EU

Brexit: EMA’s regulatory guidance on centrally approved medicinal products – the present state of play

Jacqueline Bore

The champagne bottles have been drained in Amsterdam and tears dried in Milan and Bratislava but the serious work of mapping out the practical implications of Brexit continues at the European Medicines Agency (EMA). The EMA and the European Commission issued a Notice in May 2017 confirming that “unless the withdrawal agreement establishes another date” Read More

Suppliers of luxury goods can restrict online sales on (discernible) third-party platforms, says the Court of Justice

Florence Ninane

The European Court of Justice (ECJ) handed down yesterday its much awaited ruling in Coty Germany GmbH (C-230/16). It has clarified that a supplier of luxury goods can include a clause in selective distribution agreements prohibiting authorised distributors from selling those goods through non-authorised third-party platforms in a discernible manner, in order to preserve the Read More

European Commission clarifies framework applicable to food for special medical purposes

Patricia Carmona Botana

The European Commission recently published a Notice on the classification of Food for Special Medical Purposes (FSMP) that provides guidance to companies and national regulators on the legal framework applicable to FSMP and on the criteria that are required to classify a product as a FSMP (Notice). The Notice confirms that FSMP is in principle food Read More

EU Competitiveness Council to review Current Status of the Unitary Patent and Unified Patent Court

Laëtitia Bénard

The Council of the European Union has published a note, from the Presidency to the Council, entitled “Unitary Patent and Unified Patent Court – Information from the Presidency on the state of play”. The note relates to the upcoming meeting of the Competitiveness Council on 30 November, and explains as follows: “The Presidency will give Read More

European Medicines Agency heads for Amsterdam

Frits Gerritzen

Today the 27 member states of the European Union have decided on Amsterdam as the new home of the European Medicines Agency. The decision came after three rounds of voting, with Amsterdam eventually emerging the winner after tying with Milan on 13 votes each in the final round. It appears that Slovakia may have abstained. Read More