Thông tư 02/2016/TT-BYT

CIRCULAR

ADDITION TO ARTICLE 9 OF THE CIRCULAR NO. 14/2012/TT-BYT DATED AUGUST 31, 2012 BY MINISTER OF HEALTH ON PRINCIPLES AND CRITERIA FOR “GOOD MANUFACTURING PRACTICE FOR PHARMACEUTICAL PACKAGING" AND GUIDELINES FOR IMPLEMENTATION

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

Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 on functions, missions, authority and organizational structure of the Ministry of Health;

At the requests of the Head of the Drug Administration of Vietnam and Head of the Department of Legal affairs - Ministry of Health.

Minister of Health issues the Circular on the following addition to Article 9 of the Circular No. 14/2012/TT-BYT dated August 31, 2012 by Minister of Health on principles and criteria for “Good manufacturing practice (GMP) for pharmaceutical packaging” and guidelines for implementation:

Article 1. Point d and Point dd are added to Section 5, Article 9 of the Circular No. 14/2012/TT-BYT dated August 31, 2012 by Minister of Health on principles and criteria for “Good manufacturing practice (GMP) for pharmaceutical packaging” and guidelines for implementation.

Article 9. Plan of implementation

5. Progress of implementation:

d) From the date that this Circular comes into force, manufacturers of drugs being sold in the market must use primary packaging, which are provided by packaging producers fulfilling GMP requirements for pharmaceutical packaging or possessing one of these certificates:

- Certificates of conformity of pharmaceutical packaging producer to GMP, as issued by competent health or pharmaceutical authorities.

- Certificates of eligibility for production of pharmaceutical packaging, as issued by competent health and pharmaceutical authorities in relevant countries, papers granted by pharmaceutical authorities in nations that participate in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH), European Union (EU), Pharmaceutical Inspection Co-operation Scheme (PIC/S) for endorsement of manufacturing of packaging for pharmaceutical products and foodstuffs, Drug Master File (DMF) recognized by U.S. Food and Drug Administration (USFDA) with the link to the information post on the website of USFDA.

- ISO 15378 certificate (Primary packaging materials for medicinal products - Particular requirements for application of ISO 9001:2008 with reference to Good Manufacturing Practices (GMP)) as issued by a certifying body that has been assessed and recognized by an international accreditation organization according to international standards.

- ISO 13485 certificate (Medical Devices - Quality management systems - Requirements for regulatory purposes) for packaging of drug containment tools (cartridge and syringe) as issued by a certifying body that has been assessed and recognized by an international accreditation organization according to international standards.

- ISO 9001 certificate (Quality management systems - Requirements) for materials of pharmaceutical packaging shaped right in the process of drug manufacturing.

dd) International accreditation organizations as stated in Point d of this Section 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

1. This Circular comes into force as of March 01, 2016.

2. Drug Administration of Vietnam shall cooperate with the Administration of Science Technology and Training to review and present information to the Minister of Health for issuance of circulars on amendments to or removal of international accreditation organizations as stated in Point dd, Section 5, Article 9 as supplemented by Article 1 of this Circular.

3. Certificates of GMP for pharmaceutical packaging, which were issued before the date that this Circular takes effect, shall remain effective to their date of expiry.

Difficulties shall be reported to the Drug Administration of Vietnam - Ministry of Health for solutions./.