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DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of December 29, 2015 №178

About Rules of determination of categories of the medicines released without recipe and according to the recipe

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, articles 3 and 4of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 30 of appendix № 2 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 №98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 №108 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union" the Board of the Eurasian economic commission decided:

1. Approve the enclosed Rules of determination of categories of the medicines released without recipe and according to the recipe.

2. This Decision becomes effective after 30 calendar days from the effective date of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 or from the effective date the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 depending on what date is later, but not earlier than after 30 calendar days from the date of official publication of this Decision.

Chairman of Board of the Eurasian economic commission

V. Khristenko

Appendix

to the Decision of Board of the Eurasian economic commission of December 29, 2015 №178

Rules of determination of categories of the medicines released without recipe and according to the recipe

I. General provisions

1. These rules are developed according to the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and determine: procedure and criteria of reference of medicine to category of the medicines released without recipe (further - OTC medicines) or the medicines released according to the recipe (further - prescription medicines); requirements to the data represented by the holder of the registration certificate in case of modification of the registration file of medicine for the purpose of change of category of its leave.

2. These rules are applied by the bodies of state members of the Union (further respectively state members, the Union) authorized in the field of drug circulation (further - authorized bodies), for the purpose of assistance to process of harmonization of the legislation of state members regarding determination of categories of the medicines released without recipe and according to the recipe.

3. These rules are applied by holders of registration certificates in case of the registration, registration confirmation (re-registration) and modification requiring examination of the expected advantage to possible risk of the registration file of medicine.

4. These rules extend to the medicines registered in state members according to the rules of registration and examination of medicines for medical application approved by the Eurasian economic commission (further - the Commission).

5. Reference of medicine to prescription or nonprescription medicines is performed in case of medicine registration. Change of category of leave of medicine is possible in case of registration confirmation (re-registration) and the modification requiring examination of the expected advantage to possible risk of the registration file of medicine.

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

"the medicines released without recipe" - medicines which leave to the patient is performed without presentation to the worker of drugstore by the patient of the recipe;

"the medicines released according to the recipe" - medicines which leave to the patient is performed only after sight to the worker of drugstore by the patient of the recipe which is written out according to the rules established by the legislation of state members;

"limited procedure for leave" - the medicine leave performed according to special requirements only in healthcare institutions without leave to patients through drugstores;

"special prescription procedure for leave" - the medicine leave to the patient performed only after sight to the worker of drugstore by the patient of the recipe which is written out on the special form and drawn up in a special way according to the rules established by the legislation of state members.

II. Rules of determination of categories of leave of medicines

1. Rule 1

7. In case of medicine registration, in case of registration confirmation (re-registration) and entering into the registration file of medicine of changes (if such changes require examination of the expected advantage in comparison with possible risk) authorized bodies shall determine medicine belonging to one of the following categories of leave:

a) prescription medicines;

b) OTC medicines.

8. Requirements of Item 9 of these rules are applied to determination of belonging of medicine to category of prescription medicines. Authorized bodies can establish (to allocate) special subcategories of prescription medicines. At the same time it is necessary to adhere to the following gradation:

a) prescription medicines with regular prescription issue;

b) the prescription medicines which are subject to special prescription procedure for leave;

c) the prescription medicines which are subject to limited procedure for leave according to the special requirement and applied in specially stipulated purposes.

2. Rule 2

9. Medicines are subject to reference to category of prescription medicines if they:

a) even in case of the correct use, but without medical observation, can do direct or indirect harm to health of the person;

b) are often applied incorrectly and, as a result, can do direct or indirect harm to health of the person;

c) contain substances or connections which action and (or) undesirable reactions on which are insufficiently studied (are subject to further studying);

d) are entered parenterally (as a rule).

10. If authorized bodies provide establishment of subcategory of the prescription medicines which are subject to special prescription procedure for leave, they shall take medicine compliance to the following criteria into account:

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