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)
Title:
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.