Medicines: variation forms for a manufacturer's licence
Forms to make a variation to a manufacturer's licence.
Medicines: application forms for a manufacturer licence
To apply for a manufacturer licence, complete the appropriate form. Applications for a manufacturer licence will be payable on invoice.
Sunset clause: request for public health exemption
Apply for a public health exemption from the sunset clause.
Notification of intent to import an unlicensed medicinal product
Notification form to confirm the import is requested by a doctor or dentist and is for use by his patients on his direct responsibility.
Application form for a traditional herbal registration (THR)
Apply for a traditional herbal registration (THR) to market a traditional herbal medicine (remedy) in the UK.
Guidance and regulation
- Confidentiality: NHS Code of Practice
- Decontamination in primary care dental practices (HTM 01-05)
- Clinical trials for medicines: manage your authorisation, report safety issues
- Health and Social Care Act 2008: code of practice on the prevention and control of infections
- Good manufacturing practice and good distribution practice
News and communications
Research and statistics
- Independent Breast Screening Review report
- Medicines: licensing time-based performance measures
- Pharmacovigilance inspection metrics, 2009 to present
- Seasonal flu vaccine uptake in healthcare workers: monthly data, 2018 to 2019
- Syringe drivers: review of actions around the 2010 safety alert
Policy papers and consultations
- Appropriate clinical negligence cover
- Government response to Health Service Safety Investigations Bill report
- Gosport Independent Panel report: government response
- Kark Review: terms of reference
- Health Service Safety Investigations Bill
Transparency and freedom of information releases
- Clinical trials for medicines: authorisation assessment performance
- Annual reports of the ABRHP and the HMAC
- MHRA Corporate Plan 2013 to 2018
- Parallel import licences granted in June 2014
- Medicines and Healthcare Products Regulatory Agency Business Plan 2014 to 15