Medicine Regulations

• What is the MHRA?

  Medicines and Healthcare products Regulatory Agency (MHRA)* an executive agency of the Department of Health and Social Care* The MHRA is also enforcement authority for licensing matters in theUK.
• What is a medicinal product?

  • NOT medicines (HMR2012)
  • For preventing or treating disease in human beings
  • Restoring, correcting or modifying a physiological function by exertinga pharmacological, immunological or metabolic action
  • Making a medical diagnosis.
  • Human blood is expressly excluded
• What does the HMR say about marketing authorisations for human medicines?

  • A person may not sell or supply or offer to sell or supply a medicinalproduct unless that product has a UK marketing authorisation
  • Summary of Product Characteristics (SmPC)
• What to do in case of an off labelling prescribing?

  • Treating a patient who has a condition for which the product does nothave a marketing authorisation
  • A marketing authorisation can be given to treat one condition but not another condition for which it may nevertheless be effective.
• What does the HMR say about the revocation, variation or suspension?

  • Harmful or ineffective
  • Incorrect information
  • Breach of licence
  • Unfulfilled licence
  • Information not provided
  • No longer EU based
  • Non-compliance with Good Manufacturing Practice (GMP)
  • Unfulfilled licence (non-UK)
  • Public at risk
  • Apply for change
  • Poor manufacturing
• What is an orphan drug?

  *used to treat conditions that occur infrequently
• What is an example of an orphan drug?

  Ibuprofen is an orphan drug when used to treat the rare disease patent ductus arteriosus in neonates
• How does a patient qualify for orphan medicine?

  • for a disease that is life-threatening or chronically debilitating
  • not more than 5 in 10,000
  • no satisfactory method exists
• What is a benefit that orphan medicinal products will have?

  • Orphan medicinal products will benefit from up to 10 years of marketexclusivity from similar products
• What are generics?

  • Have the same composition as a Reference Medicinal Products(RMPs)
  • Has the same pharmaceutical form
  • Appropriate bioavailability studies (demonstrated bioequivalence)
  • Typically, cheaper than branded medicines
• What are branded generics?

  • Generics that have a brand name.
  • Encourage medical practitioners to prescribe branded generics whichhave a lower price than non-branded generics
• What is an abridged procedure/ what it entails?

  • Manufacturers will have incurred the considerable cost of years ofR&D
  • A competitor can rely on the data for the original product only afterthe passage of a data exclusivity period.
  • The data exclusivity period is eight years for products that have beenauthorised in the UK.
• What is the (EAMS) Early access to medicines scheme?

  • Enables patients to have access to medicines which have not yet beenauthorised
  • life-threatening or seriously debilitating conditions,
  • no suitable alternative
  • Voluntary
• What does pharmacovigilance entail?

  • Detection, assessment, understanding and prevention of adverseeffects or any other drug-related problem.
  • Promote the safe and effective use of drugs by providing reliableinformation
  • Information obtainable before a medicine is placed on the market isultimately limited
  • Both the licensing authority and holders of manufacturingauthorisations must operate a pharmacovigilance system
  • Capture and evaluate all information
  • Take all appropriate measures to minimise and prevent risk,
• What is the yellow card scheme?

  • MHRA
  • Collecting and monitoring information on suspected safety concernsor incidents involving medicines and medical devices.
  • Voluntary reporting
  • Early warning that the safety of a product may require furtherinvestigation.
• Why is the yellow card scheme not reliable?

  • The Cumberlege Review (2020) concluded that the Yellow Card scheme could not be relied upon to identify promptly significant adverse outcomes.