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DECISION OF BOARD OF THE EUROASIAN ECONOMIC COMMISSION

of May 10, 2018 No. 69

About approval of Requirements to research of stability of medicines and pharmaceutical substances

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 and Item 3 of the list of acts of the Euroasian economic commission on questions of regulation of the total markets of medicines and medical products within the Eurasian Economic Union for 2017 - 2019 (No. 15) the Board of the Euroasian economic commission solved appendix to the order of Board of the Euroasian economic commission of May 17, 2017:

1. Approve the enclosed Requirements to research of stability of medicines and pharmaceutical substances.

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

Chairman of Board of the Euroasian economic commission

T. Sargsyan

Approved by the Decision of Board of the Euroasian economic commission of May 10, 2018 No. 69

Requirements to research of stability of medicines and pharmaceutical substances

I. General provisions

1. These Requirements are developed according to the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 for the purpose of establishment of procedure for research of stability of medicines and pharmaceutical substances in state members of the Eurasian Economic Union (further respectively - state members, the Union) in addition to provisions of Rules of registration and examination of the medicines for medical application approved by the Decision of Council of the Euroasian economic commission of November 3, 2016 No. 78 (further - Rules of registration and examination), the Rules of proper production practice of the Eurasian Economic Union approved by the Decision of Council of the Euroasian economic commission of November 3, 2016 No. 77.

2. Requirements to researches of stability of biological medicines are established by the Rules of carrying out researches of biological medicines of the Eurasian Economic Union approved by the Decision of Council of the Euroasian economic commission of November 3, 2016 No. 89.

3. These Requirements are applied when planning and carrying out researches of stability of pharmaceutical substances and medicines on their basis, and also in case of creation of the registration file. At the same time biological (including biotechnological) origins these Requirements are applied to pharmaceutical substances and medicines in the part which is not contradicting requirements of Chapter 8 of Rules of carrying out researches of biological medicines of the Eurasian Economic Union. And also to the medicines received on their basis, these Requirements are applied to radio pharmaceutical, vegetable pharmaceutical substances in the part which is not contradicting requirements to the researches of stability of radio pharmaceutical and vegetable pharmaceutical substances and medicines determined by the Euroasian economic commission (further - the Commission).

4. The purposes of carrying out researches of stability are data acquisition about change of quality of pharmaceutical substance or medicine eventually under the influence of different factors of the environment (temperature, humidity and light), and also establishment of recommended storage conditions and the period prior to repeated researches of stable pharmaceutical substance, period of validity of unstable pharmaceutical substances or medicines.

II. Determinations

5. For the purposes of these Requirements concepts which mean the following are used:

"the choice of extreme options (breketing)" (bracketing) - scheduling of research of stability so that tests only with extreme (extreme) values of certain factors among in all temporary points of control used when carrying out complete researches were exposed to research. The plan assumes that stability of tests with intermediate values of factors among is equated to stability of tests with extreme values;

"this, in addition confirming stability" (supporting stability data) - data which are not the specification on stability obtained during formalized (standardly carried out according to requirements imposed to these researches) researches. Such data in addition prove analytical techniques, the offered period prior to repeated researches or period of validity, and also storage conditions;

"expiry date of the validity (storage duration)" (expiratio№date) - the date specified in marking of container of pharmaceutical substance or medicine and designating the end of the period during which (inclusive) in case of storage in the established conditions they will meet the approved specifications and after which they cannot be used;

"date of repeated researches" (re-test data) - date after which it is necessary to conduct repeatedly researches of stable pharmaceutical substance for confirmation of its compliance of the specification and, respectively, suitability for production of certain medicine;

"date of production of series" - date of accomplishment of the first transaction providing mixing of pharmaceutical substances with other ingredients of medicine. For pharmaceutical substances date of production of series initial activity date on packing and packaging is considered. For the medicines consisting of one pharmaceutical substance in primary package, initial date of filling of primary package is considered date of production;

"long-term researches" (long term testing) - research of stability of physical, chemical, biological, biopharmaceutical and microbiological characteristics of pharmaceutical substance or medicine for the purpose of determination of the period prior to repeated researches for the confirmation of earlier fixed term of the validity and (or) storage conditions specified in information on medicine;

"acceptable deviations in storage conditions" (storage conditio№tolerances) - acceptable fluctuations of temperature and relative humidity in technical means for storage in case of the formalized stability researches;

"significant change of medicine" (significant change of the drug product) - one of the following changes:

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