With certain exceptions, manufacturers of human and veterinary medicines are required to hold a Manufacturer’s Authorisation.
To obtain an authorisation to manufacture medicinal product compliance with the principles of Good Manufacturing Practice (GMP) must be demonstrated. Good Manufacturing Practice (GMP) is defined as “that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use”.
To verify that products are manufactured consistently to the required quality inspectors monitor compliance with the GMP principles through regular on-site inspections.
Third country manufacturers, i.e. those located outside of the European Economic Area (EEA), are also required to meet the equivalent standard of GMP as EEA manufacturers.