Links & News
Legal requirements / Guidelines
- German Drug Law ("16 AMG Novelle") full text; Final: Oct. 2012
- German Laws in English
- German Reform of the Market for Medicinal Products
- GVP Modules
- GDP Guideline (Guideline on Good Distribution Practice) 2013/C 68/01 07.03.2013
- IPEC Europe GDP Audit Guide for Pharmaceutical Excipients
- Delegated Act on Rules for unique Identifier
- COMMISSION IMPLEMENTING REGULATION (EU) No 520/2012
- EU Legislation - Eudralex
- Eudravigilance
- FDA Guidance Documents
- Part 11, Electronic Records
- ISPE Guidance documents by topic (GAMP®, Biotech etc.)
Authorities
- BfArM Federal Institute for Drugs and Medical Devices
- BMG The Federal Ministry of Health
- MHRA Medicines and Healthcare products Regulatory Agency
- EMA The European Agency for the Evaluation of Medicinal Products
- HMA Heads of European Medicines Agencies
- FDA US Food and Drug Administration
- PEI Paul-Ehrlich-Institut
- BVMed - German Medical Technology Association
Information / Databases
- Eudra GMDP database
- E-learning EVMPD (Download)
- Process validation guideline
- Trade Promotion
- Electronic Register of Studies
- Clinicaltrials
- European ADR Database
- PROTECT Drug Consumption database
- PROTECT ADR Database
- PharmNET Portal for Drug Information
- MSSO MedDRA Maintenance Support
- Medline US National Library of Medicine
- National Libarary of Medicine
- Nature
- The Cochrane Library
News
- EDQM database "Know-X" with information on falsified medicines
- PV Audit Group (Expert forum and network)
- Q&A GCP Volume 10
- Q&A GMP Audits
- Regulation on clinical trials repealing Directive 2001/20/EC
- Reporting Requirements for ICSRs in the interim period
- Q&A on transitional measures for implementation of the PV legislation
- Non Compliance GDP: EUDRA GMDP