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Tag Archives: summary of product characteristics

European Commission publishes recommendations concerning the summary of product characteristics and patient information leaflet for medicinal products

  The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the Patient Information Leaflet (PIL) of medicinal products for human use. The report identifies shortcomings concerning the SmPC and the PIL, and provides recommendations on the way in which SmPC and PIL could be improved.

France imposes an extra notification obligation on Class III and implantable medical devices manufacturers

On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“French Law 2016-41”) was adopted. This Decree provides important information concerning the obligation for manufacturers of implantable medical devices and manufacturers of Class III medical devices to submit a summary of product characteristics to the French Agency

EMA Updates Product Information Templates for Medicinal Products for Human Use

On 10 June 2015, the European Medicines Agency published the revised Human Product Information templates for medicinal products in the European Union (“EU”). The revised Quality Review of Documents (“QRD”) template concerning centralised procedures is most notably affected by this update. The update introduces certain modifications to the Human Product Information template and is intended

EMA OPENS CONSULTATION ON GUIDELINES FOR CORE SMPC FOR HUMAN PLASMA DERIVED PRODUCTS

On 1 October 2014 the European Medicines Agency (“EMA”) opened a consultation on revisions to its guideline on core summary of product characteristics (“SmPC”) for human plasma derived and recombinant coagulation factor IX products (the “Guidelines”).

The Guidelines are intended to provide harmonised guidance to applicants and regulators regarding the information that is to be included in the SmPC for human plasma derived and recombinant coagulation factor IX products, which are indicated for use in the treatment of prophylaxis of bleeding in patients with haemophilia B.

European Commission adopts the black symbol to be placed in the patient information leaflets for medicinal products subject to additional monitoring in the EU

On 7 March 2013, the European Commission adopted a black triangle as the symbol to be placed on the patient information leaflets and the Summary of Product Characteristics (“SmPC”) of medicinal products “subject to additional monitoring” in the European Union (“EU”). The history of the black triangle The requirement to include a black symbol in