Russia | The Draft amendments to the Rules of the Good Manufacturing Practice in the Eurasian Economic Union (30 page(s), in Russian)

Title of document
The Draft amendments to the Rules of the Good Manufacturing Practice in the Eurasian Economic Union (30 page(s), in Russian)

Description
The Draft amendments to the Rules of the Good Manufacturing Practice in the Eurasian Economic Union applies to medicinal products put into circulation on the territory of the Eurasian Economic Union and envisages the need to establish a unified approach to the procedures for qualification and validation of medicinal products, in order to prove that the parameters of critical processes (equipment) meet the specified requirements, as well as in case of significant changes in premises, equipment and processes that may affect the quality of finished products, which makes it possible to ensure stable output of products with a given level of quality at pharmaceutical enterprises.

Notifying member: Russian Federation

Notification: G/TBT/N/RUS/101

Objective tag
Prevention of deceptive practices and consumer protection; Protection of human health or safety; Quality requirements

Agency responsible
Eurasian Economic Commission Department for technical regulation and accreditation Tel: +7(495)669-24-00 Fax: +7(495)669-24-15 E-mail: dept_techregulation@eecommission.org Web-site: www.eurasiancommission.org,

Timing:

• Submission: 08/07/2020
• Reception: 09/07/2020
• Distribution: 24/07/2020
• Final date for comments: 22/09/2020
• Proposed date of adoption: N/A