Portolano Cavallo

Life Sciences

Blog

Portolano Cavallo Life Sciences Blog  / European Commission
20 Jun
European Commission proposals for new regulation of compulsory licensing
On April 27, 2023, the European Commission published proposals for a new set of regulations aimed at establishing a more transparent and effective framework for patent rights.
5 Dec 22
The European Commission sends a Statement of Objection to a drug manufacturer accusing it of regulatory gaming and denigration of competitors in breach of Article 102 TFEU
On October 10, 2022, the European Commission sent a Statement of Objection to Teva accusing the company of denigrating a competing product and of “regulatory gaming” in management of the life cycle of its multiple sclerosis drug Capoxone, conduct deemed abusive pursuant to Article 102 of the Treaty on the Functioning of the European Union.
7 Feb 22
Digitization of Instructions for Use: the European Commission has endorsed a new Implementing Regulation on the use of electronic instructions for use (eIFUs) of medical devices
On December 14 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council relating to electronic instructions for use of medical devices.
4 Feb 22
IVD devices: Extension of timelines for the application of Regulation (EU) 2017/746
Regulation (EU) 2022/112 of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices was published on January 25, 2022.
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the operational and practical implementation of Articles 13&14 and other related obligations for importers and distributors under MDR and IVDR Regulations
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.
The European Commission’s Medical Device Coordination Group (MDCG) endorsed a new guidance on the classification of medical devices
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
...
Read more
Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

Close
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
June 30, 2023
Payback for medical devices: on June 28 Italian parliament approved the Law which, among other things, extends the deadline for the payment of the amount reduced by 52% from June 30th to Jul...
June 20, 2023
Clinical investigations on medical devices: four ministerial decrees setting out procedures for submitting applications/notifications and requirements for facilities and assessing persons, i...
Search by...
Search
Follow us on
Follow us on