2017/0337/NL
EC/EFTA
NL Niederlande
  • C00P - PHARMAZEUTIKA, KOSMETIKA
2017-10-20
2017-07-26
Medicines

Order of the Minister for Public Health, Welfare and Sport amending the Order on the Medicines Act in connection with reduction of the regulatory burden in the delivery of medicinal products for which a marketing authorisation has not been granted due to a special need of an individual patient

The amendment to the Order on the Medicines Act pertains to the manner in which the Health Care Inspectorate [IGZ] may grant approval for delivery of a medicinal product for which a marketing authorisation has not been granted, due to a ‘special need’ of an individual patient in the event of a medicine shortage. This Order removes the requirement, in such situations, for the prescribing physician to request approval from the IGZ for each patient, so the IGZ can grant approval at indication level. This will reduce the administrative burden on physicians, pharmacists and the IGZ. The option for the IGZ to grant generic approvals does not affect the requirement that the prescribing physician write out a prescription for each patient.