Human Medicines - EMEA Pre-Submission Procedural Advice Questions & Answers
The information provided in this guidance document is currently under review, following the entry into force of the new pharmaceutical legislation on 20th November 2005. Questions and Answers will be updated progressively, and will be marked by "New" or "Rev." upon publication.
http://www.emea.europa.eu/htms/human/presub/list.htm
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