In this post, information is provided on the following updated guidance documents:
- Time limits for authorisation applications (for new authorisation of medicinal products with known active substances without innovation)
- Formal requirements (concerning information for healthcare professionals and revised parallel import requirements)
- Product information for human medicinal products (disposal information to be added to Patient information
Changes to the guidance document Time limits for authorisation applications
Swissmedic is shortening the procedural time limits for applications for new authorisation of medicinal products with known active substances without innovation (KAS w/o innovation) under Art. 13 TPA.
- This change is part of the continuous development of the procedure under Art. 13 TPA.
- The new time limits shorten the procedure for applications for new authorisation of KAS w/o innovation under Art. 13 TPA by a total of 195 days.
- The new procedural time limits will help further enhance the appeal of applications for authorisation under Art. 13 TPA.
- Swissmedic has revised the guidance document Time limits for authorisation applications accordingly.
- The new time limits for applications for new authorisation of KAS w/o innovation under Art. 13 TPA take effect on 1 September 2025.
Source: Swissmedic
Revision of the guidance document Formal requirements
The following have necessitated a revision of the guidance document Formal requirements.
- Clarification on the submission formats (PDF documents)
- 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.
- Revised parallel import requirements necessitate a revision of the guidance document Formal requirements
- 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 comes into force on 1 September 2025.
Source: Swissmedic
Change to the Guidance document Product information for human medicinal products
In the interests of environmental protection, information on the correct disposal of medicinal products will be added to Patient information from 1 September 2025. The aim is to prevent medicinal product residues entering and polluting the environment.
The information will be phrased as follows:
“Do not throw away any medicines via wastewater or household waste. Expired or no longer needed medicines from households can be returned to pharmacies or collection points.
These measures will help protect the environment.”
- This addition to Patient information is intended to make patients aware that the need for a responsible approach to medicinal products extends to the end of their life cycle too. Disposing of medicinal products correctly is a simple but effective contribution to environmental protection.
- Marketing authorisation holders are requested to implement this requirement voluntarily at the next possible opportunity.
- The revised Guidance document Product information for human medicinal products is valid with effect from 1 September 2025.
Source: Swissmedic