DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 №91

About approval of the Procedure for ensuring conducting joint pharmaceutical inspections

Astana

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 1 of article 10 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 100 of appendix № 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 № 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" Council of the Eurasian economic commission decided:

1. Approve the enclosed Procedure for ensuring conducting joint pharmaceutical inspections.

2. This Decision becomes effective after 10 calendar days from the effective date of 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, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 №91

Procedure for ensuring conducting joint pharmaceutical inspections

I. General provisions

1. This Procedure is developed according to Item 1 of article 10 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 100 of appendix №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 № 98, and determines rules of ensuring carrying out with pharmaceutical inspectorates of state members of the Eurasian Economic Union (further respectively – state members, the Union) joint pharmaceutical inspections on compliance of the medicines to rules ought the practician in the sphere of drug circulation within the Union.

2. Joint pharmaceutical inspections are carried out in planned and unplanned procedure.

Joint planned pharmaceutical inspections can be carried out by pharmaceutical inspectorates of state members within cooperation and experience exchange.

Joint unplanned pharmaceutical inspections (further – unplanned inspections) are carried out by pharmaceutical inspectorates of state members for the purpose of settlement of disagreements and ensuring mutual recognition with state members of results of inspection of productions, preclinical (not clinical), clinical trials (testing) of medicines and systems of pharmacovigilance and distribution on compliance to rules ought the practician in the sphere of drug circulation within the Union.

3. Unplanned inspections are carried out concerning producers of pharmaceutical substances, bulk and finished goods, the organizations performing not clinical and clinical trials (testing) of medicines, and also distributors of medicines (further – the inspected subjects).

4. Conducting joint pharmaceutical inspection, and also preparation of the inspection report are performed according to the rules of conducting pharmaceutical inspections approved by the Eurasian economic commission, and the legislation of state member which authorized body initiated conducting such inspection.

5. Ensuring conducting planned and unplanned inspection, including payment of expenses (including traveling and other expenses), is determined according to the legislation of state members.

The expenses connected with conducting unplanned inspection can be performed at the expense of means of the inspected subject only concerning pharmaceutical inspectorate which authorized body of state member initiated conducting such inspection.

II. Organization of unplanned inspection

6. Unplanned inspection is carried out according to the recommendation of Expert committee on medicines (further – Expert committee) accepted by results of consideration of the appeal of authorized body of state member in the field of drug circulation or the inspected subject for the purpose of settlement of disagreements.

7. The pharmaceutical inspectorate initiating conducting unplanned inspection within 10 working days based on offers of other pharmaceutical inspectorates participating in conducting unplanned inspection creates inspection team and appoints the leading inspector.

The leading inspector distributes functions of members of inspection team, coordinates holding preparatory activities and in case of need in coordination with other pharmaceutical inspectorates recruits experts.

Before inclusion in structure of inspection team the involved experts sign the confidentiality agreement and nondisclosure of information obtained by them during conducting unplanned inspection.

Data on date of unplanned inspection and contact information of members of inspection team go to Expert committee.

8. Within preparation for conducting unplanned inspection the leading inspector:

a) approves with the inspected subject no later than 40 calendar days before the planned date of unplanned inspection the term of its carrying out, and also in case of need notifies on expenses on conducting such inspection;

b) sends to the pharmaceutical inspectorates participating in conducting unplanned inspection, information on agreed time frame of conducting such inspection;

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