Swissmedic Guidances: Strengthening Regulatory Clarity for Medicinal Products
- Sharan Murugan
- Sep 7
- 2 min read
On 1 September 2025, Swissmedic published a set of updated guidance documents that refine requirements for medicinal product authorisations, product information, parallel imports, renewals, and variations. These updates aim to improve transparency, harmonisation with international practices, and regulatory predictability for both human and veterinary medicinal products. Below is an overview of the key guidance documents released.
This updated guidance provides detailed instructions for preparing Information for Healthcare Professionals (IHP) and Patient Information (PI).
Key highlights include:
Standardised templates for healthcare professional and patient leaflets.
Black triangle labelling for products under additional monitoring.
Clear rules for temporary authorisations and how they must be presented in product texts.
Requirements for language use, including official Swiss languages and gender-neutral phrasing.
Specific provisions for radiopharmaceuticals, phytotherapeutics, complementary, and Asian medicines.
By aligning with EMA and FDA standards, Swissmedic strengthens international consistency in product information.
This guidance clarifies the simplified procedure for authorising parallel imports of human medicinal products under Art. 14 para. 2 and 3 TPA.
Key aspects:
Parallel imports must come from countries with comparable medicinal product control.
Products must meet the same safety, quality, and labelling requirements as the Swiss reference product.
Rules for packaging adaptations (primary and secondary packaging) and labelling consistency.
Ongoing obligations such as pharmacovigilance, variations, and handling of recalls or suspensions.
This update helps maintain patient safety while allowing market flexibility and price competition.
This guidance sets out the rules for renewals, discontinuations, and conversions between main authorisations and export licences.
Highlights:
Standard five-year initial authorisation period, after which renewal leads to unlimited validity.
Rules for temporary authorisations (usually two years) with conditions for conversion to standard approvals.
Procedures for voluntary discontinuation of authorisation or withdrawal of specific dosage strengths/pack sizes.
Mechanisms for status conversion between main authorisation and export licence, particularly relevant for co-marketed products.
This ensures regulatory clarity across the full product lifecycle.
This guidance sets clear processing timeframes for different types of authorisation applications. It establishes predictable review periods, ensuring that applicants can plan submissions more efficiently. Swissmedic emphasises timely processing while maintaining flexibility for complex dossiers that may require extended review.
For more details, see Swissmedic’s official update page: Swissmedic – Updated Guidance Documents, September 2025
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