Revision of the guidance document Formal requirements

Clarification of the submission formats (PDF documents), modified requirements for information for healthcare professionals and/or package leaflets associated with export licences for veterinary medicinal products, and revised parallel import requirements necessitate a revision of the guidance document Formal requirements

PDF documents that form part of the authorisation documentation must be generated using OCR (Optical Character Recognition) and may not exceed 200 MB in size (as previously required in the eDok Guidance document). For human medicinal products, PDF documents with more than 20 pages must possess a document structure with useful bookmarks. This and other requirements can be found in section 2.1 Submission formats of the guidance document Formal requirements.

The following was added for veterinary medicinal products: the requirements regarding the need for producing an information for healthcare professionals and/or a package leaflet are independent of whether a main authorisation or an export licence is involved. To this end, section 2.5.3.2 Requirements of the guidance document Formal requirements was revised accordingly. The corresponding requirements in the guidance document Product information for veterinary medicinal products will also be revised.

In section 2.5.10 Information on the bioequivalence trial / reference product, a note to the effect that, as regards the criteria for proving the comparability of a foreign comparator medicinal product with the Swiss reference product, the requirements specified in section 6.3.6 of the guidance document Authorisation of human medicinal product with known active substance apply, was added as information on pharmaceutical bridging.

For parallel imports, a GDP certificate no longer needs to be submitted for the foreign manufacturer in the country of export. The need to submit manufacturing licences for foreign repackaging companies does not apply if Swiss packs are produced. Instead of a GMP certificate for the repackaging process, official documentation can be submitted for the foreign repackaging company confirming that the manufacturers satisfy the PIC/S GMP requirements (inspection report with details of the last inspection). Section 3.22.6 Parallel import of the guidance document Formal requirements includes these requirements.

Swissmedic has revised the guidance document Formal requirements accordingly, and this will enter into force on 1 September 2025.