Routes of the same type are on the same row. Compare other markets.
11 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, non-prescription application, conditional or accelerated approval and more. The table lines up the routes of each type.
Netherlands: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | Brazil | Netherlands |
|---|---|---|
| Full application, new active substance | Registration of a new medicinefee R$157,416 | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 |
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.
| Full or mixed application, known active substance | Registration of an innovative medicinefee R$37,231 | 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 | Registration of a generic medicinefee R$11,714 Registration of a similar medicinefee R$41,000 | Centralised generic applicationtarget 210 days · fee €177,900 National generic or hybrid applicationfee €37,290 |
| Biosimilar application | Centralised biosimilar applicationtarget 210 days · fee €732,400 |
| Well-established use | - | Centralised well-established use applicationtarget 210 days · fee €780,900 |
| Non-prescription application |
| Non-prescription monograph | - |
| Traditional or herbal registration | - | Traditional herbal medicine registrationfee €5,670 |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days |
| Approval under exceptional circumstances | - | Authorisation under exceptional circumstancestarget 210 days |
| Priority or accelerated review | Accelerated assessmenttarget 150 days |
| Intensive development support designation | - |
| Orphan or rare disease designation | Special procedure for new medicines for rare diseasestarget 60 days | Orphan designationtarget 90 days |
| Pediatric plan or incentive | - | Paediatric investigation plantarget 60 days |
| Early or compassionate access | Supply on physician statement (named patient)Gmw Art. 40(3)(c) |
| Reliance route, abridged review | Optimized analysis using an equivalent foreign authorityrelies on EU, CA, WHO, CH, GB, US, AU, JP Optimized analysis for class III and IV devices approved abroadrelies on AU, CA, US, JP | - |
| 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: premarket notification | Notification of a class I or II medical devicetarget 30 days | - |
| Device: conformity assessment by a certification body | - |
| Device: registration or licence with the regulator | Registration of a class III or IV medical devicetarget 320 days · fee R$39,048 Registration of a class III or IV in vitro diagnostic devicetarget 365 days · fee R$15,619 Software as a medical device (notification or registration)target 250 days |
| Other route | Good manufacturing practice certification (CBPF)target 365 days | 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 |