Estimated processing times for administrative decisions at the Finnish Medicines Agency Fimea
Matters referred to in the Medicines Act (395/1987)
| Matter |
Estimated processing time |
| Matters concerning the classification of a substance or a product as a medicine |
3 months |
| Permit for multidose drug dispensing and contract manufacturing |
3 months |
| Pharmacy licence |
3 months |
| Subsidiary pharmacy licence |
3 months |
| Pharmacy service point licence |
4 months |
| Appointment of a temporary pharmacy manager by application |
2 weeks |
| Hospital pharmacy licence or dispensary licence |
3 months |
| Permission under section 62 of the Medicines Act to supply medicines (so-called institutional licence) |
3 months |
| Approval as a test laboratory |
3 months |
The estimated processing time for pharmacy and subsidiary pharmacy licences is calculated from the end of the application period.
Matters referred to in the Act on the Medical Use of Human Organs, Tissues and Cells (101/2001)
| Matter |
Estimated processing time |
| Tissue establishment licence |
3 months |
Matters referred to in the Blood Service Act (197/2005)
| Matter |
Estimated processing time |
| Blood service licence |
3 months |
Matters referred to in the Act on Obligatory Reserve Supplies of Medicinal Products (979/2008)
| Matter |
Estimated processing time |
| Special arrangements for the fulfilment of the obligation to maintain mandatory reserve supplies |
1 month |
| Releasing an entity from obligation |
1 month |
| Permission to maintain lower stock levels |
2 weeks |
Matters referred to in the Narcotics Act (373/2008)
| Matter |
Estimated processing time |
| Authorisations referred to in Chapter 2 of the Narcotics Act |
2 weeks |
All processing times given above are estimates. Any need to supplement applications or to request further clarification will affect the processing time.