Information for Healthcare Professionals and UK recipients under Regulation 174 of the Human Medicines Regulations
This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. It does not have a marketing authorisation, but this temporary authorisation grants permission for the medicine to be used for active immunization to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over. As with any new medicine in the UK, this product will be closely monitored to allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
The Regulation 174 Information for UK COVID-19 Pfizer/BioNTech Vaccine Recipients can be found under the PIL tab and the Regulation 174 Information for Healthcare Professionals can be found under the SmPC tab.