The new obligation to supply medicines at the request of Member States: analysis of Article56a of the Medicines Directive

Article56a of the European Union’s new Medicines Directive introduces a mechanism that allows Member States to require marketing authorisation holders to supply authorised medicines within their territory to meet the needs of their patients. In the event of non-compliance three years after the request, the holder may lose market protection in that Member State, thereby allowing the entry of generic and biosimilar medicines. However, exceptions are provided for in cases of exceptional and unforeseeable circumstances beyond the holder’s control, as well as safeguards to prevent the loss of protection in one Member State from being used to circumvent the system in other protected markets.

Download document

View document