Information for the attention of marketing authorization (MA) holders of medicinal products for human use

A document setting out the requirements for Type II variations of the marketing authorisation file, involving a revision of sections 4.6 (fertility, pregnancy and lactation), 5.3 (preclinical safety data) and 6.6 (special precautions for disposal of a used medicinal product or waste materials derived from such a medicinal product and other handling of the product) of the summary of product characteristics (SPC) is published on the page about variations in the column "Marketing authorization procedure" for medicines for human use.

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Document: Guidance for Type II variations involving revision of the SPC sections 4.6, 5.3 and 6.6

Contact : Sonja Beken,












Last updated on 06/01/2012