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.
