical substances which are part of medicines of such groups are determined by the relevant acts of bodies of the Union in the field of drug circulation.

9. Concerning medicines in the form of firm dosage forms for intake, liquid dosage forms the requirements provided by appendix No. 1 to the present manual are applied to intake, and also medicines for parenteral use (small and big amounts). General approach to creation of specifications on the specified dosage forms is allowed to be applied in case of creation of specifications on other dosage forms taking into account requirements of the relevant acts of bodies of the Union in the field of drug circulation.

II. Structure of the regulating document on quality

10. The structure of the regulating document on quality shall correspond to appendix No. 3 to Rules and keep Sections in the following order:

the title page in form according to appendix No. 2;

composition of medicine;

specification;

description of techniques of testing;

description of packaging;

marking;

storage conditions;

period of validity (storage duration).

It is allowed that the regulating document on quality contained also notes (in need of refining or explanation of the data provided in the specified Sections).

1. Title page

11. In the form of the title page of the regulating document on quality are specified:

a) all trade names of medicine approved by authorized body of state member and included or offered for inclusion in the registration certificate and dosage form according to the Nomenclature of dosage forms approved by the Decision of Board of the Eurasian economic commission of December 22, 2015 No. 172;

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