Decentralised recognition procedure 2018

Updated 04 April 2019

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 2018 up to and including 4nd quarter

Denmark has initiated 76 human DCP procedures and 0 veterinary DCP procedure, which is respectively 7 % and 0 % of all assigned DCP procedures in 2018.

Figure 1: Amount of initiated DCP procedures

Number of DCP RMS cases by country at procedure level in 2018, up to and incl. Q1

Figure 2: Share of initiated human DCP procedures 

Share of human DCP RMS cases at procedure level in 2018, up to and incl. Q1

Table 1: Amount of initiated human DCP procedures

Number of human DCP procedures

2017

2018

Initiated procedures with DK as RMS

Total amount of procedures

Initiated procedures with DK as RMS

Total amount of procedures

1st quarter

17

229

18

299

2nd quarter

16

277

27

297

3rd quarter

23

299

18

225

4th quarter

19

278

13

272

Total

75

1083

76

1093

Figure 3: Share of initiated veterinary DCP procedures

Share of veterinary DCP RMS cases at procedure level in 2018, up to and incl. Q1

Table 2: Amount of initiated veterinary DCP procedures

Number of veterinary DCP procedures

2017

2018

Initiated procedures with DK as RMS

Total amount of procedures

Initiated procedures with DK as RMS

Total amount of procedures

1st quarter

0

23

0

21

2nd quarter

0

24

0

34

3rd quarter

0

18

0

18

4th quarter

1

35

0

34

Total

1

100

0

107