The minimal versions contain only the section titles and subsection headings required by the Therapeutic Products Licensing Requirements Ordinance (TPLRO).By contrast, the versions with explanations contain a large number of additional text elements, which are categorised and described below.
Text element types used in the templates with explanations and their status
None of the text elements in the templates with explanations are new content requirements; they are either prescribed wording from the TPLRO or requirements or suggestions from Swissmedic guidance documents. The Swissmedic templates are thus primarily a formal innovation.
Wording prescribed by the TPLRO must always be adopted word-for-word, for example the introduction and closing remarks to the different sections in the Patient information, the note on reporting side effects in the Information for healthcare professionals and the “black triangle” text.
Text requirements that are not from the TPLRO, but from Swissmedic guidance documents – for example the warning regarding children, storage instructions, note on narcotics and information on the traceability of biotech medicinal products – must be adopted substantively. However, adequate justification must be provided for any deviations from requirements.
The remaining texts and subheadings in the templates should simply be regarded as suggestions, for example the subsection headings in the “Dosage/Administration”, “Interactions”, “Undesirable effects” and “Preclinical data” sections of Information for healthcare professionals, and the wording on use during pregnancy and lactation. These text elements can be used when drafting new texts (provided they are suitable); however, they are generally not relevant when transferring existing texts to Swissmedic's templates.
Protected subsections
Subsection headings prescribed by the TPLRO – for example “Absorption”, “Distribution”, etc. – are write-protected in the template for Information for healthcare professionals. These subsections must always be retained. If no text has as yet been approved for such subsections, this fact must be mentioned in an appropriate form, for example “No information available”, “No data available”, “Not relevant to...”, “Not applicable”, etc. The addition of new data is subject to the submission of an appropriate application (type II, C.I.4) and the modification of the order of information or subsections in approved texts (type IB, A.100).
Exceptions to the above requirement are appropriate in the following cases and will be accepted:
The “Properties/Effects” and “Pharmacokinetics” sections of the Information for healthcare professionals for medicinal products authorised as KAS without innovation or as biosimilars must always be identical to the corresponding text for the reference medicinal product/preparation. In such cases the protected subsections in the Swissmedic template should be deleted.