G/TBT/N/KAZ/36

29 April 2026

(26-3202)

Committee on Technical Barriers to Trade

Original: English

1.

Notifying Member: KAZAKHSTAN

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

The Eurasian Economic Commission

Department for Technical Regulation and Accreditation

2 Letnikovskaya St., bld.1/2

115114 Moscow, Russian Federation

Tel: +7(495)669-24-00

Fax: +7(495)669-24-15

E-mail: dept_techregulation@eurasiancommission.org

Website: www.eurasiancommission.org

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Pharmaceuticals

5.

Details of notified document(s) (title, number of pages and languages, means of access): Draft amendments to the Rules of Good Manufacturing Practice in the Eurasian Economic Union; (158 page(s), in Russian)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

6.

Description of content: Draft Amendments provides for the supplementation of the Rules of Good Manufacturing Practice with Requirements for the production of high-tech medicines harmonized with the current version of the Rules of Good Manufacturing Practice of the European Union and relevant international standards to ensure stable quality of the production process of the specified group of drugs in order to promptly identify deviations in the production process, as a result of which the finished product will be recognized as substandard

7.

Objective and rationale, including the nature of urgent problems where applicable: Protecting the life and health of a patient (as the end user of medicines);

- protecting the interests of the healthcare system;

- protection of the interests of manufacturers of high-tech human medicines and manufacturers of similar groups of veterinary medicines;

- protection of the interests of pharmaceutical inspectorates of the Eurasian Economic Union Member States conducting pharmaceutical inspections;

- protection of the interests of authorized bodies (expert organizations) that perform the procedure for assessment of the module 3 registration dossier of a medicines from the position of proving its safety and compliance with a given quality standard, the best effectiveness and a favorable benefit-risk profile

8.

Relevant documents:

The draft document has been posted on the legal portal of the Eurasian Economic Union at:

https://regulation.eaeunion.org/orv/3269/

9.

Proposed date of adoption: To be determined

Proposed date of entry into force: To be determined

10.

Provision of comments

Final date for comments: 28 June 2026

[X] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

Ministry of Trade and Integration of the Republic of Kazakhstan

Department for Foreign Trade Activity

8 Mangilik Yel ave., "House of Ministries" Adm. Bldg., Entrance 7

Asana, Republic of Kazakhstan, 010000

Tel: +7 7172 74 37 61

+7 7172 76 86 02

Fax: +7 7172 76 88 04

E-mail: wto.kaz.ntf@gmail.com

Eurasian Economic Commission

Department for Technical Regulation and Accreditation

2 Letnikovskaya St., bld.1/2

115114 Moscow, Russian Federation

Tel: +7(495)669-24-00

Fax: +7(495)669-24-15

E-mail: dept_techregulation@eurasiancommission.org

Website: www.eurasiancommission.org