BREXIT – current challenges for Marketing Authorisation Holders

In the following cases Marketing Authorisation Holders/Holders of a Registration need to act, these tasks have to be finalised until 31.12.2020:

• If your medicinal product was authorised/registered within MRP/DCP with UK as RMS, a transfer to a new RMS needs to be performed (RMS switch) – currently this holds for one human and three veterinary medicinal products. Further information can be found at https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/austria-as-rms/rms-transfer.
• If the address of the Marketing Authorisation Holder/Holder of a Registration is established within UK, marketing authorisation/registration needs to be transferred to a site within EU/EEA  – currently this holds for ten human and one veterinarymedicinal products. Further informationen can be found at https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/change-of-ownership-acc-to-art-25-amg.
• If your batch release site is located within UK, this needs to be changed via variation to a state within EU/EEA – currently this holds for 49 human and 17 veterinary medicinal products. For further information regarding batch control and import please consult FAQs of CMDh/CMDv below.
• Also if QPPV resides and/or PSMF are located in UK, these need to be transferred. In case of human medicinal products, MAHs have to update Article 57 database directly.

Further information and FAQs regarding BREXIT are available on the following websites:

https://www.basg.gv.at/en/market-surveillance/official-announcements/detail/brexit

FAQs CMDh: http://www.hma.eu/535.html

FAQs CMDv: http://www.hma.eu/542.html

Further inquiry note

lcm@basg.gv.at