Available time slots in Q1 2015 for DCP applications with Denmark as reference member state

14 November 2014

Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available in the first quarter of 2015.

Time slots for DCP procedures with Denmark as reference member state (RMS)

Allocation of time slots is only an option for companies submitting applications via the decentralised procedure (DCP) with Denmark as RMS.

More information on time slots and how to request a time slot is available under Allocation of time slots.

Four procedures for authorisation of medicinal products

The decentralised procedure is one of the four procedures that pharmaceutical companies can use when applying for authorisation to sell a medicinal product in Denmark and the EU/EEA. The other procedures are described under Marketing authorisation for a medicine

Under the decentralised procedure, pharmaceutical companies apply for authorisation of medicinal products in several EU or EEA countries at the same time. The decentralised procedure can only be used if a national authorisation has not been obtained in an EU or EEA country.

The reference member state is responsible for the procedure and the professional assessment of the application.

How to apply for a time slot

Companies can request a time slot by filling in and submitting the form on this page Allocation of time slotsPlease send the form to god-valdering@dkma.dk

We aim at replying to requests and offer any available time slot one to three working days after we have received the form.

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