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.
6
Feb 19
No deal brexit’s impact on the pharmaceutical and medical devices industries: guidance from the ema and the european commission
On January 15, 2019, the UK House of Commons rejected the withdrawal agreement reached by Theresa May and the EU after a long and exhausting negotiation period of almost 2 years.
5
Feb 19
Benefit companies: an overview from a corporate perspective
Italy was the first European country to issue a regulation on benefit companies (in Italian “società benefit”), importing the model from the US.
EMA has launched a public consultation on key principles for the electronic product information of EU medicines
4
Feb 19
The European Commission issues a recommendation on a European electronic health record exchange format
On February 6, 2019, the European Commission issued a Recommendation concerning the development of a European Electronic Health Record (EHR) exchange format (Recommendation no 243/2019), which can be found on the following website: https://bit.ly/2X2qhAq.
1
Feb 19
The European Parliament legal affairs committee votes in favor of a comprehensive SPC manufacturing waiver
In May 2016, the European Parliament, in its Resolution on the Single Market Strategy, endorsed the need for changes to the EU supplementary protection certificate (“SPC”) and urged the Commission to introduce and implement an SPC manufacturing waiver before 2019, without undermining the market exclusivity granted under the SPC in the protected markets.
