http://pclportal.mhra.gov.uk/ WebTo get a licence, the manufacturer of the medicine has to provide evidence that shows that the medicine works well enough and is safe enough to be used for a specific condition …

MHRA awards first ‘innovation passport’ under new pathway

WebManufacturer’s Specials Licence as issued under the terms of the Human Medicines Regulations 2012 are inspected for compliance with the principles of GMP by the Medicines and Healthcare products Regulatory Agency (MHRA). The minimum standards expected for such Radiopharmacies can be found in the MHRA Guidance for Specials Web18. dec 2014. · Marketing authorisations, variations and licensing guidance Collection Marketing authorisations: lists of granted licences Marketing authorisations (MAs) … ryan curylo

Medicines and Healthcare products Regulatory Agency

WebMHRA: Medicines and Healthcare Regulatory Authority. An executive agency of the UK Department of Health which is responsible for ensuring that medicines and medical … Web26. feb 2024. · MSD's (Merck Sharp & Dohme (UK) Limited) investigational drug belzutifan on Friday became the first drug to be awarded an “innovation passport” under the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) innovative licensing and access pathway (ILAP). Belzutifan is being developed to treat adults with von Hippel … Web06. jan 2024. · The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) awarded a total of 41 “innovation passports” for new drugs under development last year. The grant of a passport opens the door to the agency’s Innovative Licensing and Access Pathway (ILAP), which was introduced in January 2024. In a 30 December update, the … is dr nick still alive