Useful Links

Below are some links which are invaluable information sources and excellent reference material. 

The MHRA (Medicines and Healthcare products Regulatory Industry) is the Governmental agency with responsibility for standards of safety, quality and performance. As such, it is definitely worth keeping abreast of the content of this site. Below are the key pages of interest: 

• MHRA Home Page  

• Legislation, Guidance and Policy 

• Pharmaceuticals Industry Home Page 

• Manufacturing and Wholesale 

• How to sign up to alerts 

• Safety warnings, alerts and recalls page 

• Defective Medicines Report Centre 

Other useful information sources include: 

• UK Veterinary Medicines Directorate (VMD) 

• UK Department of Health 

• European Pharmaceuticals Regulatory Body  - European Medicines Agency (EMA) 

• Food and Drug Administration (FDA) 

• UK Pharmaceuticals Legislation - 1968 Medicines Act  

• Marketing Authorisations (MAA) 

• Manufacturing Authorisation (MIA) and Wholesale Dealers (WL) 

• Clinical Trial Material Manufacturers Authorisation (MIA(IMP)) 

• Specials Manufacturing Guidance 

• UK Pharmaceutical Product Information Leaflets and SmPCs - Electronic Medicines Compendium 

Below are links to key pages relating to European Pharmaceuticals Legislation - Eudralex: 

• Eudralex Home Page 

• Volume 1 - Legislation for medicines for human use 

• Volume 5 - Legislation for medicines for veterinary use 

• Volume 5 - Notice to applicants / regulatory guidelines 

• Volume 4 - GMP 

• Volume 9 - Pharmacovigilance 

• Volume 10 - Clinical Trials 

Here is some useful material for Qualified Person Professional Bodies information: 

• Royal Society of Chemistry 

• Royal Pharmaceutical Society 

• Society of Biology