Allocation of time slots (DCP)

Updated 30 June 2016

In order to best meet applicants’ requests for specified submission dates and to optimise our own use of time and resources, future applicants are advised to request time slots for their application(s) within a reasonable time prior to the proposed application date.

Time slots will only be allocated to applications for new marketing authorisations (including line extensions) through the decentralised procedure (DCP) where Denmark is acting as reference member state (RMS).

Other types of marketing authorisation applications can, unless otherwise indicated, be submitted without a time slot agreement.

Current status

Time slots may be requested at any time and there are currently no restrictions on the choice of time period. However, we recommend that the requests are limited to no longer than 1½ years from the date of the request.

Time slots are allocated on a “first come first served” basis. If the requested time slot is not available, we will suggest a suitable alternative.

General information about time slots

Time slot requests for any given period must be submitted by interested applicants to the Danish Medicines Agency.

  • Requests should be made by filling in the form: Request for RMS in a decentralised procedure, medicinal products for human use (doc - 0,11 MB). The completed form should then be sent as an attachment to god-validering@dkma.dk. We aim to process your request within 14 days of receipt.
  • The enclosed form must contain all relevant details.
  • To avoid double bookings and to ensure as reasonable a distribution of time slots as possible, we reserve the right to exchange the submitted request information and awarded time slots with medicines agencies from other potential Reference Member States.

Mutual recognition procedures (MRP) including repeat use procedures (RUP) with Denmark as RMS

It is no longer necessary to request a time slot for these procedures. The applicant should be aware that before starting such a procedure, the Danish Medicines Agency is required to update the assessment report. The expected time for these updates can be obtained using the contact details below.

Additional information on updating of assessment reports before an MRP procedure

News

We recommend that you keep abreast of changes made to this website by subscribing to our newsletter

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.


;