The CJEU has recently been asked by the German courts to consider whether the Bolar exemption extends to a third party manufacturer which supplies a
Marketing authorisation holders of generic medicinal products sometimes remove information from the summary of product characteristics (SmPC) and the patient information leaflet to prevent the potential infringement of a use patent.
It is not necessary within the meaning of Article L. 713-6 of the French Intellectual Property Code (“CPI”) to mention the brand of the reference product in comparative advertising for a generic medicine, as the healthcare professionals to which the advertising is directed have other means (namely, the INN - international non-proprietary name) by which to identify the corresponding reference product.
Under the Swedish medicinal products benefits scheme, the pharmacist shall substitute any prescribed product for a cheaper generic or parallel imported product, provided such product has first been declared substitutable by the Swedish Medicinal Products Agency (MPA).
The right for access to administrative documents is regulated in Italy by law n. 2411990 and its relevant implementing rules (d.p.r. 1842003, hereinafter, the Law).
Directive 200427 dated 31 March 2004 amending Directive 200183 on the Community Code relating to medicinal products had to be implemented into French national law by 30 October 2005.