Nordic Mock-Up Assessment Cooperation

Nordic mock-up assessment cooperation

Mock-up assessment cooperation has been established between the Swedish (MPA), Norwegian (NoMA), Finnish (Fimea) and Icelandic (IMA) medicinal agencies. If two or more of these countries are concerned for your Nordic package, a Nordic mock-up assessment cooperation can be requested. Denmark can also be part of the Nordic package, however, the Danish Health and Medicines Authority does post marketing control instead of pre-assessing mock-ups.

A mock-up assessment cooperation by the concerned agencies can be requested using this form. The cooperation by the Nordic agencies is possible for marketing authorisation (MA) and for major mock-ups changes in variation applications/article 61(3) of Directive 2001/83 notification (hum) or C.II.6 variation according to Commission Regulation No 1234/2008 (vet).

When Nordic packages are planned the planning should be started already before the marketing authorisation application process: The labelling text, including name, strength and legal status, must be the same in all concerned countries.

When requesting mock-up assessment cooperation:

-  The mock-ups (and form) must be submitted simultaneously to all concerned agencies

-  The mock-up cooperation request form should be used

-  The mock-ups must be submitted simultaneously time with SmPC and PL, if applicable

-  The mock-ups should be amended according to the comments made by the agencies

Note that the Nordic cooperation is still at an early stage, thus it cannot be guaranteed that cooperation will be possible for all requests.

E-mail addresses:

SE

NO

FI (hum)

FI (vet)

IS

Request for a Nordic mock- up cooperation for a marketing authorisation procedure/61(3) notification (hum) / C.II.6 variation (vet)
Mock-up(s) sent to (date)
SE / NO / FI / IS
MR/DC procedure
The submitted mock-ups are part of a procedure. Procedure number
Product details:
Product name:
Strength(s): / Pack size(s) / Rx/OTC status / Mock-ups submitted (e.g. carton/blister etc.) / Countries involved / MA number in each country, e.g. 11111 (SE)
MAH details:
Name / Address
Postal code / City and country
Description:
Marketing authorisation application
Major layout change
Other major mock-up change, please clarify:
Appendices
Proposed mock-ups are attached.
Current approved mock-ups are attached.
As requesting company we accept that the involved agencies may communicate and share documentation involved in this application.
Contact person
Name / Company
E-mail / Telephone number
Signature / Date