2. Legislative documents governing medicines regulation

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1. Legislative documents governing medicines regulation

(This section is organised in the form of a book, please follow the blue arrows to navigate through the book or by following the navigation panel on the right side of the page.)

In the European Union (EU), nobody can market a medicine without holding a marketing authorisation (MA) from the regulatory authorities. A MA should only be granted to medicines fulfilling the above basic requirements – i.e., they are effective and sufficiently safe.

The rules needed for obtaining and maintaining a MA are laid out in a series of legislative documents of different status:

  • Regulations and directives.
  • Guidelines
  • Other types of documents.