Freedom of Information request on Public Assessment Reports (PARs) for paracetamol-only products (FOI 21/469)
Published 28 June 2021
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27th May 2021 FOI 21/469 Dear
Thank you for your email.
Public Assessment Reports (PARs) are prepared for all new marketing authorisations (MAs) granted after 31 October 2005. These PARs are available on the MHRA website for all MAs granted via national and European procedures where the UK was Reference Member State (RMS), on the European Medicines Agency website for all MAs granted via Centralised procedures, and on other member state websites for MAs granted via European procedures where the UK is a Concerned Member State (CMS).
MHRA does not have an accurate list of all paracetamol-only products granted via well-established use (Article 10a), as some MAs for paracetamol are older and so pre-date when we would have recorded the legal basis for the application on our systems.
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU