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PSMF establishment and maintenance, business as usual?
Since the implementation of Directive 2010/84 and Regulation 1235/2010, marketing authorisation holders (MAHs) with products on the European market are obliged to maintain, and make available upon request, a Pharmacovigilance System Master File (PSMF).
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- Media Use
The content may be downloaded by journalists, bloggers, columnists, creators of public opinion, etc. It can be used and shared in different media channels to convey, narrate, and comment on your press releases, posts, or information, provided that the content is unmodified. The author or creator shall be attributed to the extent and in the manner required by good practice (this means, for example, that photographers should be attributed).
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