Medicines for human use

In the case of assigned (European) scientific advice it is striking that a relatively large number of new countries have joined the Scientific Advice Working Party (SAWP), namely Croatia, Poland, Lithuania and Malta, and that these immediately carried out a significant number of procedures. It is clear that the leaders from last year have had to relinquish ground to the middle group and these new members. The number of procedures is distributed across the participating countries in a much more balanced way than in previous years.

This shows that the network as a whole has been strengthened and that countries which played no, or a smaller, role up to now have also started participating. The Netherlands shares third place with Austria, just behind Germany and the United Kingdom, and has been almost able to retain its relative share of 10%, despite this trend. It is striking that, despite the levelling trend, Ireland, France and Norway have managed to increase their share significantly.

The number of times that scientific advice was given nationally has also slightly increased. An element of this is tailor-made advice to encourage innovation at universities and small businesses. The MEB also carried out a regulatory test 13 times in 2018 for drug rediscovery applications to ZonMW and this figure is not included in the table.

The number of parallel import applications has increased substantially compared to last year. In particular there has been an increase in applications whereby the Dutch reference product was not exactly the same.

The number of national procedures has stayed approximately the same over the years. In the majority of cases applicants preferred a European procedure so that the product could be immediately launched onto the European market.

The number of concluded cases is gradually growing. This relates to authorisation applications, applications for expansion of indication, as well as minor variations, such as changing a manufacturer in the dossier.

The number of registered marketing authorisations has gradually increased over the years by between 50 and 100 per year. Although a large number of marketing authorisations are withdrawn every year as well, the number of newly granted marketing authorisations is still always greater.

The identification and assessment of adverse reactions during the entire life cycle of a medicine is one of the MEB's core tasks. On the instructions of the MEB the Netherlands Pharmacovigilance Centre Lareb maintains a record of all possible adverse reactions in the Netherlands. In a European context the Netherlands is responsible for monitoring 89 active substances.

In the event of urgent and/or important safety issues, healthcare practitioners are informed by means of a letter, referred to as 'Direct Healthcare Professional Communication (DHPC)'.