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 Medicines Agency (DKMA) does post marketing control instead of pre-assessing mock-ups.

A mock-up assessment cooperation by the concerned agencies can be requested using the form below. The cooperation by the Nordic agencies is possible for marketing authorisation (MA) / registration and for major mock-ups changes in variation applications/renewals/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 / registration 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 in one e-mail to all concerned agencies. Please note that DKMA should not be included in the e-mail.

-  FI: The variation application/notification should be additionally sent by electronic submission (preferably via CESP)

-  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

E-mail addresses:

SE

NO

FI (hum)

FI (vet)

IS

Request for a Nordic mock- up cooperation for a marketing authorisation/ registration 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/ registration number in each country, e.g. 11111 (SE)
MAH / registration holder details:
Name / Address
Postal code / City and country
Description:
Marketing authorisation/ registration 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