Estimated processing times

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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.