How will SecurMed UK count the number of Marketing Authorisation Holdings?
- EMA Centralised Procedure (CP) MA Holdings: – Applicable to all member states – Each named business entity CP MA holding counts as 1 MAH
- MHRA MA Holding (Manufacturer Licenses) – UK Local, EMA Mutual Recognition or EMA De-Centralised Procedure (DCP) – Each medicine authorised is assigned a UK product license number in the format: PL nnnnn/mmmm – The first 5 digits identify the MAH for that named business entity – For each named business entity and associated PLs the MAH number counts as 1 MAH
- MHRA PLPI (Parallel Importer License) – Follows same format for MHRA MA holding and will be counted the same way. – For each named business entity 1 PLPI MAH number counts as 1 MAH – Where a manufacturer/ PI holding both an MAH and PLPI with the same MA holding number this is counted as 1 MAH
- EMA Parallel Import Notification Letters – EMA does not issue Parallel Import MAHs but SecurMed is aware EMA issues Parallel Import Notification letters in some countries. – These are expected to be few and will be dealt with as they arise, if at all, in the UK. – Assumption is that 1 Parallel Import Notification Letter will count as 1 MAH.”