Prescription proprietary medicinal products
Ordinance of the Federal Minister for Labour, Social Affairs, Health and Consumer Protection on ensuring the supply of medicines
The proposal is primarily composed of the following measures:
Introduction of an obligation for the marketing authorisation holder to immediately notify any restriction of the domestic distribution of a prescription proprietary medicinal product.
Publication of all notified proprietary medicinal products on the website of the Federal Office for Safety in Health Care.
Obligation of notification of the Federal Office for Healthcare Safety [Bundesamt für Sicherheit im Gesundheitswesen] if the marketing authorisation holder does not or does not sufficiently observe his notification obligation or if for other reasons the supply is not adequate to cover the needs of patients.
Introduction of a ban on exports to another Member State of the European Economic Area.