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Comment on drafts (Pharmeuropa)

All new and revised monographs and general texts that are intended for inclusion in the European Pharmacopoeia are published in Pharmeuropa for public consultation. Your comments on these general texts and draft monographs are welcomed.

Although draft monographs are only published for public consultation at this stage and must therefore not to be regarded as official standards, they will, once adopted by the European Pharmacopoeia Commission at a later date, become applicable and legally binding standards for the substances concerned. It is therefore extremely important that manufacturers and users of the substances provide feedback on the draft monographs. Comments made after adoption of the monograph and/or the publication in the Ph. Eur. would be too late to be considered and manufacturers and users of the substances may then be in a position where their substance is not compliant to the Ph. Eur. monograph which is a legal standard in Europe.

It is in everyone’s interest to have monographs in the European Pharmacopoeia which reflect the quality of the substances available in Europe. EDQM would therefore like to take the opportunity to strongly encourage all interested manufacturers and users to review the draft monographs and to check the compliance of their substances with the new or revised drafts monographs.

 

Pharmeuropa is a free online EDQM publication providing:

  • public inquiries on draft European texts or on matters of general policy,
  • the latest official announcements on freshly adopted monographs,
  • the latest news on Pharmacopoeial harmonisation,
  • a readers’ tribune, and
  • access to three databases.

 

How do I comment?

Before you comment, please read the following document: How to comment

Please see Pharmeuropa Bio and Scientific Notes

 

Pharmeuropa Bio & Scientific Notes

  • Contains all the news in the biological standardisation area and scientific articles linked to the work of the European Pharmacopoeia.
  • Instructions for authors.
  • Articles should be sent (for the attention of the Editors of Pharmeuropa or Pharmeuropa Bio & Scientific Notes) by email or by post.

Pharmeuropa archives containing past issues of Pharmeuropa.

- See more at Pharmeuropa Bio and Scientific Notes

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