The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

Eudralex Volume 2C Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC (Official Journal C 133, 8/6/2006 p. 5 - 7): Annex


European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium),

Document Type:
Examples of issues which normally would not be considered as grounds for a ‘Potential Serious Risk to Public Health in accordance with specific requirements according to Directive 2001/83/EC as amended.

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information