Local representative

What is the role of the local representative?

The role of the local representative has not been defined. The responsibilities and obligations belonging to the local representative can be agreed between the marketing authorisation holder and the party acting as the local representative.

 

What is the difference between the local representative and the marketer?

The roles of the local representative and the marketer have not been defined. The responsibilities, the obligations and the used terms can be agreed between the marketing authorisation holder and the party acting as the local representative/marketer.

 

Can the local representative be mentioned in the mock-ups of a medicinal product?

It is not recommended to mention the local representative or the marketer in the mock-ups because the size of the package for a medicinal product is limited. If the local representative is mentioned in the mock-ups, the details of the local representative must be separated from the details of the marketing authorisation holder by a heading and they must not affect the readability of the packaging. If the local representative is mentioned on the package, then it must also be mentioned on the package leaflet.

 

Can the local representative be mentioned in the package leaflet?

Yes. The local representative can be mentioned at the end of the package leaflet, but the information must have a clear heading. The same information should be provided at the end of the Finnish and Swedish versions of the text.

 

What kind of information on the local representative must be given in the package leaflet and in the mock-ups?

It is recommended that, in addition to the name, also the contact details of the local representative are mentioned in the package leaflet so that the party in question can be contacted by phone or email. The address can also be mentioned. A website address must not be mentioned.

The name or the logo of the local representative is sufficient in the mock-ups. Also see the question “Can the local representative be mentioned in the mock-ups of a medicinal product”?

 

Must Fimea be informed about the local representative?

Fimea does not need to be informed about the local representative unless the local representative is mentioned in the package leaflet or in the mock-ups of the product.

 

How can the details of the local representative be changed?

The details of the local representative can be changed in the package leaflet (and in the mock-ups as necessary) by submitting a 90-day notification in the case of medicinal products intended for human use and a Type IAin variation application (C.II.6) in the case of veterinary medicinal products. The change can also be made in connection with an application for a Type IB or Type II variation that affects the texts. With type IA/IAin variation applications, the change can only be made to those documents that are updated with the application anyway.

 

Does the local representative act as the marketing authorisation holder’s contact person in communication with Fimea?

The local representative may act as the marketing authorisation holder’s contact person in communication with Fimea. In that case, in addition to the package leaflet, the details of the local representative should also be submitted to Fimea by using the official form “Contact details - communication between marketing authorisation holder and Fimea”, which can be found on Fimea’s website. The contact person for the medicinal product may also be a party that is not the local representative.