EU GMP: European guidelines for the manufacture of medicinal products
Following a change in the law, doctors have also been able to prescribe medical cannabis in Germany since March 2017. Alongside the general regulations according to pharmaceutical law, the prescribed products also have to comply, however, with the regulations in the German Narcotics Act and the EU GMP and EU GDP guidelines (European quality guidelines for good manufacturing and distribution practice).
In cooperation with the BfArM (Federal Institute for Drugs and Medical Devices), WEECO Pharmaceuticals thus checks all manufacturers and suppliers for their conformity with the legal regulations and the required quality standards. All WEECO partners must comply with the highest pharmaceutical quality standards in the world – the GMP guidelines.
EU GDP: European guidelines for the distribution of medicinal products
GDP (Good Distribution Practices) are EU guidelines that define quality standards for the purchasing, storage, transport and distribution of medicines.
WEECO GmbH is one of the leading pharmaceutical wholesalers certified in accordance with the EU GDP. Using a modern quality management system, all processes in the supply chain from the manufacturing process through to delivery to pharmacies are strictly monitored and documented.
Regulations and guidelines
WEECO GmbH is a licensed pharmaceutical wholesaler in accordance with Section 52a AMG (German Medicines Act) and also has a “licence for the trade in narcotic drugs” in accordance with Section 3 BtMG (German Narcotic Drugs Act).
- EG-Guideline- directive 2001/83/EC
- EG-Guideline- directive 2003/94/EC
- Medicines Trade Ordinance AM-HandelsV
- QMS according to §1a “Quality Assurance System” (AM-HandelsV)
- EU GDP Guideline (Good Distribution Practice) for medicinal products for human use and for active substances
- EU-GMP-Guideline(Good Manufacturing Practice)
- EU-GACP-Guideline (Good Agriculturing and Collecting Practices by WHO) for the review of the grower / cultivator
- EudraGMDP database for checking our suppliers manufacturers certificates
- Medicines Act (AMG) and others §52 wholesale license, §72 import license, §13 manufacturer license, §§14,15,19 competent person and their specialist knowledge in handling pharmaceuticals, … and much more.
- Narcotics Act (BtMG) and others §3 Permission to deal with narcotics
- Drug and Active Substance Manufacturing Ordinance (AMWHV), etc. §16 Approval by a competent person
- Narcotics Foreign Trade Ordinance (BtMAHV) and others §1 + 6 import application
- Inspectors Working Group (GMP/GDP) European Medicine Agency (EMA)
- United Nations Convention of 1961/1971/1988
- German (DAB) and European Pharmacopoeia (Ph.Eur.)
- General Data Protection Regulation (GDPR) – Regulation (EU) 2016/697
GACP – Richtlinie: Good Agricultural And Collection Practice
GACP (Good Agricultural and Collection Practice) are guidelines that are designed to guarantee a high level of quality in the cultivation of plant-based raw materials through to the manufacturing of herbal medicines and substances.
In particular, the guidelines cover the breeding, cultivating, harvesting and initial processing stages.
