Finland Label Text

By Lori Richards posted 01-Mar-2013 14:33

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I am trying to find out the National Regulations for Finland with regard to label text language. The study is a multinational study and the dosing will take place at a hospital, the patient will not take the study drug home. Does the regulations in Finland require the label text to be in Swedish and Finnish or is English acceptable? Any help will be appreciated.

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Katia Toebosch

19-Mar-2013 08:30

In Finland, all labeling and IFU should be in Finnish. There is no requirement regarding the use of single or multiple-language labeling.
for Label and Display: Finnish, Swedish or English for professional use ; Finnish and Swedish for public use.
for Safety Instruction: Finnish and Swedish
for IFU: Finnish, Swedish or English for professional use ; Finnish and Swedish for public use.
Language
In accordance with Article 56 and 63 (1) of Directive 2001/83/EC as amended, the
labelling must be presented at least in the language or languages of the Member State(s)
where the product is placed on the market. If more than one language is used, then all of
the text must be in each language and the overall readability should not be adversely
affected. The content of all language versions must be identical. It is recommended to
group different text elements for each language, where appropriate.

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