Type II variations
Type II variations are those which have a more significant impact on the quality, safety or efficacy of a medicinal product and which require assessment by regulatory agencies. BioVentures Consulting Limited can compile and submit Type II variations on behalf of its clients. Examples include:
- a new or changed indication changes to the SmPC resulting from new quality, safety, efficacy or pharmacovigilance data (for example as a result of changes to the manufacture, formulation or impurities)
- changes to the specification limits if these fall outside the already approved limits or manufacturing site changes.
BioVentures Consulting Limited can provide assistance in determining the type of variation required to its clients marketing authorisations, and interpret the classification guideline. We can offer clients procedural assistance throughout the 60-90 day evaluation process, and advice regarding the implementation of the changes and the timelines involved, including the timelines and process for responses to Agency Requests for Supplementary Information (RSI).
We can add particular value in cases where responses to RSIs involve robust technical data assessment and strong scientific understanding
BioVentures Consulting Limited can provide guidance regarding Type II variations submitted via the Centralised Procedure (which can be implemented once the EU Commission has amended the decision granting the marketing authorisation and notified the MAH) as well as those Type II variations submitted via the MRP (where implementation of the change is 30 days after the MAH has been informed about the acceptance by the RMS, without the need to wait for national updates of the marketing authorisation.
Type II variations are an important part of product life-cycle management and one in which BioVentures Consulting Limited can provide valuable assistance to clients. We can add particular value in cases where responses to RSIs involve robust technical data assessment and strong scientific understanding to explain the strategy or defend statements made in the dossier.