2
Apr 19
Patient disease registries: potential use for regulatory purposes
Public consultation on the discussion paper published by the European Medicines Agency (EMA) regarding the crucial role of patient disease registries in monitoring the safety of medicines is open until June 30, 2019.
1
Apr 19
<!--:it-->Personal Data: new interpretative recommendations in Clinical Trials<!--:-->
On January 23, 2019, the European Data Protection Board (EDPB) published an opinion on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR) regarding the processing of clinical trial data.
9
Feb 19
<!--:it-->Italian government approves a draft legislative decree amending italian legislation on clinical trials<!--:-->
On February 14, 2019, the Italian Government approved a draft legislative decree, implementing Law no. 3/2018 which delegated the Government to take measures to reform the Italian legislation on clinical trials on medicinal products for human use, with the purpose, among other things, to prepare the Italian legal framework to the future application of the Clinical Trial Regulation (EU) 536/2014.
New safety features for most prescription medicines and some OTC medicines supplied in the EU
8
Feb 19
Using medicinal product trademarks in clinical trials prior to marketing authorization does not amount to genuine use, states advocate general szpunar
On January 9, 2019, Advocate General (AG) of the Court of Justice of the European Union (CJEU) Maciej Szpunar gave his opinion on case C-668/17 (“Opinion”), a trademark dispute that, while focusing on medicinal products, raised two other far-reaching issues concerning the scope and definition of the requirement of genuine use within the provisions of Article 58 of Regulation (EU) 2017/1001 of the European Parliament and of the Council of June 14, 2017 on the European Union trade mark (“EUTMR”).
7
Feb 19
New law to settle the long-lasting dispute on the pharmaceutical payback for 2013-2017
On February 11, 2019, Italian Law no. 12/2019 was published in the Official Gazette of Italy, converting into law, with amendments, Italian Law Decree no. 135 of December 14, 2018 (also called the Simplifications Decree) aimed at simplifying certain administrative responsibilities for both private and public entities.
