DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 №83

About approval of rules of conducting pharmaceutical inspections

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, 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, and the Decision of the Supreme Eurasian economic council of December 23, 2014 "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 solved No. 108:

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.

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.

 

Members of council of the Eurasian economic commission: From the Republic of Armenia

V. Gabriyelyan

From the Republic of Belarus

V. Matyushevsky

From the Republic of Kazakhstan

A. Mamin

From the Kyrgyz Republic

O. Pankratov

From the Russian Federation

I. Shuvalov

 

Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 № 83

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

I. General provisions

1. These rules establish single procedure for carrying out by pharmaceutical inspectorate of pharmaceutical inspections of production of medicines on compliance to requirements 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 (further - inspection, Rules of proper production practice).

2. When conducting inspection the inspection team which part are the leading pharmaceutical inspector (further - the leading inspector) and pharmaceutical inspectors is created. When conducting inspection there can be involved experts.

Requirements to the number of inspection team, skill level of employees of pharmaceutical inspectorate and the experts involved inspection team shall conform to the requirements established by the quality manual for inspection of the corresponding type of pharmaceutical production and also the General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 82.

3. The pharmaceutical inspectorate provides confidentiality of information containing in documents of inspection.

4. Financing of expenses on conducting inspections is performed at the expense of means of the inspected subject or his authorized representative.

II. Determinations

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

"the applicant on conducting pharmaceutical inspection" - the inspected subject, the holder of the registration certificate, the applicant on registration or their authorized representative;

"inspection" - stage of pharmaceutical inspection during which the inspection team holds events according to the program of inspection;

"the inspected subject" - the organization which is performing activities for production of medicines and having the permission (license) for such type of activity issued by authorized body of the manufacturing country;

The concepts "pharmaceutical inspection", "pharmaceutical inspectorate" and "pharmaceutical inspector" are applied in the values determined by the General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 82.

III. Operations procedure

6. Inspections are carried out by pharmaceutical inspectorate according to the plan (schedule) of conducting inspections according to the program of inspection of production of medicines for form according to appendix No. 1 (further - the program of inspection).

Planning of inspections can be carried out according to the principles of risk management.

The plan (schedule) of conducting inspection without fail joins the following data:

basis for conducting inspection;

inspection terms;

the name of the inspected subject;

the address of the inspected production site (further - the production site).

Inspections are carried out in planned and unplanned procedure.

The basis for conducting inspection is the decision of authorized body in the field of conducting pharmaceutical inspections of state member of the Eurasian Economic Union (further respectively - authorized body, state member, the Union) and (or) the statement of the inspected subject (for example, for the purpose of licensing, registration and implementation of other procedures connected with registration or conducting the investigations connected with quality of medicines).

7. Conducting inspection with use of means of remote interaction (for example, with use of means of audio-or video conference) is allowed in particular cases according to appendix No. 2.

8. For the organization of inspection by the applicant on conducting pharmaceutical inspection (further - the applicant) representation in pharmaceutical inspectorate in Russian and (or) (in the presence of relevant requirements in the legislation of state member) in state language of state member (or in transfer into these languages) the following documents shall be provided:

for the manufacturing organization (resident) who is in the territory of state member:

statement for conducting inspection;

the copy of the file (master file) of the production site according to part III of Rules of proper production practice containing the copy of license for activities on production of medicines (in the presence);

the list of the medicines made (planned to production) on the production site according to appendix No. 3;

for the manufacturing organization (nonresident):

statement for conducting inspection;

the copy of the file (master file) of the production site according to part III of rules of proper production practice;

the copy certified in accordance with the established procedure, or the electronic copy of the operating permission (license) for production of medicines issued by authorized body of the third country in the territory of which the production site or the statement from the corresponding register of the third country in the territory of which there is inspected subject is located;

the copy of the document issued by authorized body (organization) of the country in the territory of which medicines, about compliance of production (production site) to requirements of the rules of proper production practice applied in the country of origin (in the presence) or the electronic copy or the statement from the corresponding register of the country in the territory of which there is inspected object are made certified in accordance with the established procedure;

the list of the medicines made (planned to production) on the production site.

In conducting inspection it can be refused the following cases:

the data containing in the statement for conducting inspection (or) documents provided at the request of authorized body (organization) are incomplete and (or) doubtful;

the applicant does not provide conditions of conducting inspection that makes impossible holding procedure of inspection;

expenses on conducting inspection are not paid at the scheduled time (when applicable).

9. Inspection is carried out by pharmaceutical inspectorate of state member in the territory of which there is production site.

In case of inspection of the production site which is in the territory of the third countries, the applicant has the right to file in pharmaceutical inspectorate of one of state members petition for conducting inspection.

In case of documentary drawn up refusal of pharmaceutical inspectorate of state member of conducting inspection of the production site which is in the territory of the third country, the applicant has the right to address to authorized body (organization) of other state member with the statement for conducting inspection.

The inspection initiated within the registration procedures is carried out by pharmaceutical inspectorate of the state member determined according to the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78.

10. The procedure of inspection consists of the following stages:

acceptance and examination of the submitted documents;

approval of the inspected subject or his authorized representative of terms of inspection;

forming of inspection team;

creation and the direction to the inspected subject or his authorized representative of the program of inspection;

inspection of the production site, including sampling (samples) of materials or products (if necessary) and conducting their laboratory researches;

creation of the report on conducting inspection (further - the report);

assessment (if necessary) the plan of the adjusting and warning actions, the report on its accomplishment and certificates of elimination of the revealed discrepancies;

decision making about issue or about refusal in issue of the certificate of conformity of the producer to requirements of Rules of proper production practice (further - the certificate);

issue of the certificate.

Terms of carrying out separate stages of inspection are established according to the legislation of state members taking into account these rules.

11. The inspection team is created based on the corresponding order of the head of pharmaceutical inspectorate according to the procedures established by the quality system of pharmaceutical inspectorate.

The number of inspection team constitutes at least two pharmaceutical inspectors.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info