Routes of the same type are on the same row. Compare other markets.
15 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, well-established use, non-prescription application and more. The table lines up the routes of each type.
Switzerland: Ordinary authorization of a medicine with a new active substance, 330 days. Netherlands: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | Switzerland | Netherlands |
|---|---|---|
| Full application, new active substance | Ordinary authorization of a medicine with a new active substanceArt. 11 HMG · target 330 days · fee CHF 80,000 | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 |
| Full or mixed application, known active substance |
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
Centralised marketing authorisation, known active substance or new fixed combinationtarget 210 days · fee €690,700 Centralised hybrid applicationtarget 210 days · fee €426,100 |
| Generic application | Simplified authorization of a generic (known active substance without innovation)Art. 14 Abs. 1 Bst. a HMG; Art. 12-14 VAZV · target 330 days · fee CHF 15,000 | National generic or hybrid applicationfee €37,290 Centralised generic applicationtarget 210 days · fee €177,900 |
| Biosimilar application | Authorization of a biosimilarArt. 4 Abs. 1 Bst. anovies HMG · target 330 days · fee CHF 50,000 · relies on EU, US | Centralised biosimilar applicationtarget 210 days · fee €732,400 |
| Well-established use | Simplified authorization for active substances used for ten years in the EU or EFTAArt. 14 Abs. 1 Bst. abis HMG; Art. 17a-17b VAZV · target 330 days · relies on EU Simplified authorization for long-used non-prescription medicinesArt. 14 Abs. 1 Bst. ater HMG; Art. 17c VAZV · target 330 days · relies on EU | Centralised well-established use applicationtarget 210 days · fee €780,900 |
| Non-prescription application | Non-prescription status: dispensing category and switchArt. 23-23a HMG; Art. 40-44 VAM · target 270 days |
| Traditional or herbal registration | Simplified authorization of herbal and complementary medicinesArt. 14 Abs. 1 Bst. b und cbis HMG · target 120 days · fee CHF 3,000 | Traditional herbal medicine registrationfee €5,670 |
| Conditional or accelerated approval | Temporary authorization (incomplete data)Art. 9a HMG; Art. 18-22 VAZV · target 140 days · fee CHF 80,000 | Conditional marketing authorisationtarget 210 days |
| Approval under exceptional circumstances | - | Authorisation under exceptional circumstancestarget 210 days |
| Priority or accelerated review | Fast-track authorization procedureArt. 7 VAM · target 140 days | Accelerated assessmenttarget 150 days |
| Intensive development support designation | - |
| Orphan or rare disease designation | Orphan drug status (important medicine for a rare disease)Art. 4 Abs. 1 Bst. adecies HMG; Art. 4-5 VAZV · target 210 days · relies on EU, US | Orphan designationtarget 90 days |
| Pediatric plan or incentive | Pediatric investigation plan and pediatric incentivesArt. 54a HMG; Art. 5 VAM | Paediatric investigation plantarget 60 days |
| Early or compassionate access | Exceptional authorization of a device without conformity assessmentArt. 22 MepV; Art. 18 IvDV | Supply on physician statement (named patient)Gmw Art. 40(3)(c) |
| Reliance route, abridged review | Authorization based on a foreign authorization (Article 13 procedure)Art. 13 HMG; Art. 16-20 VAM · target 195 days · fee CHF 15,000 · relies on EU, US, GB, CA, AU, JP, SG | - |
| Reliance route, recognition or verification | - | Mutual recognition and repeat use: Dutch steps and feesNL/H/xxxx/xxx/MR · fee €31,990 Licence for public health reasons (product marketed elsewhere in the EU)Gmw Art. 52 · relies on EU Mutual recognition proceduretarget 90 days |
| Work-sharing or joint review | - | Decentralised procedure: Dutch steps and feesNL/H/xxxx/xx/DC · fee €102,640 Decentralised proceduretarget 210 days |
| Device: exempt or self-declared | - |
| Device: conformity assessment by a certification body | Medical device conformity assessment and placing on the marketArt. 45-47 HMG; MepV · relies on EU In vitro diagnostic device conformity assessment and placing on the marketIvDV · relies on EU |
| Device: registration or licence with the regulator | Registration of device economic operators and productsArt. 47 HMG; Art. 17 and 55 MepV |
| Other route | Procedure with prior notification (20 percent shorter review for a double fee)Art. 7 GebV-Swissmedic · target 264 days Simplified authorization for a parallel importArt. 14 Abs. 2 und 3 HMG · target 330 days · fee CHF 4,000 | Informed consent applicationArt. 10c Directive 2001/83/EC · fee €9,380 Duplex marketing authorisationfee €9,380 Homeopathic medicine registrationfee €3,890 Parallel import licenceRVG2//RVG1 · fee €2,600 Temporary import exemption during shortagesRegeling Gmw Art. 3.17a · relies on EU, GB Hospital exemption for advanced therapy medicinesGmw Art. 40(3)(d) Integral drug-device combination authorised as a medicinetarget 210 days |