Decentralised recognition procedure 2024

02 May 2025

Under the decentralised procedure (DCP), it is possible to apply for authorisation in several EU (EEA) countries simultaneously. Unlike the mutual recognition procedure, this procedure does not require authorisation in an EU (EEA) country beforehand. The reference member state (RMS) is responsible for completion of the decentralised procedure and the scientific assessment of the application.

Status for 2024 up to and including 4th quarter: Denmark has initiated 71 human DCP procedures and 1 veterinary DCP procedures, which is respectively 5 % and 1 % of all assigned DCP procedures in 2024.

Figure 1: Amount of initiated DCP procedures

[View table 1 – Initiated DCP procedures] 

Figur 2: Andel af påbegyndte humane DCP RMS sager

Table 1: Amount of initiated human DCP procedures

Number of human DCP procedures

2023

2024

Initiated procedures with DK as RMS

Total amount of procedures

Initiated procedures with DK as RMS

Total amount of procedures

1st quarter

28

356

15

368

2nd quarter

21

288

10

288

3rd quarter

18

301

29

327

4th quarter

14

250

17

327

Total

81

1.195

71

1.310

Figure 3: Share of initiated veterinary DCP procedures

Table 2: Amount of initiated veterinary DCP procedures

Number of veterinary DCP procedures

2023

2024

Initiated procedures with DK as RMS

Total amount of procedures

Initiated procedures with DK as RMS

Total amount of procedures

1st quarter

0

19

0

18

2nd quarter

0

8

1

16

3rd quarter

0

20

0

14

4th quarter

0

21

0

26

Total

0

68

1

74

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