Medicines and active ingredient manufacturing ordinance
| Basic data | |
|---|---|
| Title: | Ordinance on the application of good manufacturing practice in the manufacture of medicinal products and active ingredients and on the application of good professional practice in the manufacture of products of human origin |
| Short title: | Medicines and active ingredient manufacturing ordinance |
| Abbreviation: | AMWHV |
| Type: | Federal Ordinance |
| Scope: | Federal Republic of Germany |
| Issued on the basis of: | Sections 12, 54, 56, 56a and 83 AMG |
| Legal matter: | Special administrative law , pharmaceutical law |
| References : | 2121-51-46 |
| Issued on: | November 3, 2006 ( BGBl. I p. 2523 ) |
| Entry into force on: | November 10, 2006 |
| Last change by: |
Art. 3a G of 9 August 2019 ( Federal Law Gazette I p. 1202, 1206 ) |
| Effective date of the last change: |
August 16, 2019 (Art. 21 G of August 9, 2019) |
| GESTA : | M014 |
| Weblink: | Text of the regulation |
| Please note the note on the applicable legal version. | |
The Ordinance on the Manufacture of Drugs and Active Ingredients - AMWHV is an implementation ordinance of the German Medicines Act (AMG) .
Goal setting
The AMWHV regulates the application of “ good manufacturing practice ” (GMP) or “good professional practice” in the manufacture of pharmaceuticals and medicinal substances and sets the content of parts I and II of the GMP guidelines for human and veterinary medicinal products of the European Union established principles and guidelines. The AMWHV came into force in November 2006 and replaced the operating regulations for pharmaceutical companies (PharmBetrV) that had previously been in force . A major difference to PharmBetrV is that the AMWHV also covers all manufacturers and distributors of medicinal substances , i.e. active substances that are intended for the manufacture of medicinal products.
Legal basis
The ordinance is derived from the authorization to issue ordinances in Section 54 (1) of the Medicines Act. Section 54 (2) names the points to be regulated in particular.
Content
The AMWHV is divided into seven sections.
- Section 1 regulates the scope of the regulation.
- Section 2 contains general requirements for the company or facility, including those for personnel, operating rooms, equipment, hygiene measures , storage, documentation and the quality management system .
- For medicinal products, blood products and other blood components as well as products of human origin, Section 3 contains regulations, for active substances of non-human origin, Section 4, which regulates the manufacture, testing, labeling, approval, placing on the market , import , retained samples , complaints and recalls and storage the documentation.
- Section 5 contains supplementary regulations for medicated feed and blood donation facilities , as well as special provisions for extraction and tissue facilities as well as for tissue donation laboratories .
- Section 6 defines administrative offenses ; Section 7 contains transitional and final provisions.
Web links
- Text of the Ordinance on the Manufacture of Drugs and Drugs - AMWHV
- EudraLex, Volume 4 - Good manufacturing practice (GMP) Guidelines
Individual evidence
- ↑ Operating Regulations for Pharmaceutical Entrepreneurs valid until November 10, 2006
