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Centralised authorisation procedure 2019

25 September 2019, Updated 20 May 2020

The Danish share of assignments in the European pharmaceutical collaboration

The Danish Medicines Agency should have the greatest possible influence on decisions regarding new medicinal products and thereby the greatest possible influence on the future development of the European market for medicinal products.

Status for 2019 up to and including 4rd quarter

Denmark was assigned 21 human rapporteur/co-rapporteur cases and 4 veterinary rapporteur/co-rapporteur case, which is respectively 7 % and 7 % of all assigned central procedure cases in 2019.

Figure 1: Amount of assigned (co)rapporteurships in the EU in 2019 up to and including 4rd quarter

Figure 2. Share of human Rap/Co-rap cases

Table 1: Assigned human Rapporteur/co-rapporteur cases

Number of human procedures

2018

2019

Cases with DK as Rap/Co-rap

Total amount of cases

Cases with DK as Rap/Co-rap

Total amount of cases

1st quarter

2

2

5

70

2nd quarter

7

7

2

72

3rd quarter

4

4

7

77

4th quarter

5

5

7

64

Total

18

18

21

283

Figure 3. Share of veterinary Rap/Co-rap cases

Table 2: Assigned veterinary Rapporteur cases/co-rapporteur cases

Number of veterinary procedures

2018

2019

Cases with DK as Rap/Co-rap

Total amount of cases

Cases with DK as Rap/Co-rap

Total amount of cases

1st quarter

0

0

0

14

2nd quarter

1

1

3

26

3rd quarter

0

0

0

8

4th quarter

4

4

1

8

Total

5

5

4

56