![]() ![]() It is not intended to provide practical advice on how to use this product. It explains how this product was assessed and how its authorisation was recommended, as well as its conditions of use. The Public Assessment Report ( PAR) is a scientific report, written by the MHRA. This is based on the Summary of Product Characteristics of the product. The Patient Information Leaflet provides information for patients on using the medicine safely. Patient Information Leaflet ( CMA)/Information for UK Recipients (R174) It is used by healthcare professionals, such as doctors, nurses and pharmacists. It explains how to use and prescribe a medicine. This is a description of a medicinal product’s properties and the conditions attached to its use. Summary of Product Characteristics ( CMA)/Information for Healthcare Professionals (R174) The MHRA regularly publishes reports of the safety of the COVID-19 vaccines.įor further information on prioritising the first COVID-19 vaccine dose see the statement from the Joint Committee on Vaccination and Immunisation (JCVI). The COVID-19 Vaccine AstraZeneca authorised under Regulation 174 remains in use and its product information has been updated in line with the product information of the GB CMA. ![]() Please regularly check this information as it is often updated. The information for healthcare professionals and UK recipients on using the vaccine safely has been periodically updated as new data have become available and this will continue under the CMA. Manufacture of the vaccine remains unchanged, as do the clinical, pharmacological and pharmaceutical properties of the vaccine. To date, supply of the AstraZeneca vaccine in the UK has been authorised on a temporary basis by the MHRA under Regulation 174 of the Human Medicine Regulations 2012, but as this was always intended to be a temporary arrangement, supply of this vaccine will change to be in accordance with the CMAs. A CMA issued by the European Medicines Agency has had effect in Northern Ireland since 29 January 2021. On 24 June 2021, the MHRA issued a Conditional Marketing Authorisation ( CMA) for COVID-19 Vaccine AstraZeneca in Great Britain (GB). ![]()
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