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Expected time taken to process and grant a marketing authorisation or a variation to a marketing authorisation.
A policy review of the CTDA process, established in July 2021, which governs the validation of antigen and molecular coronavirus (COVID-19) detection tests.
The Medicines and Healthcare products Regulatory Agency (MHRA) assesses its regulatory impact on businesses.
This PAR covers the assessment of the application to increase the pack size of Neutrogena T/Gel Therapeutic Shampoo to a maximum of 500ml as a GSL medicine.
This Public Assessment Report (PAR) covers the assessment of the proposal to add three new pack sizes (3, 4 & 6 cannisters) to the licence for Nicorette QuickMist 1mg/spray mouthspray and Nicorette QuickMist Smart Track …
This PAR covers the assessment of the proposal to make Sudafed Plus Blocked Nose 1mg/50mg/ml nasal spray solution, containing xylometazoline hydrochloride 1mg/ml (0.1% w/v) and dexpanthenol 50mg/ml (5% w/v), available throug…
Public Assessment Report on our review of epidemiological data for cardiovascular safety.
This PAR covers the assessment of the proposal to make Buscopan IBS Relief, Hyoscine Butylbromide 10mg tablets available through general retail outlets.
Public Assessment Report of our review of the use of chloramphenicol eye drops containing borax and boric acid buffers in children under 2 years.
Public Assessment Report on our review of the risks of using haloperidol for the acute treatment of delirium in elderly patients.
This report provides a combined summary of the conclusions and recommendations of the Commission on Human Medicines’ Adrenaline Auto-injector Expert Working Group to support the effective and safe use of Adrenaline Auto-inje…
This PAR covers the assessment of an application to reclassify Calci-D chewable tablets from Prescription Only Medicine (POM) to Pharmacy (P) medicine.
Public Assessment Report (PAR) reviewing available safety data for topical steroid withdrawal reactions, which have been associated with topical corticosteroids.
The Commission on Human Medicines (CHM) has reviewed the available safety data for the use of the macrolide antibiotics erythromycin, clarithromycin and azithromycin during pregnancy.
This PAR covers the assessment of an application to reclassify Nasacort Allergy Relief for Adults 55 micrograms/dose, nasal spray, suspension from Pharmacy (P) medicine to General Sales List.
This PAR covers the assessment of an application to reclassify Almerg 180mg film-coated tablets from Prescription Only Medicine (POM) to Pharmacy (P) medicine.
The Commission on Human Medicines (CHM) has concluded that the risk of vCJD cases arising from the use of UK plasma for the manufacture of immunoglobulin medicinal products would be negligible.
A regulatory approach for updating authorised coronavirus vaccines should mutations at any time make them less efficacious due to insufficient cross-reactivity.
The MHRA has developed, and now has in place, a four-stranded approach to vigilance, which is summarised in this report.
The Commission on Human Medicines has reviewed the available safety data for epilepsy medicines during pregnancy.
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