https://medregs.blog.gov.uk/2018/04/26/variations-masterclass-workshop/

Variations masterclass & workshop

March 19th saw the third variations masterclass & workshop (a repeated, single day event) conclude with an overall attendance of 143 delegates from 104 companies.  Presentations were held in the morning covering the submission of variation procedures involving Patient Information Quality Unit (PIQU), Groupings, Worksharing and Composite Coordinated Collections (CCC) submissions.  Two workshops were held in the afternoon which focussed on both quality and clinical aspects and covered a range of scenarios and case studies, which provided learning opportunities on:

  • developing submission strategies using grouping, worksharing, CCC scheme, etc
  • critically evaluating situations which may have an impact on approval
  • identifying the required documentation to submit in support of a specific change
  • selecting the correct approach to update a MA in line with Company Core Data Sheet (CCDS)
  • identifying the category of variation for the submission of a range of changes (change code, type and timetable)
  • selecting the correct fees payable in the UK for different variation submission types

More than 88 questions were raised during the three events in respect to variations, CCC procedures and groupings and were discussed during the feedback sessions. Some examples of responses to questions received include:

  • the implementation date for a Type IA change does not need to be stated when the Type IA is submitted as part of grouped Type IB or Type II variations. The implementation date for the Type IA change will be the date of approval of the grouped variation
  • the extent of revision of module 3 sections expected to be updated during an updated CEP submission depends on the type of change introduced as part of the CEP update; for example, if a new solvent is used in the manufacturing process of the active substance and consequently additional tests and controls are included in the specification applied by the active substance manufacturer these changes are required to be included in the specification applied by the finished product manufacturer upon receipt of the material
  • an update of the SmPC in line with the CCDS is expected to be supported by data and scientific evidence, which will be regarded as new information. Consequently, the clinical overview should be updated to include study reports, literature etc. presented in support of the CCDS update
  • in order to comply with the Falsified Medicines Directive (FMD) requirements, label mockups updated with barcode and associated information may be registered via an Article 61.3 notification (self-certification) as these changes have minimal impact on the design and layout of the carton
  • minor changes to the PIL (e.g. QRD updates) may be combined with changes that are being registered via any of the full PIQ assessment categories (P1 - P4)

These and other questions received throughout the events have contributed towards current and future articles for the MedRegs blog. Blogs being prepared include Administrative changes, Complex fees, submitting a variation that impacts the SPC, label and patient information leaflet. They have also formed part of a comprehensive update to the LD variations webpage.  Updates to the LD website include more in-depth summaries of Type IA, IB and TII procedures, CCC submissions, newly published details of default procedures, Notification With Grounds (NWG) responses, and Type II timeframes and timetables. Sign up to get alerts when we post future blogs.

If you have any questions regarding the above points, please contact the Regulatory Information Service (RIS) at variationqueries@mhra.gov.uk