Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Decentralised (DCP) and Mutual Recognition Procedures (MRP)

BioVentures Consulting Limited can provide advise on the different European regulatory procedures available, and interpret the current legislation regarding the Mutual Recognition Procedure (MRP) and Decentralized Procedure (DCP). We can provide guidance on the advantages and disadvantages of MRP vs DCP, including timelines and data requirements. After 30th October 2005 the DCP became a possible registration procedure in the EU, alongside other options of the Centralized, MRP and national procedures. BioVentures Consulting Limited can manage the timelines and process for all EU procedures. For the MRP we can manage the submission to the Reference Member State (RMS), interact with the agency regarding necessary clock-stops, provide dossier updates in line with changes made during RMS approval and submission of the updated dossier, the licence and Assessment Report in Concerned Member States (CMS) leading up to the start of the bilateral phase of the MRP. BioVentures Consulting Limited can manage the activities throughout the remaining 90 day process and work with clients to draft answers to the RMS and negotiate SmPC wording with CMS. We understand the criticality of Days 50-75 and Days 75-90 in the process, and that success is very dependent on the level of harmonisation of the SmPC.

The decision to register via the MRP or DCP route is a complex one, which ideally requires cross-functional input

BioVentures Consulting Limited can also manage the DCP for its clients

We can oversee the submission to both the RMS and the CMS, including the Day 70 preliminary Assessment Report, SmPC, PIL and labelling aspects, and work with clients to address any clock-stop questions at Day 105, negotiate with the RMS on the date of submission of the final response; or else respond to the Day 120 assessment report and the continuing the 30 day national step. In cases where the 30 Day RMS/CMS approval is not granted, and the CMS(s) raise objections we can provide support during the 60 day referral procedure, helping to resolve issues to lead to approval.

In addition to managing the DCP or MRP processes and procedures BioVentures Consulting Limited can provide strategic advise on the most appropriate registration route for our client’s products. We will take into account the opportunities to negotiate with Agencies, the speed of review and approval times, the relevance of the sunset clause if applying for more than one MA and the differing opportunities afforded for building a robust dossier during review. BioVentures Consulting Limited can advise on the choice of RMS and the factors to consider when making this choice, the time required to develop the product, the application for timeslots, and consider the needs of stakeholder groups such as marketing and business development licensing teams. The decision to register via the MRP or DCP route is a complex one, which ideally requires cross-functional input. In this regard BioVentures Consulting Limited can provide some valuable insights, advise and management expertise to our client’s regulatory affairs teams.

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