Changes to the questions and answers and guidance document on mobile technologies
Swissmedic updated its Q&A and guidance document on mobile technologies.
Swissmedic · SwitzerlandSwissmedic
Regulation
Category
Type
Date
swissdamed: Mandatory registration of medical devices and in vitro diagnostic medical devices as of 1 July 2026
Mandatory registration of medical devices and in vitro diagnostic medical devices in the Swiss registry (swissdamed) enters into force.
Swissmedic · SwitzerlandNew guideline: Swiss Good Practice for Post-Market Surveillance of In-Vitro Diagnostics (GPMV-IVD)
Swissmedic publishes new guideline on post-market surveillance practices for in-vitro diagnostic devices.
Swissmedic · SwitzerlandUpdating of the information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway
Updated guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway.
Swissmedic · SwitzerlandPharmacopoea Helvetica 13 published
The 13th edition of the Swiss Pharmacopoeia entered publication in October 2026, with entry into force scheduled approximately 6 months later, including new monographs for quantified liquorice root fluid extract and Lugol's solutions 1-5%.
Swissmedic · SwitzerlandAdaptations required for issuing establishment licences and GMP certificates for manufacturers of active substances
Swissmedic announces adaptations to requirements for establishment licences and GMP certificates for active substance manufacturers, effective 1 October 2026.
Swissmedic · SwitzerlandGMP compliance by foreign manufacturers
Swissmedic and industry associations clarified GMP assessment procedures for foreign manufacturers in authorisation applications and developed joint solutions.
Swissmedic · SwitzerlandRevision of the Guidance document Authorisation Biosimilar
Swissmedic updates biosimilar authorisation guidance to align with EMA reflection paper on tailored clinical approaches in biosimilar development.
Swissmedic · SwitzerlandChanges to the guidance document RMP ICH E2E information submission HMP
Swissmedic updates guidance on risk management plan information submission under ICH E2E for human medicinal products.
Swissmedic · SwitzerlandChanges to the Guidance document: Import of a human medicinal product according to Art. 14 para. 2 and 3 TPA (parallel import)
Swissmedic clarifies the definition of 'country of export' for parallel imports and tightens primary packaging labelling requirements.
Swissmedic · SwitzerlandEuropean Pharmacopoeia Edition 12.3 enters into force
European Pharmacopoeia Edition 12.3 becomes effective on 1 July 2026.
Swissmedic · SwitzerlandSimplification of applications for a change of status between main authorisation and export licence for veterinary medicinal products
Swissmedic simplifies the application process for changing status between main authorisation and export licence for veterinary medicines, effective 1 September 2026.
Swissmedic · SwitzerlandPatient information and Information for healthcare professionals for human medicinal products: Change to the templates
Templates for patient information and healthcare professional information for human medicinal products are being changed, effective 01.07.2026.
Swissmedic · SwitzerlandNeuroleptic malignant syndrome associated with antipsychotic treatment
Swissmedic alerts to neuroleptic malignant syndrome, a potentially life-threatening adverse reaction to antipsychotic medicines characterised by fever, rigidity, autonomic instability and altered mental status.
Swissmedic · SwitzerlandSwissmedic Journal
The Swissmedic Journal is the official periodical of the Swiss Agency for Therapeutic Products and appears monthly, in German and French. It is published in the middle of the following month on this website. The Swiss...
Swissmedic · SwitzerlandHPC - Librela ad us. vet., injection solution for dogs (Bedinvetmabum)
Marketing authorisation granted for Librela, a veterinary injection solution for dogs.
Swissmedic · SwitzerlandSummary report on authorisation – Serum autolog USZ, eye drops®
Marketing authorisation granted for Serum autolog USZ, eye drops, a pharmaceutical product.
Swissmedic · SwitzerlandSummary report on authorisation – Serum autolog LUKS, eye drops®
Marketing authorisation granted for Serum autolog LUKS, eye drops, a pharmaceutical product.
Swissmedic · SwitzerlandSummary report on authorisation – Serum autolog KSGR, eye drops
Marketing authorisation granted for Serum autolog KSGR, eye drops.
Swissmedic · SwitzerlandOut-of-Stock – Syntocinon Nasal Spray, Solution; Oxytocin 40 I.U./ml
Swissmedic authorises temporary distribution of Syntocinon nasal spray in Norwegian/Swedish packaging to address shortage.
Swissmedic · SwitzerlandBatch recall – Elocom, cutaneous solution
Batch recall issued for Elocom cutaneous solution.
Swissmedic · SwitzerlandOut-of-Stock – Ketazed, Eye Drops Solution
Ketazed eye drops solution is out of stock as of 25 September 2026.
Swissmedic · SwitzerlandSummary report on authorisation – Sérum autologue ICH, eye drops®
Marketing authorisation granted for Sérum autologue ICH, eye drops, a pharmaceutical product.
Swissmedic · SwitzerlandSummary report on authorisation – Sérum autologue HOJG, eye drops
Marketing authorisation granted for Sérum autologue HOJG, eye drops, a pharmaceutical product.
Swissmedic · SwitzerlandSummary report on authorisation – Serum autolog Universitätsspital Basel, eye drops
Marketing authorisation granted for Serum autolog Universitätsspital Basel, eye drops.
Swissmedic · SwitzerlandSummary report on authorisation – Serum autolog Insel, eye drops®
Marketing authorisation granted for Serum autolog Insel, eye drops, a pharmaceutical product.
Swissmedic · SwitzerlandSummary report on authorisation – Serum autolog Blutspende Zürich, eye drops
Marketing authorisation granted for Serum autolog Blutspende Zürich, eye drops.
Swissmedic · SwitzerlandSummary report on authorisation – Ogsiveo®
Marketing authorisation granted for Ogsiveo®.
Swissmedic · SwitzerlandSummary report on authorisation – Abrysvo®
Marketing authorisation granted for Abrysvo®, a respiratory syncytial virus vaccine.
Swissmedic · Switzerland
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