CRED Managing Variations Effectively

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. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation /q_and_a/q_and_a_detail_000019.jsp&mid=WC0b01ac0580023b 12 ) – 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 ) ● Ultimately you want to seek to avoid delays in approval caused by administrative errors