Regulatory & compliance

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

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

Dutch Minister to explore possibility of compulsory licenses and pharmacy preparations

Anna-Maria Withagen

The Dutch Minister of Medical Care, Bruno Bruins, announced that he is going to explore the possibility of granting compulsory licenses in order to make pharmaceutical companies lower the prices of certain medicines they offer. During a debate, Bruins said that, although the instrument has not been used in the previous years, this does not Read More

French Competition Authority launches sector inquiry into medicinal products and biomedical laboratories

Patricia Carmona Botana

On 20 November 2017, the French Competition Authority (FCA) launched a sector inquiry into medicinal products and medical biology (biomedical) laboratories in France.  As previously announced, the inquiry aims to address the challenges that the sector entails for the French insurance system and public health and to assess the feasibility of more competitive conditions with 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