of 6 November 2001 on the Community code relating to medicinal products for human use
For the purposes of this Directive, the following terms shall bear the following meanings:
1. Proprietary medicinal product:
Any ready-prepared medicinal product placed on the market under a special name and in a special pack.
2.
Medicinal product:
Any substance or combination of substances presented for treating or preventing disease in human beings. It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance. The increasing use of electronic networks for communication of information on adverse reactions to medicinal products marketed in the Community is intended to allow competent authorities to share the information at the same time. Read more ...


 

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