Regulatory & compliance

Getting ready for the EU MDR: Obligations for economic operators

Marco de Morpurgo

The Medical Devices Regulation (MDR) entered into force on 25 May 2017 providing for a three year transitional period until its full application as of 26 May 2020. While there is still time left before 2020, preparation is crucial especially for economic operators. The MDR will bring important changes to the current EU regulatory landscape Read More

Brexit and the medical devices industry: coping with uncertainty

Jacqueline Bore

With just 281 days left to go before the United Kingdom formally leaves the European Union on 29 March 2019 the medical devices industry still faces much uncertainty.  Any deal for the medical devices sector must be hammered out by October this year to give the EU parliament time to ratify its terms before next Read More

Dutch Parliament adopts bill to amend Medicines Act

Iradj Nazaryar

At the end of April 2018, the Dutch House of Representatives adopted a legislative proposal to amend the Dutch Medicines Act (DMA). The Bill increases the maximum statutory amount for administrative fines for violations of the DMA, currently set at EUR 450,000, to the amount determined for the sixth category in Article 23 of the Read More

Agreement between the Netherlands and the EMA on the hosting of the EMA published

Iradj Nazaryar

On 7 June 2018, the Agreement between the Kingdom of the Netherlands and the European Medicines Agency on the hosting of the European Medicines Agency was published in the Dutch Treaty Series. The object and purpose of the agreement is to implement Protocol No 7 on the Privileges and Immunities of the European Union and Read More

ANSM clarifies that it does not recommend “neutral packaging” of medicinal products in the midst of pharma industry criticism

Eveline Van Keymeulen

Yesterday, the French National Agency for Medicines and Health Products Safety (ANSM) provided some clarifications with respect to its Recommendations for applicants and holders of marketing authorisations on the labelling and packaging of human medicinal products dispensed in solid oral form and its Recommendations on the choice of medicinal product names (dated February 2018) (see our Read More