Decree on fees chargeable by the Finnish Medicines Agency has been updated

News • 02.04.2014

Finnish Decree of the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency has been updated. New updated decree 252/2014 became effective as of 1 April 2014.

Amendments are mainly related to annual fees, given waiver applications (sunset clause), applications for reduction of storage obligation, and process fees for grouped variations where Finland is the reference member state: 

  New fee Old fee

Change

Type IA grouped variation applications with more than one process (FI/H or V/XXXX/IA/G)

– no separate variation application fee

1,000 € (process fee)

–           

 

Annual fee, human product

1,350 €

1,200 €

+12.5%

Annual fee, parallel import product

680 €

620 €

+9.7%

Waiver application (sunset clause)

100 €

–           

 

Application for reduction of storage obligation

600 €

300 €

+100%

Licence for wholesaling of medicinal products

1,750 €

2,000 €

-12.5%

Registration of persons brokering medicinal products

1,000 €

–           

 

Inspection of medicinal product brokers, 1 day

2,000 €

–           

 

Inspection of medicinal product brokers, additional days

Document inspection of wholesale distribution

Document inspection related to brokering of medicinal products

1,000 €

–           

 

Fees for pharmacy, transplantation centre and donation hospital inspections will also change.

If you need help in classification of variation applications as well as in assessment and preparation of application documentation (including pharmaco-chemical expert reports), do not hesitate to contact .