Assessment times for issuance of marketing authorisations in Concerned Member State cases

Updated 11 September 2026

Under the mutual recognition procedure and the decentralised procedure, we have 30 days to issue a marketing authorisation from the date when we receive an acceptable Danish summary of product characteristics (SmPC) or notification that the medicinal product is not to be marketed in Denmark and therefore a marketing authorization must be issued without Danish product characteristics (SmPC).

Status in 2026 as at end-June 2026: 77 % of the cases finished within the performance requirement's maximum of 30 days (44 days on average):

• Human medicines: 75 % of the cases finished within the performance requirement's maximum of 30 days (46 days on average).

• Veterinary medicines: 100 % of the cases finished within the performance requirement's maximum of 30 days (18 days on average).

We expect to reach 95% compliance in 2027.

Chart 1: Average assessment times for issuance of marketing authorisations with Denmark as Concerned Member State (CMS)

Table 1. Concerned member state cases

	Average assessment time	Target days	Difference between assessment time and target days	No. of cases measured No. of Drug IDs	No. of cases within 30 days	Share of cases within 30 days in per cent
Concerned Member State cases	Average assessment time	Target days	Difference between assessment time and target days	No. of cases measured No. of Drug IDs	No. of cases within 30 days	Share of cases within 30 days in per cent
3rd quarter 2024	116	30	86	150	59	39
4th quarter 2024	91	30	61	161	72	45
1st quarter 2025	63	30	33	197	136	69
2nd quarter 2025	39	30	9	145	118	81
3rd quarter 2025	36	30	6	122	92	75
4th quarter 2025	31	30	1	119	97	82
1st quarter 2026	33	30	3	111	94	85
2nd quarter 2026	52	30	22	148	105	71

Table 2. Concerned member state cases – Human medicines

	Average assessment time	Target days	Difference between assessment time and target days	No. of cases measured No. of Drug IDs	No. of cases within 30 days	Share of cases within 30 days in per cent
Concerned Member State cases - HUM	Average assessment time	Target days	Difference between assessment time and target days	No. of cases measured No. of Drug IDs	No. of cases within 30 days	Share of cases within 30 days in per cent
3rd quarter 2024	128	30	98	126	39	31
4th quarter 2024	95	30	65	152	66	43
1st quarter 2025	69	30	39	178	117	66
2nd quarter 2025	41	30	11	130	105	81
3rd quarter 2025	36	30	6	112	86	77
4th quarter 2025	28	30	-2	108	90	83
1st quarter 2026	35	30	5	101	84	83
2nd quarter 2026	54	30	24	142	99	70
3rd quarter 2024	128	30	98	126	39	31

Table 3. Concerned member state cases – Veterinary medicines

	Average assessment time	Target days	Difference between assessment time and target days	No. of cases measured No. of Drug IDs	No. of cases within 30 days	Share of cases within 30 days in per cent
Concerned Member State cases - VET	Average assessment time	Target days	Difference between assessment time and target days	No. of cases measured No. of Drug IDs	No. of cases within 30 days	Share of cases within 30 days in per cent
3rd quarter 2024	57	30	27	24	20	83
4th quarter 2024	19	30	-11	9	6	67
1st quarter 2025	10	30	-20	19	19	100
2nd quarter 2025	17	30	-13	15	13	87
3rd quarter 2025	37	30	7	10	6	60
4th quarter 2025	56	30	26	11	7	64
1st quarter 2026	18	30	-12	10	10	100
2nd quarter 2026	20	30	-10	6	6	100

The Danish Medicines Agency has established a best practice agreement on the issuance of marketing authorisations in connection with MRP/DCP applications where Denmark is Concerned Member State. According to this agreement, the maximum assessment time allowed is 30 days from the date on which we receive an acceptable Danish version of the authorised SmPC or notification that the medicinal product is not to be marketed in Denmark until issuance of a marketing authorisation.

For further information, please contact Send an email

Assessment times for issuance of marketing authorisations in Concerned Member State cases

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