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.

Reflection paper on a proposed solution for dealing with minor deviations from the detail described in the Marketing Authorisation for Human and Veterinary Medicinal products (including biological products)

Origin/Publisher:

EMEA http://www.ema.europa.eu/

Document Type:
Statement
Content:
In this statement the EMEA emphasizes the responsibilities of the Qualified Person with respect to batch certification and release and the obligation of the manufacturer to keep the supervisory authority and the competent authority issuing the relevant marketing authorisation informed about non conforming batches.

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

OK