Table 3.

Other determinants of licensing failure during CMDh procedures

Category	Subcategory	Total	Licensing failure	Percent	RR (95 % CI)
Procedure type	DCP	135	29	21.5 %	Ref
	MRP	242	41	16.9 %	0.8 (0.5–1.2)
Period	2006	86	14	16.3 %	Ref
	2007	93	23	24.7 %	1.6 (0.9–2.8)
	2008	84	11	13.1 %	0.8 (0.4–1.7)
	2009	44	5	11.4 %	0.7 (0.3–1.8)
	2010	15	5	33.3 %	2.1 (0.9–4.9)
	2011	15	4	26.7 %	1.7 (0.6–4.4)
	2012	20	2	10.0 %	0.6 (0.2–2.5)
	2013	20	6	30.0 %	1.9 (0.8–4.2)
Prescription status (in RMS)	Prescription only	356	65	18.3 %	Ref
	Non-prescription	21	5	23.8 %	1.3 (0.6–2.9)
Legal basis	Art. 10.1—Generic	248	50	20.2 %	Ref
	Art. 8.3—Full dossier	63	4	6.3 %	0.3 (0.1–0.8)
	Art. 10.3—Hybrid	29	8	27.6 %	1.4 (0.7–2.6)
	Art. 10a—Well-established use (Bibliographic)	29	8	27.6 %	1.4 (0.7–2.6)
	Art. 10b—Fixed combination	8	0	0.0 %	NA
Active substance type	Small molecules	361	68	18.8 %	Ref
	Biologicalsa	16	2	12.5 %	0.7 (0.2–2.5)
Route of administration	Oral	264	48	18.2 %	Ref
	Injectables	40	4	10.0 %	0.6 (0.2–1.4)
	Other systemic	30	6	20.0 %	1.8 (0.8–3.7)
	Inhaled	16	5	31.3 %	1.7 (0.8–3.7)
	Topical	16	3	18.8 %	1.0 (0.4–2.0)
	Other	11	4	36.4 %	2.0 (0.9–4.6)
ATC level	C—Cardiovascular system	88	23	26.1 %	Ref
	N—Nervous system	76	17	22.4 %	0.9 (0.5–1.5)
	J—Anti-infectives for systemic use	38	4	10.5 %	0.4 (0.1–1.1)
	A—Alimentary tract and metabolism	34	4	11.8 %	0.5 (0.2–1.2)
	L—Antineoplastic and immunomodulating agents	30	1	3.3 %	0.1 (0.0–0.9)
	R—Respiratory system	30	9	30.0 %	1.1 (0.6–2.2)
	G—Genitourinary system and sex hormones	29	1	3.4 %	0.1 (0.0–0.9)
	M—Musculoskeletal system	21	3	14.3 %	0.5 (0.2–1.7)
	Other	28	5	17.9 %	0.7 (0.3–1.6)
	Unknownb	3	3	100 %
RMS	Other	86	22	25.6 %	Ref
	The Netherlands	81	4	4.9 %	0.2 (0.1–0.5)
	Germany	68	9	13.2 %	0.5 (0.3–1.1)
	Denmark	54	29	53.7 %	2.1 (1.4–3.2)
	UK	51	6	11.8 %	0.5 (0.2–1.1)
	Sweden	37	0	0.0 %	NA

^aTeicoplanin included in the biologics group

^bAll Article 8.3 procedures (‘full dossiers’) that did not receive marketing authorisation (excluded from analysis)