Part 6 MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL PRODUCTS
United Kingdom
- 36Requirement for authorisation to manufacture or import investigational medicinal products
- 36AManufacture of MM investigational medicinal products
- 36BManufacture of POC investigational medicinal products
- 37Exemption for hospitals and health centres
- 37AExemption for radiopharmaceuticals used for diagnostic purposes
- 38Application for manufacturing authorisation
- 39Consideration of application for manufacturing authorisation
- 40Grant or refusal of manufacturing authorisation
- 41Application and effect of manufacturing authorisation
- 42Obligations of manufacturing authorisation holder
- 43Qualified persons
- 43AApproved country for import
- 44Variation of manufacturing authorisation
- 44AVariation of MM (IMP) master file
- 44BVariation of POC (IMP) master file
- 45Suspension and revocation of manufacturing authorisation