Circular 02/2016/tt-Byt: Supplements Article 9 Circular No. 14/2012/tt-Byt On August 31, 2012 Of The Minister Of Health Stipulates The Principles, Standards Of "good Manufacturing Practice Pharmaceutical Packaging" And ...

Original Language Title: Thông tư 02/2016/TT-BYT: Bổ sung Điều 9 Thông tư số 14/2012/TT-BYT ngày 31 tháng 8 năm 2012 của Bộ trưởng Bộ Y tế quy định các nguyên tắc, tiêu chuẩn “Thực hành tốt sản xuất bao bì dược phẩm” và ...

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Number: 02 /2016/TT-BYT
Hanoi, January 12, 2016


Plugin Fuck! Nine. I Number of hips 14 /2012/TT-BYT August 31, 2012 B Chief. B There. Y Yes.

regulation of principles, standards " I "A good practice of producing pharmaceuticals."

and the deployment guide, apply


The Code of Pharmacy. 34 /2005/QH11 June 14, 2005;

Base of Decree Stain. 63 /2012/NĐ-CP 31st Ah! 8 of 2012 of Government Functional Regulation, Mission, Regulation Okay. The limit and structure of the Ministry of Health;

On the recommendation of the Director of the Bureau of Pharmacology, the Legal Affairs Minister-the Ministry of Health,

Minister of Health, Department of Health. b Article 9 Digital News 14 /2012/TT-BYT August 31, 2012 by the Minister of Health regulating the principles, the standard "Good Practice Production of Pharmaceutical packaging" (GMP) and the guidance of the law. to Use it, apply as follows:

What? 1. Add d Point and Point to paragraph 5 Article 9 Digital News 14 /2012/TT-BYT August 31, 2012 by the Minister of Health regulating the principles, the standard "Good Practice Production of Pharmaceutical packaging" (GMP) and the deployment guide, apply:

What? 9. The deployment plan

5. Roadmap execution:

d) Since this Private Day is in effect, the basis of the production of drugs on the market must use the packaging directly with the drug (the first-grade packaging packaging) provided by the basis of packaging that reaches the principle, the drug-packaging GMP standard or has a product. in the following certificates:

-The certification base for the production of the pharmaceutical packaging to the standard GMP standard by the health regulator or drug administration has acute jurisdiction.

-The certificate is eligible for the production of pharmaceutical packaging provided by the health management agency or drug management at the level; Text administered by the drug governing body of the member countries to the international agreement on the pharmaceutical sector harmony (The Times). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use, ICH), European Union (Europe Union, EU), Pharmaceutical Inspection System (Pharmaceutical Inspection Co-operation Scheme, PIC/S) confirm the production of packaging used in the pharmaceutical, food; Drug Master File (DMF) Document is accepted by the Management Agency. The U.S. Food and Drug Administration (USFDA) is accompanied by information on the USFDA's electronic information site.

-Certificate of ISO 15378 (Primary packaging materials for medical products-Particular requirements for application of ISO 9001:2008 with reference to Good Manufacturing Practices (GMP)) due to the certification organization has been recognized by the public body. received international review and recognition by international standards.

-ISO 13485 (Medical Devices-Quality management systems-Requirements for regulation purposes) for packaging is a medical instrument used for drug packaging (catrige, injection injection) due to the organization certification has been recognized by the agency. International review and recognition of international standards.

-The certification certification is ISO 9001 (Quality management systems-Requirements) for the raw packaging of packaging materials that are created in the process of drug production.

Bureau Veritas, TÜV (Technischer Überwachongs 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 ÜberwJoint), International Certification Management GmbH.

What? 2. Terms of execution

1. This message has been in effect since 1 March 2016.

2. The Department of Pharmacology in coordination with the Department of Technology and Training Sciences, proposes the Minister of Health to issue a Notice of Amendment, addition or abolish the international recognition agency stipulated at Section 5 Article 9 which is added at Article 1 of Information. Come on.

3. The pharmaceutical packaging GMP certificates issued before the date of this date are valid for the expiration of the validity period of the certificate.

In the course of execution, if there is difficulty in the process, the agency suggests that the organization reflects promptly on the Department of Pharmacology-the Ministry of Health to review the ./.



Mr. Lê Tuan