Nordic Market for Medicinal Products

Tilgjengelighet av legemidler kan være et problem i små markeder som de nordiske landene. Etter initiativ fra de nordiske helseministrene, er det etablert en arbeidsgruppe som skal se på muligheten for et felles nordisk marked for legemidler. Gruppen har startet et pilotprosjekt, der Sverige og Island deltar. Dette kan være av interesse for søkere av markedsføringstillatelse.

First step

- Iceland and Sweden in a pilot project -

 

Availability of medicinal products is an issue in small markets in EEA. Task forces on behalf of Heads of Medicines Agencies have been looking into availability problems for both veterinary and human medicinal products and possible solutions. Non-availability of medicinal products has also been discussed at the meeting of the Nordic Council´s Ministers of Health. Consequently a Nordic working group was established to explore the possibility of a common Nordic market for medicinal products. The working group has decided to start a pilot project with the participation of Iceland and Sweden. This project comprises cooperation with regard to Mutual recognition and Decentralised procedures. When Sweden, as a Reference Member State, receives an MRP/DCP request the applicant will be approached and asked to add Iceland to the procedure if Iceland is not already a Concerned Member State. The project will be reviewed after six months. The cooperation between Iceland and Sweden preempts that the Icelandic Authorities will fully accept the Swedish assessment of the application. The contact person for such an application at the Icelandic Medicines Control Agency is Mrs. Thorbjorg Kjartansdottir, email address: thorbjorg.kjartansdottir@imca.is and contact person at the Medical Products Agency in Sweden is Ms. Caroline Håkansson, email address: caroline.hakansson@mpa.se.

 

The members of the Nordic working group are:

Rannveig Gunnarsdóttir, Iceland, chairman,
Ingolf J. Petersen, Iceland,
Anna Skat Nielsen, Denmark,
Mette Aaboe Hansen, Denmark,
Paul Schüder, Denmark,
Pekka Järvinen, Finland,
Gro Ramsten Wesenberg, Norway,
Christer Backman, Sweden.

Sist gjennomgått: 05.02.2008
Første gang publisert: 05.02.2008