Legal presence requirements in UK
The transition period was not extended at five minutes to midnight on 30 June 2020. In theory the UK and EU may negotiate an agreement which means that all the previously published MHRA requirements listed for a “no deal” Brexit may not be needed at the end of the transition period – 31 Dec 2020. This ‘no deal’ guidance was withdrawn by the government earlier in 2020. The outcome of the current negotiations are uncertain but in the absence of an agreement being concluded, the requirements concerning legal presence need to be considered.
Strategically, reducing risk would be to take action before the deadline occurs. There will be certain requirements around legal presence in the UK for Marketing Authorisation Holders (MAH). The requirements previously published indicate that:
- A MAH should be established in the UK within 2 years, based on previous guidance issued in Oct 2019. Nothing has been published to support this position yet, but forms our best guesstimate.
- A Qualified Person for Pharmacovigilance (QPPV) should be established in the UK on day one. However, a temporary exemption will allow companies 21 months after 31 Dec 2020, to keep their EU QPPV as the UK QPPV. This temporary exemption will allow an EU QPPV to assume responsibility for UK MAs until a QPPV who resides and operates in the UK can be established. See Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit.
- In respect of a manufacturing licence, a Qualified Person (QP) for products manufactured in the UK or directly imported into the UK from a country not on an approved country list (which will include all EU and EEA countries from Day 1 must reside and operate in the UK.
- For products imported from an approved country list (EU and EEA countries), see section on licensing regime for wholesalers importing QP certified medicines below. See Importing medicines from the EEA after Brexit.
Where the MAH is not established in the UK on exit day, companies will be expected to put in place a UK-based contact person within 4 weeks of Brexit. This individual must be accessible to the licensing authority in respect of any matter relating to the MA. This requirement will no longer apply once a UK MAH is established.
At Jenson R+ we can help our non UK clients by providing Market Authorisation Holding services, UK QPPV services and a contact point to meet the MHRA requirements within 4 weeks of Brexit.
For UK companies with European licences we can provide the same MA holding service through our Dublin office and also EU QPPV and EU QP services as required. Indeed the guidance for an EU MAA does not have any transition or temporary measures in place. Here all EU MAAs must comply with EU requirements for MAH, QPPV, batch release on 01 Jan 2021. We recently published our view of the Brexit timeline which may prove a useful reference and how we can help. http://jensonr.com/timeline-for-eu-batch-release-and-mah-activities/
Please contact us at email@example.com