Malta as Reference Member State in the Decentralised Procedure

Since 2007 the Medicines Authority is accepting applications as Reference Member State in the Decentralised Procedure.

Until further notice, the applications considered will be those for solid oral dosage forms and oral solutions in accordance with article 10 of Directive 2001/83/EC, as amended.

To be able to consider such applications, some information is requested to enable the Medicines Authority to assess whether to accept the submission of an application for a Marketing Authorisation or not. The Request Form on the CMDh website should be filled in and sent to the Medicines Authority at least 6 months before the proposed submission date. The requests should be sent by e-mail directly to the CMDh (MRP/DCP) contact point with a copy to the e-mail address This email address is being protected from spambots. You need JavaScript enabled to view it..

The slots for the 20 procedures planned for 2010 are all booked. A few procedures are on the waiting list should slots become available in case of cancellation by the applicants.

Currently the Medicines Authority is filling in slots for 2011 - 2012. Please send in the pre-submission forms in due time for consideration, at least six months before proposed submission date. Once you are given a slot, you are requested to inform the Medicines Authority immediately should you not be able for any reason to submit in the agreed timeline. The Medicines Authority should be informed in good time about any problems encountered that may lead to postponement or cancellation of the slot that is granted.

Information and guidance documents on the decentralised procedure can be found on the CMDh website.

Public assessment reports of products authorised with procedures where Malta is RMS are being made available on http://www.medicinesauthority.gov.mt/par.html

Information source: www.medicinesauthority.gov.mt

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