Stage 6 Regional Adoption and Implementation

The last two stages of the implementation of the harmonized chapters and monographs take place independently according to the procedures established by each pharmacopeial organization. 

The document is submitted for adoption to the organization responsible for each pharmacopeia. Each pharmacopeia incorporates the harmonized draft according to its own procedures. Stylistic and editorial differences may occur. 

Adopted texts are published by the three pharmacopeias in their supplements, or where applicable, in a new edition. 

If necessary, the Stage 5B draft may be adopted with some amendments (local requirements) corresponding to a general policy in the national or regional (European) area. If a pharmacopeia includes a local attribute after the sign-off of a text, it will inform the PDG. It is, however, preferred to include the nonharmonized text in Stage 5B as an alert to the other pharmacopeias that there will be some differences in text in the final document. 

Users of the pharmacopeias are appropriately informed of the harmonization status of monographs and general chapters. In the European Pharmacopoeia (EP) and USP-NF, for general chapters, this is done via a preliminary paragraph. For the JP, a notification is made by the MHLW and information is given in a general chapter. 

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