GMP: New Document about Duplicate Marketing Authorisation Applications
20.10.2011
According to Article 82 of the EU Regulation No 726/2004 \"only one authorisation may be granted to an applicant for a specific medicinal product\". In exceptional cases though, the same applicant may submit more than just one application.
The source of the news: http://ec.europa.eu/health/files/latest_news/2011_09_upd.pdf
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