Spring Intro 2023

Submission strategy = Understanding the change(s)

Compliance

• CP • MRP/DCP • N

Consider proposed change(s)

Consider justification required

Type of MA?

Science

• IA • IB • II • EA

Prepare supporting information

Check the Guidance documents

Type of change?

IA:

prior to notification Implementation

Send to the correct Regulatory Authority

Fill in relevant part of guideline (IA/IB/II)

parts of form Fill in relevant

Pay the fee

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Differences in Processing Variations

● All variation procedures share a fairly common process (submission, validation, (questions), approvals) but there are differences – Centralised Licences (See EMA Website – e.g. New variations regulation: Regulatory and procedural guidance | European Medicines Agency (europa.eu)) – MRP/DCP Licences (CMDh - http://www.hma.eu/96.html ) – National Licences – refer to local legislation/guidance and national agencies websites (e.g. MHRA - https://www.gov.uk/guidance/medicines-apply-for-a-variation-to-your marketing-authorisation) ● Grouping and/or Worksharing can be used to align approval timelines and the reduce number of submissions

The Organisation for Professionals in Regulatory Affairs

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