Circular No. 02/2016/TT-BYT supplements the standards for Good Manufacturing Practices for Pharmaceutical Packaging (GMP) and specifies the mandatory implementation timeline from the date of effectiveness. Pharmaceutical production facilities must use primary packaging provided by GMP-compliant establishments or those with appropriate certification.
适用范围
Pharmaceutical production and business establishments, pharmaceutical packaging production facilities
要点
- Pharmaceutical production facilities must use primary packaging from the date this Circular becomes effective.
- Primary packaging must be provided by GMP-compliant establishments or have appropriate certification such as GMP Certificate, ISO 15378, ISO 13485, ISO 9001.
- The Drug Administration will review and propose amendments to the Circular regarding international recognition agencies.
- GMP Certificates issued before the date this Circular becomes effective remain valid until their expiration date.
- This Circular takes effect from March 1, 2016.
🌐 本文件的社会影响
- Positive impact: Ensuring the quality of pharmaceutical packaging, enhancing drug safety for the public.
- Negative impact: Increased production costs due to GMP requirements and certifications.
❓ 常见问题
What must pharmaceutical production facilities do from the date this Circular becomes effective?
Pharmaceutical production facilities must use primary packaging provided by GMP-compliant establishments or those with appropriate certification such as GMP Certificate, ISO 15378, ISO 13485, ISO 9001.
How many types of certificates are approved?
Five types of certificates are approved: GMP Certificate, ISO 15378 Certificate, ISO 13485 Certificate, ISO 9001 Certificate.
What is the validity period of GMP Certificates issued before the date this Circular becomes effective?
GMP Certificates issued before the date this Circular becomes effective remain valid until their expiration date.
Which agency is responsible for reviewing and proposing amendments to the Circular?
The Drug Administration will coordinate with the Science, Technology, and Training Department to review and propose amendments to the Circular regarding international recognition agencies.
When does this Circular take effect?
This Circular takes effect from March 1, 2016.
全文
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MINISTRY OF HEALTH |
SOCIALIST REPUBLIC OF VIET NAM |
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Number: 02/2016/TT-BYT |
Hanoi, January 12, 2016 |
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./.
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Place of Receipt: |
DEPUTY MINISTER |
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