2024-01-11 10:44:02
Coronavirus and Influenza exemptions
The Health Secretary has laid draft Regulations before Parliament that would extend the temporary provisions in regulations 3A and 19 of the Human Medicines Regulations 2012 until 1 April 2026.
The temporary powers in the draft Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024 would permit professionally justified acts of preparation and assembly of coronavirus vaccine when carried out under the supervision of a doctor, nurse or pharmacist at any location, without the need for a manufacturer’s licence or marketing authorisation, on condition that these acts are done under NHS arrangements (or the medical services of HM Forces).
The amendments also allow unauthorised medicinal products to be used for the reformulation of coronavirus vaccines (for example, diluents) to be re-assembled for the purpose of supply.
The amendments additionally provide an exemption from the need for a wholesale dealer’s licence such as the sharing of coronavirus and influenza vaccinations between vaccination centres.
Regulation 247A of the Human Medicines Regulations exempts from the requirements of regulations 214 (supplying in accordance with a prescription) 220 (supervision) and 221 (general sale medicines to be supplied without repackaging from premises that can be closed to the public) the supply under a national protocol of a medicinal product used for vaccination or immunisation against coronavirus or influenza. Such supplies can be made at any time, not just during a pandemic or when a pandemic is imminent.
Medical Devices timeline
The MHRA has announced extended timelines for the acceptability of CE marking on medical devices. The timelines are now as follows:
- general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
- in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
- general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the 30 June 2030.
New legislation that deals, amongst other things, with post-market surveillance, is expected to be introduced later this year.