BioVentures Consulting Limited has experience in renewals the Marketing Authorization, which is initially valid for 5 years. We can assess the safety and efficacy data which is available since the original MA and help reassess the risk/benefit evaluation. BioVentures Consulting Limited can compile the renewal application on behalf of its clients, whether the MA was approved via the Centralized Procedure (CP) or via the Mutual Recognition Procedure (MRP) or Decentralized Procedure (DCP). We can provide assistance with guideline interpretation and dossier requirements for the renewal application (Note: the CP Regulation (EU) No. 1234/2010 applies from 2nd July 2010; and MRP/DCP Directive 2010/84/EU applies from 21st July 2012.
BioVentures Consulting Limited can oversee the renewal application and approval through the 90-Day timetabled process, ensuring that the submission deadline and timetabled procedures are followed. We can assess the content of the renewal and ensure that an evaluation of the data contained on the suspected adverse reaction reports and PSURs have been included, and the application is submitted at least 9-months before the expiry of the authorization (previous guidelines required 6-months). In cases of renewals via the CP, BioVentures Consulting Limited can initiate the pre-renewal submission dialogue with EMA (not relevant for MRP/DCP). BioVentures Consulting Limited can help address the list of outstanding questions (LoQs) where a positive opinion was not adopted by CHMP after 90 days, and facilitate the Oral explanation if a positive opinion has not been adopted by Day 120. In cases of renewals via the MRP/DCP BioVentures Consulting Limited can address any request for supplementary information (RSI) at the Day 59 procedural step on behalf of its clients.
BioVentures Consulting Limited can compile all aspects of the renewal application itself, including the administrative components of Module 1 (application form, cover letter, GMP Certificate, list of all post-authorisation submissions since authorisation, the list of follow-up measures and specific obligations and expert CVs), as well as the product information (SmPC, package leaflet and product label). We can also add value by compiling all technical components for the renewal, such as the Quality Overall Summary and Clinical Overview (with accompanying expert statements) for Module 2, and PSUR for Module 5.
We can also add value by compiling all technical components for the renewal, such as the Quality Overall Summary and Clinical Overview
We can also advise on specific national legislation particular for the EU, of which there are several (e.g. requirements for TSE certificates for Latvia and Bulgaria; or the need for either the original or legalised copy of the annexes to the application form and statements when Italy is the RMS; and so on).
BioVentures Consulting Limited can oversee the post-opinion linguistic review and manage the QRD-PIQ comments through the Day+25 timetabled linguistic process for the EU translations relating to the SmPC, product label and patient information leaflet.
BioVentures Consulting Limited can conduct a pre-submission assessment of the renewal dossier for clients prior to submission and provide feedback as to whether there are any particular safety issues which could alter the benefit/risk balance of the product; assess any post-marketing studies which are on-going or planned in case any new safety data is relevant for the benefit/risk assessment, or determine whether there is a class review of a serious safety issue which is either on-going or imminent.
BioVentures Consulting Limited can act as a sounding board to clients and address questions relating to the renewal process such as:
- What is the difference between IBD and EBD?
- When is the data base lock for the PSUR?
- Can the classification of the medicinal product be amended at the time of the renewal?
- Can other non-renewal specific changes be included in the renewal application?
Because of our experience with both the practical and technical aspects of the renewal application, BioVentures Consulting Limited can be an ideal partner for renewal applications on behalf of its clients.