Letter of Authorisation

In case the communication between the applicant/marketing authorisation holder (MAH) and the agency is to be carried out by a third party (e.g. a consultant), Power of Attorney (Letter of Authorisation) must be presented once the third party contacts the agency.

For new applications in which the marketing authorisation holder is represented by a consultant or a subsidiary/group partner with a different registered office, we need a LoA for the procedure (during procedure) and, if necessary, one for after procedure.

The Power of Attorney should comprise:

  • name and address of the applicant/MAH
  • name and address of the third party
  • entitlements of the third party
  • declaration if the Power of Attorney is of general nature (concerning all products) or concerns only a specific product (state the MRP/DCP number)
  • duration of validity of the Power of Attorney
  • signature of an authorised signatory of the applicant/MAH