A marketing authorisation or parallel import licence may be transferred from the existing authorisation/licence holder to another holder using a transfer procedure. A transfer may occur before a product is authorised or after authorisation, to a company related to the existing holder or to an unrelated company.
The transfer procedure must be used where the legal entity of an authorisation/licence holder is changed as (P)PA [(Parallel)Product Authorisation] product authorisations are transferred to a new company number.
Using the administrative procedure described in the Guide to Transfers of Product Authorisations and Parallel Product Authorisations, an MA/licence can be transferred within 6 weeks.
Application forms are available for applications made before authorisation and for transfer of an authorised product. Click on the links below:
Transfer of an authorised medicinal product - Application Form A
Transfer of Medicinal Product Application before authorisation - Application Form B
Transfer applications are subject to the national procedure, even if the product has been authorised via the mutual recognition procedure.