DHSC) and other healthcare partners and stakeholders to rapidly identify where flexibilities in the regulation of medicines and medical devices may be possible.
This is with a view to supporting the healthcare products supply chain and wider response to the coronavirus (COVID-19) outbreak in the UK.Please bear in mind that flexibilities do not displace or diminish any other obligations applicable to the relevant products.
Any medicinal product which benefits from these regulatory flexibilities remains subject to marketing authorisation.Requirements set out for each of the regulatory flexibilities may vary (for example, pre-conditions and notifications).
Manufacturers should take great care to meet the relevant requirements and must satisfy themselves that the product remains safe to use before putting a flexibility in place.None of these flexibilities amount to authorisation or a recommendation by the MHRA for the purposes of Regulations 174 and 345 of the Human Medicines Regulations.These regulatory flexibilities are:We have identified areas of flexibility which differ from the EU.