Good Practice guidelines

Good Manufacturing Practice (GMP) guidelines


Part I – Basic Requirements for Medicinal Products


Part II – Basic Requirements for Active Substances used as Starting Materials


Part III – GMP related documents



Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4 and operational as of 22 May 2018.


Standardised GMP forms

Good Distribution Practice guidelines
Good Clinical Practice guidelines
Good Pharmacovigilance Practice Guidelines

In accordance with the Law on medicines, Good Pharmacovigilance Practice Guidelines are applied in the field of pharmacovigilance, which are available on the website of the European Medicines Agency (EMA)


Search register

Here you can search for medicines in our register

Sign up for