Type of regulatory submission / activity (e.g. initial, variation, renewal). Regionally defined.
| Term | Code | Agency | Status |
|---|---|---|---|
| New Active Substance | 100001 | SwissMedic | — |
| Known Active Substance | 100002 | SwissMedic | — |
| Co-Marketing Medicinal Product | 100003 | SwissMedic | — |
| Parallel Import | 100004 | SwissMedic | — |
| Type IA Variation | 100005 | SwissMedic | — |
| Type IA Variation for immediate notification | 100006 | SwissMedic | — |
| Type IB Variation | 100007 | SwissMedic | — |
| Type II Variation | 100008 | SwissMedic | — |
| Extension | 100009 | SwissMedic | — |
| Prolongation, renouncement of prolongation of Marketing Authorisation, notification of no marketing or interruption to distribution | 100010 | SwissMedic | — |
| Follow-up Measure | 100011 | SwissMedic | — |
| Periodic Safety Update Report | 100012 | SwissMedic | — |
| Withdrawal | 100013 | SwissMedic | — |
| Transfer of Marketing Authorisation, Change of name of applicant, change of address of applicant | 100014 | SwissMedic | — |
| Drug Master File | 100015 | SwissMedic | — |
| Plasma Master File | 100016 | SwissMedic | — |
| Application for recognition of orphan drug status or fast track status | 100017 | SwissMedic | — |
| Advice | 100018 | SwissMedic | — |
| No regulatory activity | 100019 | SwissMedic | — |
19 terms shown for SwissMedic. Data sourced from public health authority publications and updated periodically.