Estimated processing times

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.