| Date |
Information/Topics |
|
30.09.2018 |
Go-live/publication of new specification documents
|
|
25.10.2018 |
Swissmedic information event on the revision of the Therapeutic Products Act (TPA) Thursday 25 October 2018 Morning
- Harmonisation of "variations" with EU variations
- Reallocation of products to dispensing categories
- Transitional rules
- New provisions with regard to Art. 13 TPA
- Implementation of Art. 14 para. 1 let. abis-quater
Afternoon
- Parallel session 1 Paediatric investigation plan, temporary authorisations, document protection and orphan drugs
- Parallel session 2 Rules for veterinary medicinal products
- Parallel session 3 Rules for complementary and herbal medicines
|
Congress Centre Kursaal Bern |
| 01.11.2018 |
Go-live/publication of amended eCTD M1 specifications |
|
09.11.2018 |
Swissmedic information event on the revision of the Therapeutic Products Act (TPA) Friday 9 November 2018 Morning
- Swiss Public Assessment Report (SwissPAR) and Public Summary SwissPAR: publication, receipt of application and authorisation decisions
- Full declaration, new templates for patient information and information for healthcare professionals, black triangle, Italian information for healthcare professionals, publication of product information
- Redesign of forms, Internet lists
Afternoon
- Revision of the Medicinal Products Licensing Ordinance (MPLO): introduction in law
- Revision of MPLO, part 1: definitions, licence types, requirements for RP
- New establishment licences, new GMP/GDP certificates
- Revision of MPLO, part 2: individual import licences, special licences, compassionate use
|
Congress Centre Kursaal Bern |
| 2019 |
Most of the provisions of the TPA and the relevant implementing provisions are to enter into force as originally planned on 1 January 2019. The Federal Council shall determine the date when the provisions come into force. |
|
