Decentralised recognition procedure 2016

Updated 06 March 2017

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 2016 up to and including 4thquarter

Denmark has initiated 112 human DCP procedures, which is 9 % of all assigned human DCP procedures in 2016. Denmark has not initiated veterinary DCP procedures in 2016.

Figure 1: Amount of initiated DCP procedures in 2016, up to and incl. Q4

Figure 1. Amount of assigned rapporteur/corapporteur cases in the EU in 2016 up to and including 3rd quarter

 

Figure 2: Share of initiated human DCP procedures in 2016, up to and incl. Q4

Figure 2. Share of human rapporteur/corapporteur cases in the EU in 2016 up to and including 1st quarter

 

Table 1: Amount of initiated human DCP procedures

Number of human DCP procedures

2015

2016

Initiated procedures with DK as RMS

Total amount of procedures

Initiated procedures with DK as RMS

Total amount of procedures

1st quarter

20

352

17

301

2nd quarter

23

312

22

308

3rd quarter

23

304

41

317

4th quarter

35

340

32

299

Total

101

1308

112

1225

 

Figure 3: Share of initiated veterinary DCP procedures in 2016, up to and incl. Q4

Figure 3. Share of veterinary rapporteur/corapporteur cases in the EU in 2016 up to and including 1st quarter

 

Table 2: Amount of initiated veterinary DCP procedures

Number of veterinary DCP procedures

2015

2016

Initiated procedures with DK as RMS

Total amount of procedures

Initiated procedures with DK as RMS

Total amount of procedures

1st quarter

0

29

0

29

2nd quarter

0

22

0

15

3rd quarter

0

31

0

24

4th quarter

0

24

0

22

Total

0

106

0

91