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null Amendment of administrative regulation 1/2009

Amendment of administrative regulation 1/2009

7.10.2011

Amendment of administrative regulation 1/2009

Administrative regulation 1/2009 concerning applying for and maintaining a marketing authorisation and registration for a medicinal product has been amended by administrative regulation 4/2011. Regulation 4/2011 will enter into force on 14 October 2011.



An amendment was made to administrative regulation 1/2009 currently in force by means of regulation 4/2011 on the basis of which the market authorisation holder may apply for a marketing authorisation for a special pack size intended solely for dose-dispensing.



The main content of the amendment is to provide guidelines on a method whereby a special dose-dispensing pack such as this can be applied for.

Read more:

Regulation (pdf)

Instructions (pdf)

Further information:

Marja-Riitta Helle, Head of Unit, tel +358 9 4733 4239



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