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 facility declaration form

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

  3. Blood establishment authorisation application form

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

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Guidance and regulation

  1. Zika virus: country specific risk
  2. NHS terms and conditions: procuring goods and services
  3. Managing common infections: guidance for primary care
  4. Supply unlicensed medicinal products (specials)
  5. Good manufacturing practice and good distribution practice
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News and communications

  1. All T34 ambulatory syringe pumps – update concerning battery information (MDA/2018/035)
  2. Hydrochlorothiazide: risk of non-melanoma skin cancer, particularly in long-term use
  3. Systemic and inhaled fluoroquinolones: small increased risk of aortic aneurysm and dissection; advice for prescribing in high-risk patients
  4. Sildenafil (Revatio and Viagra): reports of persistent pulmonary hypertension of the newborn (PPHN) following in-utero exposure in a clinical trial on intrauterine growth restriction
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Research and statistics

  1. Mefloquine (Lariam) prescribing in the UK armed forces: 12 September 2016 to 30 September 2018
  2. European Antibiotic Awareness Day: evaluations
  3. Medicines: licensing time-based performance measures
  4. Family Practitioner Services Statistics for Northern Ireland 2017/18
  5. Early access to medicines scheme applications: pending, refused, granted
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Policy papers and consultations

  1. Statutory scheme to control costs of branded health service medicines
  2. Health institution exemption for IVDR/MDR
  3. Reclassification of Otrivine extra dual relief nasal spray solution (ARM 90)
  4. Innovation: Queen’s University Belfast
  5. Innovation: MHRA advises the Cell Therapy Catapult of regulatory requirements
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Transparency and freedom of information releases

  1. PPRS aggregate net sales and payment information: August 2018
  2. Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2018 - 2019
  3. Clinical trials for medicines: authorisation assessment performance
  4. Medicines and Healthcare products Regulatory Agency spending over £25,000: 2018 to 2019
  5. Medicines and Healthcare products Regulatory Agency spending over £25,000: 2017 to 2018
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