Explanatory note – letter of representation under Article 31 of Directive 2001/83/EC

Each legal entity involved in a referral procedure under Article 31 of Directive 2001/83 is required to provide a letter of representation to the European Medicines Agency.

The objective of the letter of representation is to formally appoint the person who will legally represent the legal entity (marketing authorisation holder (MAH)) in the referral procedure.

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