- UK & EU Regulatory Affairs
- UK based QPPV and EU based QPPV
- MIA for Importation into UK
- Medical Device UK RP
- Cosmetic UK RP
- GDP RPi
The UK left the European Union on 31st January 2020.
Until 31st December 2020 there is a transition period, which in practice means that the pharmaceutical (medicinal products and medical devices) and cosmetic industries continue to comply with current EU regulations and guidance.
Negotiations between the EU and the UK are presently underway but the requirements after 31st December 2020 are still unknown, and therefore we must prepare for a scenario with no mutual recognition or concessions to residency until (if) other arrangements are confirmed.
QP-Services UK Ltd have a good understanding of regulatory affairs across the EU and particularly within the UK, and we have been following developments closely since the Brexit vote in 2016.
We have partnered with an EU QPPV so that we can continue to provide a UK and EU based pharmacovigilance service, if required in 2021.
If/when required, we will be providing a named UK Responsible Person (RP) service for Medical Devices and Cosmetics.
We already hold a Manufacturer’s/Importer’s Authorisation (MIA 29498) which can be used to import and batch certificate products from outside of the EU. It is anticipated that this licence will also permit importation into the UK from the EU, if required. We already have established ways of working that meet all GMP and GDP requirements for QP batch release following importation. We have two Qualified Persons (WPs) named on MIA29498.
In 2019 the MHRA indicated that an MIA may not be the only route for importation from the EU. Companies holding a Wholesale Dealers Authorisation (WDA) may be permitted to name a Responsible Person for Importation (RPi) and import product accordingly. QP-Services UK Ltd has two Gold Standard RPs that would be eligible to act as RPi.
We will continue to monitor developments closely.
Contact us to discuss your requirements.