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5 Jun 19
Breaking news on the supplementary protective certificate for medicinal products
On June 11, 2019, Regulation (EU) 2019/933 (“Regulation 2019/933”), amending Regulation (EC) No 2009/469 (“Regulation 2009/469”) concerning the supplementary protection certificate (“SPC”) for medicinal products, was published in the Official Journal of the European Union.
4 Jun 19
Substitutability of veterinary medicines: this is now also possible through the use of parallel imports
This is a period of profound changes in the veterinary medicines sector.
3 Jun 19
European Law 2018: amendments to the Drugs Code in regard to the implementation of the GMP
On May 26, 2019, Law No. 37 of May 3, 2019 (“European Law 2018 “) entered into force. Article 16 of this law provides for several amendments to Legislative Decree No. 219 of April 24, 2006 (“The Drugs Code“).
2 Jun 19
Selling of medicines through vending machines, clarifications from the Ministry
On 11 March 2019, the Ministry of Health issued a note in response to a request from Federfarma (i.e., the Italian federation representing private pharmacies that are affiliated with the Italian National Health Service) for an opinion on certain procedures relating to the sale and dispensing to the public of Sop medicines (i.e., drugs which can be bought without medical prescription), which include the use of vending machines.
1 Jun 19
Adverse reaction to medicines and pharmaceutical companies’ liability: valuable tips from the Court of Cassation
With Judgment no. 6587 of March 7 2019, the Italian Court of Cassation clarified the conditions for the liability of a medicine manufacturer in the event of rare adverse reactions.
9 Apr 19
EU General Court provides guidance to assess whether patent settlements between originator and generics infringe antitrust law (Servier)
On 12 December 2018 the General Court of the EU (“GC”) has passed a set of parallel judgments (we will referrer to Case T-691/14,Servier and Others v. Commission and Case T-684/144,Krka v. Commission) on the incompatibility with Article 101 TFEU of a number of settlement agreements in patent disputes between Servier, which is the originator of Perindopril (a drug primarily intended for the treatment of hypertension and heart failure), and five manufacturers of that drug’s generic versions.
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
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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.

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October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
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 ...
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