Circular No. 02/2016/TT-BYT supplements Article 9 of Circular No. 14/2012/TT-BYT dated August 31, 2012, issued by the Minister of Health, stipulating the principles and standards for "Good Manufacturing Practices for Pharmaceutical Packaging" and providing guidance on implementation and application.

CIRCULAR

Supplementing Article 9 of Circular No. 14/2012/TT-BYT dated August 31, 2012, issued by the Minister of Health, stipulating good manufacturing practice (GMP) principles and standards for pharmaceutical packaging production and guidance on implementation and application

Pursuant to the Medicine Law No. 34/2005/QH11 dated June 14, 2005;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Department of Medicine Administration and the Director of the Legal Department of the Ministry of Health,

The Minister of Health issues this Circular supplementing Article 9 of Circular No. 14/2012/TT-BYT dated August 31, 2012, issued by the Minister of Health, stipulating GMP principles and standards for pharmaceutical packaging production and guidance on implementation and application as follows:

Article 1. Supplementing Point d and Point đ of Clause 5 of Article 9 of Circular No. 14/2012/TT-BYT dated August 31, 2012, issued by the Minister of Health, stipulating GMP principles and standards for pharmaceutical packaging production and guidance on implementation and application:

Article 9. Implementation Plan

5. Implementation timeline:

d) From the date this Circular takes effect, pharmaceutical production facilities circulating on the market must use primary pharmaceutical packaging (first-level packaging) provided by packaging production facilities that meet GMP packaging standards or possess one of the following certificates:

- Certificate of compliance with GMP standards for pharmaceutical packaging production issued by competent health or drug administration authorities.

- Certificate of eligibility for pharmaceutical packaging production issued by competent health or drug administration authorities of the country of origin; Documents confirmed by drug administration agencies of member countries participating in international agreements on harmonization of pharmaceutical fields (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH), European Union (EU), Pharmaceutical Inspection Co-operation Scheme (PIC/S) regarding the production of packaging used in pharmaceuticals and food; Drug Master File (DMF) accepted by the United States Food and Drug Administration (USFDA) accompanied by a link to information published on the USFDA's website.

- Certificate of compliance with ISO 15378 standard (Primary packaging materials for medicinal products - Particular requirements for application of ISO 9001:2008 with reference to Good Manufacturing Practices (GMP)) issued by certification organizations recognized internationally according to international standards.

- Certificate of compliance with ISO 13485 standard (Medical Devices - Quality management systems - Requirements for regulatory purposes) for packaging that is medical devices used to pre-package drugs (cartridge, syringe) issued by certification organizations recognized internationally according to international standards.

- Certificate of compliance with ISO 9001 standard (Quality management systems - Requirements) for raw materials used in the manufacture of pharmaceutical packaging where the pharmaceutical packaging is formed during the drug production process.

đ) The international recognition organizations referred to in Point d of this Clause include: Bureau Veritas, TÜV (Technischer Überwachungs Verein), SQS (Swiss Association for Quality and Management Systems), SGS (Société Générale de Surveillance), IQnet (The International Certification Network), BSI (The British Standards Institution), DQS (German Registration for Management Systems), GTÜ (Gesellschaft für Technische Überwachung), International Certification Management GmbH.

Article 2. Implementation clause

1. This Circular shall take effect from March 1, 2016.

2. The Department of Medicine Administration shall coordinate with the Department of Science, Technology and Training to review and propose to the Minister of Health to issue a Circular amending, supplementing, or abolishing the international recognition organizations specified in Point đ of Clause 5 of Article 9 supplemented in Article 1 of this Circular.

3. Certificates of GMP compliance for pharmaceutical packaging issued before the effective date of this Circular remain valid until the expiration date of the certificate.

In the course of implementation, if there are difficulties or obstacles, please promptly report to the Department of Medicine Administration - Ministry of Health for consideration and resolution./.