DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of April 12, 2024 No. 29

About modification of the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83

According to Articles 7, 10 and 12 Agreements on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Items 81 and 96 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Council of the Eurasian economic commission DECIDED:

1. Bring in the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83 "About approval of Rules of conducting pharmaceutical inspections" changes according to appendix.

2. This Decision becomes effective after 30 calendar days from the date of its official publication.

Members of council of the Eurasian economic commission:

Appendix

to the Decision of Council of the Eurasian economic commission of April 12, 2024 No. 29

The changes made to the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83

1. In the name "Edited" the word to replace with the word of "rules".

2. In word preamble "Articles 7 and 10" shall be replaced with words "Articles 7, 10 and 12", "Item 96" shall be replaced with words words "Items 81 and 96".

3. State Item 1 in the following edition:

"1. Approve enclosed:

Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper production practice of the Eurasian Economic Union;

Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper practice of pharmakonadzor of the Eurasian Economic Union.".

4. In Rules of conducting the pharmaceutical inspections approved by the specified Decision:

a) add the name with the words "on compliance to requirements of Rules of proper production practice of the Eurasian Economic Union".

b) in the paragraph the second Item 19 of figure "1 - 4" to replace with figures "5 - 7".

5. Add with Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper practice of pharmakonadzor of the Eurasian Economic Union of the following content:

"Are approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83

Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper practice of pharmakonadzor of the Eurasian Economic Union

I. General provisions

1. Requirements to the organization and functioning of system of pharmakonadzor of holders of registration certificates of medicines (further – holders of registration certificates) are determined by the Rules of proper practice of pharmakonadzor of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 87 (further – Rules of pharmakonadzor).

2. For the purpose of confirmation of observance by the holder of the registration certificate of requirements to the organization and functioning of system of pharmakonadzor and accomplishment of obligations on pharmakonadzor, the functions authorized on accomplishment and performing on pharmakonadzor bodies of state members (the expert organizations) of the Eurasian Economic Union (further respectively – authorized bodies, state members) shall carry out pharmaceutical inspections on compliance of system of pharmakonadzor of the holder of the registration certificate and other organizations attracted with the holder of the registration certificate to accomplishment of obligations on pharmakonadzor, requirements of Rules of pharmakonadzor (further respectively – inspections, the inspected object (the inspected party, the inspected organization)).

3. These rules determine requirements to:

to initiation of inspection;

to conducting inspection;

to preparation of the report on inspection of system of pharmakonadzor of the holder of the registration certificate (further – the inspection report);

to data exchange about results of inspection of system of pharmakonadzor.

Responsibility for conducting inspection and preparation of the inspection report it is assigned to pharmaceutical inspectors who are appointed by authorized body for accomplishment of inspection.

II. Determinations

4. The concepts used in these rules are applied in the values determined by the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and Rules of pharmakonadzor.

III. Procedures of initiation of inspection

1. Initiation of inspection

5. Conditions and procedure for purpose of planned and unplanned inspections are determined by Rules of pharmakonadzor. Authorized bodies will organize work on inspection of holders of registration certificates with ensuring interaction at stage of planning and conducting inspections for the purpose of minimization of duplication of the performed works and optimization of use of the available resources according to Items 179 and 180 of Rules of pharmakonadzor.

6. The procedure of initiation of inspection represents actions on the organization of inspection of system of pharmakonadzor after determination of the inspected object which are directed to planning of the forthcoming inspection and include, but are not limited to it, the following:

determination of structure of inspection team;

the notification on conducting inspection of the inspected object;

accomplishment of necessary logistic (organizational) actions;

scoping, programs, terms and venue of inspection.

These operations are performed by the authorized body responsible for conducting inspection, and if necessary include interaction with the inspected object. In case of accomplishment of inspectorate for request of authorized body of other state member accomplishment of the specified actions at this stage includes interaction with the authorized body initiating accomplishment of inspection.

2. Determination of structure of inspection team

7. Appointment of pharmaceutical inspectors and their qualification for accomplishment of inspection are determined by requirements, stipulated in Item 177 Rules of pharmakonadzor, and rules of forming of inspection teams according to the legislation of state member. Pharmaceutical inspectors shall be the representative's specialists on accomplishment and implementation of functions in pharmakonadzor of body, or persons designated according to the legislation of state member. Forming of inspection team can be performed with involvement of pharmaceutical inspectors of 2 and more authorized bodies.

Forming of inspection team and determination of the period of accomplishment of inspection shall be oriented to ensuring accomplishment of the tasks set for inspectorate for assessment of conformity of system of pharmakonadzor of the holder of the registration certificate to requirements of Rules of pharmakonadzor.

3. The notification on conducting inspection of the inspected object

8. The authorized body has the right to perform inspection of systems of pharmakonadzor of holders of registration certificates at any moment according to type and the purposes of inspection. It is in exceptional cases allowed to carry out inspections without prior notice if it is required to execute inspection of system of pharmakonadzor in case of identification of the initiating factor and in need of immediate assessment of important risk for public health (health of the population) or functioning of system of pharmakonadzor or in cases when the notification can threaten goal achievement of inspection.

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