1. Legislative documents governing medicines regulation

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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.