There is few time left until end of March and there are still quite some uncertainties with regards to the Brexit.
However, it is clear that the Marketing Authorization Holder (MAH), EU QPPV, PSMF and SME holder needs to be located within the European Union.
At the Medicines for Europe Conference, EMA provided an update on the status of the readiness of Brexit for the Centralised Procedure (CP).
It seems that Industry still needs some activities to get prepared, as out of 728 CPs, only 199 (27%) have completed all necessary changes.
In further details:
• Small and medium-sized enterprises (SMEs):
Only 13% of the SMEs that are registered with an UK office have done their changes. This implies that 214 companies still need to change their SME registration from UK to an EU country.
• EU Qualified Person for Pharmacovigilance (EU QPPV)
387 out of 444 (87%) still need to change their EU QPPV to a country with the EU.
For the MRP/DCP, the percentage looks better, but work is still pending: 621 procedures still need to change their UK RMS to another EU country. This represents a 26% of the total procedures.
Germany and Ireland have taken the majority of the RMS responsibility: 883 out of 2384 (37%) have been re-assigned to these two countries.
On 1st February, the CMDh released an update on the Q&A document.
If you have any question or in case you are not yet ready, please contact us at [email protected].
Asphalion can assist with the RMS transfer and provide EU QPPV, PSMF establishment and SME registration within the EU.