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Home / Activities / Registration / European Procedures / Decentralised and Mutual Recognition Procedures

Decentralised and Mutual Recognition Procedures

Introduction

In cases where a national marketing authorisation (MA) is required for a product that is already registered in another member state of the EU/EEA the Mutual Recognition (MR) procedure applies. Where a product is not already authorised in another member state,  the Decentralised (DC) procedure may be used for obtaining a Marketing Authorisation (MA) for Malta.  

Guidelines and Application Forms

More detailed information on the MR and DC procedures, guidance documents and all documentation and templates can be found in the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) section  of the Heads of Medicines Agencies (HMA) website.

Details on documentation to be supplied can be found in Volume 2A, Chapter 2 (Mutual Recognition) of the Notice to Applicants and application forms can be downloaded from Volume 2B of the Notice to Applicants of the European Commission website.

Zero-day Mutual Recognition Procedure

The MMA agrees to accept the assessment of the RMS or the National Competent Authority (in the instance where the product had been authorised nationally), without any comments or questions. The approved product information will also be accepted without any comments. The MMA will not request any update of the assessment report or the dossier, nor will there be any changes related to such procedure, except that in this simple way Malta joins an MRP. These procedures can be finalised once the application has been accepted by the RMS and MMA, hence a “MRP day zero procedure”. Procedures have already been finalised successfully with various RMS countries. 

 More information on the Zero day Mutual Recognition Procedure

Applicants should inform the Medicines Authority of their intention to submit such an application to the RMS.  The applicant sends a request to the RMS requesting the use of this simplified procedure.  The RMS requests confirmation from the CMS regarding the criticality of the product applied for.  Please refer to published CMDh guidance document for this procedure.

The CMS confirms the need for the product and guarantees that:

a.      There will be no need for the RMS to update the assessment report since these will be accepted from the RMS without any comments

b.      No CMS comments will be sent by MT as CMS to the RMS thus enabling the application to be approved immediately

c.      The addition of MT will not change the renewal cycle or PSUR submission timelines

d.      The product information specifically the SmPC, package leaflet and labelling will be accepted as authorised in the RMS

e.      No additional renewal is required.

An application form and dossier are submitted to MT as CMS. This submission should include:

a.       A cover letter clearly stating that the submitted dossier is identical to the one currently approved in the RMS and that it is being submitted as a Zero day MR procedure

b.      The dossier preferably in eCTD format as had been submitted to the Reference Member State, together with any subsequent approved variations and a confirmation of their approval (for MRP on the basis of a previously national procedure only).  If the product is already in the MRP the list of approved variations is not required.

c.       Latest approved Product Information approved by the RMS

MT as CMS validates the application form within a 14 day validation period

·         RMS then sets a Day 0

·         A Zero-day procedure is concluded on the same day it starts (i.e. following validation) by the RMS

·         The End Of Procedure documents are sent by the RMS to Malta

·         Following this, the applicant submits the MT specific product information

·         The Medicines Authority issues the MA during the 30 days national phase of the procedure.

Requests for Malta to be included as CMS in Zero day procedures should be sent to the mailbox mrp-dcp.adm@gov.mt as well as any queries on the above or you need guidance and support. 

Malta as Reference Member State in the Decentralised Procedure

Malta is active as Reference Member State, mainly for generic applications.  The Medicines Authority grants slots according to resoures available.  To book a slot for Malta to be the  RMS in a DC or MR Procedure the Request Form available on the CMDh website should be filled in and sent to the Medicines Authority at least six (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 Licensing Directorate's e-mail address.   It is important that the information on this form is as complete and correct as possible.

Public assessment reports of products authorised with procedures where Malta was RMS are available here.

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.

Please note that for companies that submit three applications within a 12 month period for DCP with Malta as Reference Member State, a 30% discount on the full fees paid is applicable.  More information can be found in the Fees Guidelines.

Information on national duplicate applications can be found here.

Q&A on end of procedure requirements:

1. What will be required by the Medicines Authority during the national phase at the end of a decentralised or a mutual recognition procedure?

As stated in the Notice to Applicants, EUDRALEX Volume 2A Chapter 2, the applicant should provide the requisite documentation (adequate translation of the agreed Summary of Product Characteristics, package leaflet and labelling) by not later than 5 calendar days after the end of the procedure.   Adherance to timelines is important to ensure timely grant of the marketing authorisation in line with the statutory timelines.

As both English and Maltese are official languages for Malta, the product information (PI) may be submitted in English and/or Maltese and the product may be placed on the market in either language.

The PI should be updated with the Malta specific details such as the product name, batch release site/s, ADR reporting details, MA number and MA holder.

If available, the mock-ups of the labelling and package leaflet (as they will be made available to the patient) should be submitted at the end of the procedure, or at the latest, before the product is placed on the market.

2. Where should the end of procedure documents be sent?

The end of procedure documents can be either sent through the CESP or to the mailbox mrp-dcp.adm@gov.mt.

Further information on document submission can be found in the following page on our website: http://www.medicinesauthority.gov.mt/requirementssubmission

Page updated on 29/4/2024