Useful Websites


Regulatory Affairs

  • European Medicines Agency (EMA)
  • Food and Drug Administration (FDA)
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
  • Medicines Healthcare products Regulatory Agency (MHRA)
  • World Health Organization (WHO)


  • British Pharmacopoeia (BP)
  • European Pharmacopoeia (EP)
  • Japanese Pharmacopoeia (JP)
  • United States Pharmacopeia (USP)  

Case study - Small Scale GMP Manufacturing


Certificates and Licences

Eurofins Bactimm                                 

 GMP (English)


 ISO 9001:2008

 ISO 13485:2003 

 Manufacturing License 2015 (Dutch)

 KNMP 2017 (Dutch)

 KNMP 2017 (English)

 Eurofins MicroSafe Laboratories






 Manufacturing License 2017 (Dutch)


 Eurofins Spinnovation Analytical 

 Manufacturing License 2017 (Dutch) 


 Eurofins Prolepha Labs


 Manufacturing License 2015 (Dutch)

 Eurofins PROXY Laboratories



 Manufacturing GMP License 2017 (Dutch)


 UA License

 Veterinary Medicine Certificate

 Veterinary Medicine License

 WHO-Annexes to Letter