DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of January 26, 2018 No. 15

About approval of Rules of proper practice of cultivation, collection, processing and storage of initial raw materials of plant origin

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 4 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 7 of the list of acts of the Eurasian economic commission on questions of regulation of the total markets of medicines and medical products within the Eurasian Economic Union for 2017 - 2019 approved by the order of Council of the Eurasian economic commission of May 17, 2017 No. 15, Council of the Eurasian economic commission solved:

1. Approve the enclosed Rules of proper practice of cultivation, collection, processing and storage of initial raw materials of plant origin.

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

Approved by the Decision of Council of the Eurasian economic commission of January 26, 2018 No. 15

Rules of proper practice of cultivation, collection, processing and storage of initial raw materials of plant origin

I. General provisions

1. These rules establish requirements to proper practice of cultivation, collection (procurement), processing and storage of initial raw materials of the plant origin intended for medical application and system of quality assurance of this practice. Production and processing of medicinal vegetable raw materials directly influences quality of active pharmaceutical substance.

2. Ensuring the reproduced quality of initial materials of plant origin in connection with complexity of component composition of the wild-growing and cultivated medicinal raw materials and limited opportunities of analytical techniques for establishment of characteristics of their components in case of cultivation, collection (procurement), processing and storage of herbs requires proper system of quality assurance.

3. Main objective of these rules is creation of the corresponding system of quality assurance of medicinal vegetable raw materials for safety of consumers of medicinal vegetable raw materials, and also in order to avoid possible pereputyvaniye of similar plants and harming the environment because of low qualification of personnel and lack of control by establishment of the corresponding quality standards of medicinal vegetable raw materials. At stages of cultivation, collection (procurement), processing and storage of medicinal vegetable raw materials in order to avoid decline in quality and for minimizing of microbiological loading it is necessary to provide compliance with law of state members of the Eurasian Economic Union (further respectively - state members, the Union) in the field of use of hygienic requirements and sanitary standards, and also careful processing of medicinal vegetable raw materials.

4. These rules extend to agricultural production of medicinal vegetable raw materials, including organic production, and procurement of wild-growing medicinal vegetable raw materials.

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

"medicinal vegetable raw materials", "herbs", "initial raw materials of plant origin" (herbal raw materials) - the fresh or dried-up plants, seaweed, mushrooms or lichens or their parts, the integral or crushed, morphological groups used for production of medicines. Some exudates (for example, arabic gum, gum) which were not exposed to special processing are also considered as medicinal vegetable raw materials. Medicinal vegetable raw materials are precisely determined by the used part of plant and the botanical name according to binomial system (sort, type), version and specifying in the botanical name of the author;

"organic production" (organic production) - form of farming within which there is conscious minimization of use of synthetic fertilizers, pesticides, regulators of growth of plants, feed additives, genetically modified organisms. In organic production the effect of crop rotation, organic fertilizers (manure, compost, etc.), different methods of processing of the soil, etc. is more actively applied to increase in productivity, providing cultural plants with elements of mineral food, pest control and weeds.

6. These rules should be applied in interrelation with part II of 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. These rules are established in addition to the requirements established in the specified Rules, requirements it is preferential to the critical production stages of medicinal vegetable raw materials necessary for ensuring proper quality.

7. These rules extend to all participants of production process from the individual entrepreneurs and subjects of managing collecting (procurement) and cultivation of medicinal vegetable raw materials to producers and distributors of medicinal vegetable raw materials. Producers and distributors of medicinal vegetable raw materials shall observe requirements of these rules, document all operations performed by them in documents (file) on series and demand observance of these rules from all participants of production process of medicinal vegetable raw materials (if other is not proved).

8. Cultivation, collection, processing and storage of medicinal vegetable raw materials shall be performed with observance of provisions of the Convention on international trade in the types of wild fauna and flora which are under the threat of destruction (SITES) and without drawing environmental damage.

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