Swissmedic licence
F. Hoffmann-La Roche AG Klinische Versuchspräparate ATMP
Swissmedic licence 512286-102758772 · Kaiseraugst · COMPLIANT
Key facts
| Authorization number | 512286-102758772 |
|---|---|
| Licence holder | F. Hoffmann-La Roche AG |
| Site | F. Hoffmann-La Roche AG Klinische Versuchspräparate ATMP |
| City | Kaiseraugst |
| Canton | AG |
| Country | Switzerland |
| Compliance status | COMPLIANT |
| Last inspection | Jun 11, 2025 |
| Valid until | Indefinite |
| Manufacturing activities | 1 MANUFACTURE OF TpP / GT / GMO, 1.3.2 Batch certification (technical release), 1.3.2.8 Other TpP / GT / GMO low bioburden and sterile oligonucleotide, RNA, sgRNA and siRNA (I), 1.5 Packaging of TpP / GT / GMO products, 1.5.2 Secondary packing (I) |
| Wholesale activities | ST.4 wholesale distribution OF TpP / GT / GMO, ST.4.4 wholesale distribution of ready-to-use GT/GMO products, ST.4.4.2 excluding market release (I), ST.4.4.6 Other: low bioburden and sterile oligonucleotide, RNA, sgRNA and siRNA (I) |
| Import activities | ST.2 IMPORT OF TpP / GT / GMO, ST.2.4 Import of ready-to-use GT/GMO products, ST.2.4.2 excluding market release (I), ST.2.4.6 Other: low bioburden and sterile oligonucleotide, RNA, sgRNA and siRNA (I), ST.2.5 The import of ready-to-use TpP/GT/GMO, excluding market release, is restricted to:, ST.2.5.4 the import of TpP/GT/GMO for clinical trials on behalf of the sponsor for subsequent distribution to the trial centres (I), ST.2.5.5 Other: Importation of viral vectors for clinical trials (I) |
| Record type | Transplant Products |
| Swissmedic record | swissgmdp.ch |
At a glance
- Yes Licence active
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About Swissmedic establishment licences
Swissmedic licenses establishments that manufacture, import, export or distribute medicinal products in Switzerland and records their GMP/GDP compliance status.