The same application form shall be used when applying for a transfer of a marketing authorisation to a third party as for changes to the terms of a marketing authorisation. General provisions apply when filling out the form, except that stating the type of application or submitting a checklist is not required.
In order to support an application for an approval of a new marketing authorisation holder (MAH) a signed statement shall be submitted from competent representatives of the current as well as the prospective MAH (the same form may be used), as well as an updated SmPC and PIL, in accordance with general rules. Mock-up of an updated PIL, as well as updated packages shall be sent to the IMA, when available, but still within the time-limit set out in a formal letter from the Agency.
The statement shall include the date from which the new MAH takes over all duties related to the medicinal product, i.e. from the date the transfer of the marketing authorisation comes into effect.
If the prospective MAH does not have a medicinal product with a marketing authorisation in Iceland, a description of the MAH´s pharmacovigilance system shall also be supplied. The statement should also contain the name of an Icelandic representative of the new MAH as well as of a wholesale distributor for the Icelandic market (if applicable).