Medicines, medical devices and blood regulation and safety

Services

  1. Sunset clause: request for public health exemption

    Apply for a public health exemption from the sunset clause.

  2. Blood establishment authorisation application form

    Form to apply for a blood establishment authorisation and guidance on completing the form.

  3. Blood facility declaration form

    Blood facility declaration form to be completed and returned to MHRA.

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Guidance and regulation

  1. Zika virus: country specific risk
  2. Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal
  3. How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal
  4. Good manufacturing practice and good distribution practice
  5. Managing common infections: guidance for primary care
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News and communications

  1. Human and veterinary medicines: register of licensed wholesale distribution sites
  2. Datex-Ohmeda Aisys CS2 and Aisys anaesthesia devices with software version 11 and version 11 SP01 (Service Pack) – Risk of ventilation loss, inadequate anaesthesia and hypoxia or severe hypotension (MDA/2019/001)
  3. Human and veterinary medicines: register of licensed manufacturing sites
  4. Parallel import licenses granted in December 2018
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Research and statistics

  1. Early access to medicines scheme applications: pending, refused, granted
  2. Medicines: licensing time-based performance measures
  3. Quarterly reports on the import of unlicensed medicines
  4. Family Practitioner Services Statistics for Northern Ireland 2017/18
  5. Family Practitioner Services Statistics for Northern Ireland Quarter 1 and Quarter 2 2018/19
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Policy papers and consultations

  1. Implementing ‘safety features’ under the Falsified Medicines Directive
  2. Statutory scheme to control costs of branded health service medicines
  3. Getting medication
  4. Voluntary scheme for branded medicines pricing and access
  5. Voluntary scheme for branded medicines pricing and access: heads of agreement
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Transparency and freedom of information releases

  1. Clinical trials for medicines: authorisation assessment performance
  2. PPRS aggregate net sales and payment information: November 2018
  3. MHRA gender pay gap report
  4. PPRS aggregate net sales and payment information: August 2018
  5. Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2018 - 2019
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