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30.11.2012

Finnish Medicines Agency revises Regulation concerning clinical trials on medicinal products

Finnish Medicines Agency´s Administrative Regulation 2/2012 enters into force on 1 December 2012, replacing earlier Regulation 1/2007. The overall substance of the Regulation remains unchanged.

Following changes are done:

  • The Investigator’s Brochure must be validated/updated annually (Directive 2005/28/EC of the European Commission).
  • The data elements in reports to be made of unexpected serious adverse reactions (SUSARs) have been adjusted (Note for guidance - EudraVigilance Human - Processing of safety messages and individual case safety reports (ICSRs) EMA/H/20665/04/Final Rev. 2).
  • The requirement concerning annual safety reporting (list of suspicion of serious adverse reactions and a report signed by the person responsible for a trial on the safety of persons participating in a clinical trial has been specified to be in force throughout the period a trial is in progress in Finland (Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use 2011/C 172/01 (CT-3)).
  • Plasma-derived medicinal products used in a clinical trial on medicinal products have been added to the sphere of Fimea’s batch-specific release.
  • The data concerning preclinical studies as well as investigational medicinal product has been revised to correspond to the regulations in force.

Certain minor adjustment and clarification has been made to the Regulation in other respects as well.

Read more:

Määräys 2/2012 in Finnish
Unofficial translation of the Regulation in English will be published later on Fimea’s web page.

Further information:

Johanna Honkalammi, Senior Medical Officer, tel. +358 29 522 3331
Esko Nuotto, Head of Unit, tel. +358 29 522 3350

E-mail address format: firstname.lastname@fimea.fi.