05. Notification of a new representative – applies to all types of authorisation procedures

The same application form shall be used when notifying a new representative 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.

If the application covers two or more medicinal products only one form needs to be filled out if the application only relates to nationally authorised medicinal products. If the application also covers DCP, MRP and centrally authorised medicinal products a separate form must be completed for each procedure, where one form for two or more medicinal products is also sufficient.

The concerned medicinal products can either be listed in the appropriate places on the form itself or a reference can be made to an annex to the form, in which case the annex must contain all the information stipulated in the application form.

Along with the notification of a new representative there shall be a proposal for an updated PIL for nationally, DCP and MRP authorised medicinal products, in accordance with general rules. A mock-up of an updated PIL, as well as updated packages, if applicable, shall be sent to IMA, when available, but still within the time-limit set out in the formal letter from the Agency.

It is anticipated that PILs for centrally authorised medicinal products will be updated in connection with the EU Commission´s update of the same information and then consequently a mock-up would be sent to the Agency.

The MAH shall send the above-mentioned application to the Agency, but in case somebody else does it a statement from the MAH shall be appended to the application specifying who is authorised to apply for the change and which change it covers. The application must have reached the Agency at least one month prior to the anticipated change to come into effect.

Last updated: December 17, 2021
Var efnið hjálplegt Yes No

Hvað þarf að laga?