The revision of Chapters 17.1 and 17.2 of Pharmacopoea Helvetica 12
29 April 2022 – The chapter 17.1 “General requirements for the manufacture of formulary medicinal products" and the associated explanatory chapter 17.2 have been extensively revised and will be integrated into the upcoming issue of the Pharmacopoea Helvetica to be published in October 2022. The revised Ordinance on Medicinal Products stipulates in Article 39 para. 2 that the Pharmacopoea Helvetica regulates all content-related and formal labelling requirements for formulary medicinal products. Currently, chapter 17.1 "General requirements for the manufacture of medicinal products" of the Pharmacopoea Helvetica only regulates which aspects are to be taken into account in the labelling of formulary medicinal products. However, the chapter lacks concrete specifications on content and form. As a result, the labelling requirements as stipulated in Chapter 17.1 must be specified and complemented. In addition to the labelling requirements, Chapter 17.1 also contains further requirements for medicinal products subject to authorization. In the revised Therapeutic Products Act (TPA) and its implementing detailed guidelines, the requirements for medicinal products subject to authorization are now comprehensively defined. As a result, there is no longer any need to regulate these contents in parallel in the Pharmacopoea Helvetica, which is why the revised Chapter 17.1 of the Pharmacopoea Helvetica mainly focuses on the manufacture of formulary medicinal products.
The definitive Chapters 17.1 and 17.2 were adopted by the Swiss Pharmacopoeia Commission (Schweizerische Pharmakopöekommission). In the interests of patient safety, the revised Chapters 17.1 and 17.2 now available are based on the current labelling requirements for authorized medicinal products as stipulated in the Medicinal Products Authorization Ordinance and the Complementary and Herbal Medicinal Products Authorization Ordinance.
For more information, see here.
For further information about the revised Chapters 17.1 and 17.2 see here.