OpenLegislation

Part 6 MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS

United Kingdom

  1. 36Requirement for authorisation to manufacture or import investigational medicinal products
  2. 36AManufacture of MM investigational medicinal products
  3. 36BManufacture of POC investigational medicinal products
  4. 37Exemption for hospitals and health centres
  5. 37AExemption for radiopharmaceuticals used for diagnostic purposes
  6. 38Application for manufacturing authorisation
  7. 39Consideration of application for manufacturing authorisation
  8. 40Grant or refusal of manufacturing authorisation
  9. 41Application and effect of manufacturing authorisation
  10. 42Obligations of manufacturing authorisation holder
  11. 43Qualified persons
  12. 43AApproved country for import
  13. 44Variation of manufacturing authorisation
  14. 44AVariation of MM (IMP) master file
  15. 44BVariation of POC (IMP) master file
  16. 45Suspension and revocation of manufacturing authorisation