DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 №73

About the Procedure for certification of authorized persons of producers of medicines

Astana

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 9 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 99 of appendix №1 to the Regulations of work of the Euroasian 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 certification of authorized persons of producers of medicines.

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, except for Item 6 of the Procedure approved by this Decision.

Item 6 of the Procedure approved by this Decision becomes effective since January 1, 2019.

Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 №73

Procedure for certification of authorized persons of producers of medicines

1. This Procedure determines requirements imposed to education, training and length of service of authorized persons of producers of medicines of state members of the Eurasian Economic Union (further respectively – authorized persons, state members, the Union) and to carrying out their certification.

2. The certified authorized person shall have at least 3 years of working life in the field of production, either quality assurance, or quality control of medicines and the finished higher education in one of the following areas:

a) chemical;

b) chemical and technological;

c) chemical and pharmaceutical;

d) biological;

e) biotechnological;

e) microbiological;

g) pharmaceutical;

h) medical;

i) veterinary.

3. Also persons having the finished higher education in the field of physics and technology sciences are allowed to certification on the right of implementation of functions of the authorized person at the companies performing production of medical gases.

4. Also persons having the finished higher education in the field of nuclear physics and radiophysics are allowed to certification on the right of implementation of functions of the authorized person at the companies performing production of radio pharmaceutical drugs.

5. Compliance of the national directions of preparation specified in Items 2 – 4 presents of the Procedure to the fields of education is established by the authorized body of state member in the field of drug circulation performing certification of authorized persons (further – authorized body).

6. The certified authorized person, except for persons specified in Items 3 and 4 of this Procedure in case of receipt of the higher or additional education shall be trained on the following rates (disciplines, modules):

a) applied (medical and biological) physics;

b) general and inorganic chemistry;

c) organic chemistry;

d) analytical chemistry;

e) pharmaceutical chemistry (including the analysis of medicines);

e) biological chemistry;

g) physiology;

h) microbiology;

i) pharmacology;

j) pharmaceutical technology;

k) toxicology (toxicological chemistry);

l) pharmacognosy.

7. The procedure of certification includes check of compliance of education, training and length of service of the certified authorized person in the requirements established by this Procedure and rules of proper production practice of the Union. By results of the specified check by authorized body the decision on certification of the authorized person is made (with indication of types of activity on production of medicines according to rules of proper production practice of the Union on which implementation the authorized person is certified).

The list and format of the documents submitted by the certified authorized person, stages of the procedure and procedure for decision making are determined by authorized body.

8. The decision of authorized body on certification of the authorized person confirms that the authorized person meets the requirements established by this Procedure.

9. Data on the certified authorized persons are entered in the register of authorized persons of the Union and posted on the official site of authorized body and on the official site of the Union on the Internet with observance of restrictions about personal data protection.

10. The decision on certification of the authorized person is subject to cancellation by authorized body in case:

a) representation factual determinations by the certified authorized person of false information and documents;

b) giving by the authorized person in authorized body of the statement for cancellation of the decision on its certification;

c) in other cases, stipulated by the legislation state members.

11. Data on cancellation of the decision on certification of the authorized person are entered in the register of authorized persons of the Union and posted on the official site of authorized body and on the official site of the Union on the Internet with observance of restrictions about personal data protection.

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