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12 results found

Article

Bird & Bird LLP | European Union, Germany | 18 May 2014

The Bolar exemption protection of API suppliers

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

Article

Bird & Bird LLP | European Union | 21 Oct 2010

Policy on use patents for the registration of generic medicinal products

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.

Article

Bird & Bird LLP | France | 15 Dec 2009

Comparative advertising of a generic medicine

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.

Article

Bird & Bird LLP | Sweden | 11 Mar 2009

Substitutable medicinal products

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).

Article

Bird & Bird LLP | Italy | 11 Mar 2009

Access to registration dossier data of generic companies

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).

Article

Bird & Bird LLP | France | 29 May 2007

Implementation of Directive 200427EC on the Community Code relating to medicinal products for human use into French 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.

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