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Answer:

New and revised texts (monographs and general chapters) are submitted for adoption at one of the three sessions of the European Pharmacopoeia Commission held every year. The programme is as follows

  • Adoption (March, June and November);
  • Publication (6 months after adoption);
  • Implementation (6 months after publication).

Texts indicated as ‘corrected’ are published without prior submission to the EPC for adoption and are effective from the publication date. A correction must be taken into account not later than the end of the month following the month of publication of the corrected text.

In exceptional cases, texts may be implemented earlier than the schedule given above, in which case notification is made via, for example, the EDQM website, the Ph. Eur. itself (homepage) and potentially via Pharmeuropa.

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