In order to be allowed to market medicines for human use, a pharmaceutical company requires a marketing authorisation. In the Netherlands the MEB issues these authorisations for regular medicines and botanicals (herbal medicines).

Medicines for human use 2018: regular medicines

Medicines can be authorised for the market via a centralised procedure (CP), a mutual recognition procedure or a decentralised procedure (MRP/DCP), or a national procedure.

(Co-)rapporteurships assigned via the centralised procedure (CHMP)
LandAantal
Zweden24
Nederland23
Duitsland19
Oostenrijk18
Spanje16
Denemarken15
Frankrijk14
Ierland12
Polen12
Finland10
Tsjechië10
Noorwegen9
Portugal8
Italië7
Hongarije7
Estland6
IJsland6
België5
Letland5
Malta3
Kroatië2
Roemenië2
Griekenland1
Litouwen1
Slovenië1
Slowakije1
Verenigd Koninkrijk1
Bulgarije0
Cyprus0
Luxemburg0

The number of centralised (co-)rapporteurships assigned to the MEB in 2018 increased substantially compared to 2017. The MEB is in second place, just behind Sweden, and is followed at some distance by Germany, Austria and Spain.

It is striking that Spain has acquired a relatively large share and that the United Kingdom has performed a lot less work due to Brexit. Another striking feature is the relatively large spread of the centralised (co-)rapporteurships. A lot of countries are participating and that means that the network as a whole appears to have become stronger. The MEB has also cooperated with other countries in multinational assessment teams.

Source: EMA Source table as .csv (498 bytes)
Assigned pharmacovigilance rapporteurships (PRAC)
LandAantal
Zweden30
Nederland29
Duitsland20
Frankrijk20
Spanje19
Denemarken12
Oostenrijk10
Finland8
Ierland8
Polen6
België5
Italië5
Noorwegen5
Verenigd Koninkrijk3
Hongarije2
Letland2
Litouwen2
Portugal2
Tsjechië2
Kroatië1
Slowakije1
Bulgarije0
Cyprus0
Estland0
Griekenland0
IJsland0
Luxemburg0
Malta0
Roemenië0
Slovenië0

The PRAC (Pharmacovigilance Risk Assessment Committee) plays an important role in terms of supervising the risks of medicines for people in Europe. The PRAC meets on a monthly basis at the European Medicines Agency (EMA). The PRAC makes recommendations to the Committee for the Assessment of Medicinal Products for Human Use (CHMP) and The European decision-making body CMDh about the risks of medicines which are authorised in the European Union.

In terms of the number of PRAC rapporteurships assigned in 2018, the Netherlands is in second place, just behind Sweden, and is followed at some distance by Germany, France and Spain. The number of rapporteurships for the Netherlands has remained stable compared to 2017. It is striking that one third of the network does not participate in PRAC rapporteurships, often due to limited capacity, and that the United Kingdom already carried out fewer PRAC rapporteurships due to its impending Brexit.

Source: EMA Source table as .csv (494 bytes)
Applications initiated via the decentralised (DCP) and mutual recognition procedure (MRP) with share MEB and RMS
LandAantal
Nederland269
Duitsland249
Portugal158
Verenigd Koninkrijk136
Denemarken105
Zweden93
Spanje70
Tsjechië50
Oostenrijk50
Hongarije45
Malta40
Ierland32
Finland18
Polen15
Estland15
Kroatië13
Noorwegen12
Letland11
Frankrijk8
België7
Slowakije6
IJsland4
Slovenië4
Italië3
Griekenland1
Bulgarije0
Cyprus0
Litouwen0
Luxemburg0
Roemenië0

As Reference Member State, the majority of procedures in mutual recognitions and decentralised procedures were started at the MEB in 2018, compared with the other European countries. The number of procedures was stable during the years at almost 20 percent. The Netherlands is followed closely by Germany and Portugal is also making a significant contribution.

Source: CMDh Source table as .csv (510 bytes)
Assigned Scientific Advice applications - European
20172018
AT166130
DE153142
DK15360
UK142132
NL135130
BE124103
SE9878
IT9262
ES6341
FR6180
FI6060
IE5170
PT5149
IS4952
NO3445
HR018
PL018
LT017
MT014

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.

Source: EMA Source table as .csv (210 bytes)
Opened cases national scientific advice
Scientific adviceCustomised scientific advice
20167812
201710112
20181107

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.

Source: MEB Source table as .csv (86 bytes)
Parallel import applications
201620172018
Number of applications428447520

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.

Source: MEB Source table as .csv (53 bytes)
Applications via the national procedure
201620172018
Number of applications466657

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.

Source: MEB Source table as .csv (50 bytes)
Concluded cases, including variations
201620172018
Number of concluded cases180601966425070

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.

Source: MEB Source table as .csv (62 bytes)
Number of registered marketing authorisations On 31 December 2018
201620172018
Number of registered marketing authorisations140041407814236

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.

Source: MEB Source table as .csv (82 bytes)
Direct Healthcare Professional Communications
201620172018
Number of DHPCs302131

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)'.

Source: MEB Source table as .csv (43 bytes)