The further revision of chapters 20 and 21 was undertaken to further clarify the distinction under therapeutic products legislation between manufacture and preparation for administration, and to give the cantons, which are responsible for enforcement of preparation for administration, the necessary scope for the planned creation of practical enforcement aids.
The following revisions have been made:
- Definitions (chapters 20.1, 20.2, 20.3): “Any handling” has been replaced by “handling”. This provides scope for practical distinctions.
- Chapter 21.1.A.2 Scope: The explanations are now limited solely to the scope. Other content has been deleted or moved to other sections. This results in a slightly changed repetition of the regulatory content, which is clearer.
- Chapter 21.1.B Definitions: The language in the explanations has been adapted, and they have been simplified and reduced to principles. Examples have been deleted. This provides the necessary scope for the planned cantonal regulations.
The revised chapters will be incorporated into Ph. Helv. 13, publication of which is planned in October 2026.