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Transcript
NOTIFICATION OF CANCELLING A
MARKETING AUTHORISATION
The marketing authorisation or registration holder or a person or
company authorised by the holder should submit a written
notification before the end of the authorisation year if the
authorisation is to be cancelled and the annual fee left unpaid.
(Finnish Medicines Agency Fimea administrative regulation
2/2013, Applying for and maintaining a marketing authorisation
and registration for a medicinal product / section 7.2.1 Cancelling a
marketing authorisation or registration.)
THE MARKETING AUTHORISATION IS TO BE CANCELLED STARTING FROM THE FOLLOWING DATE
Year
Month
Day
Type of medicinal product/preparation
Human medicine
Veterinary medicine
Herbal medicinal product
Parallel imported product
PRODUCT DETAILS
Marketing authorisation number
Name of the medicinal product
Strength
Pharmaceutical form
Marketing authorisation holder
CONTACT DETAILS FOR THE SENDER
Company name
Surname
First name
Address
Phone
Fax
E-mail address
Fimea 5.2014
Other comments
DATE AND SIGNATURE
Date
Signature
NB. A single form can be used for the cancellation of several marketing authorisations, provided that all the marketing authorisations
listed in the form have the same cancellation date.
The marketing authorisation cancellation form is available at the Finnish Medicines Agency Fimea website at the following address:
http://www.fimea.fi/lomakkeet
The signed marketing authorisation cancellation form should be submitted without delay to the following address:
Finnish Medicines Agency
PO Box 55
FI-00034 FIMEA, FINLAND
Fax +358 29 522 3014
Lääkealan turvallisuus- ja kehittämiskeskus | Säkerhets- och utvecklingscentret för läkemedelsområdet | Finnish Medicines Agency
P.O.Box 55, FI-00034 FIMEA, FINLAND | Tel. +358 29 522 3341 | [email protected] | www.fimea.fi | Business ID: 0921536-6