MRP and DCP new applications in 2007

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1 New Active Substance procedures finalised in MRP DCP Repeat Use Initial Application

2 New Active Substance Mutual Recognition Procedures finalised in 7 by RMS (Total 6) Repeat Use Initial Application 3 3 DE ES SE

3 New Active Substance Decentralised Procedures finalised in 7 by RMS (Total ) 8 Initial Application UK

4 DCP and MRP New Active Substances New Application Repeat Use MRP: Xenon (33Xe) (LENOXe % (V/V)) Yellow-fever virus, life attenuated (Stamaril) Rupatadine as fumarate (Rupafin mg comprimidos) Zanamivir (Relenza) Escitalopram (Cipralex) Docosanol (Healip) DCP: Dextriferron (Ferinject)

5 Abridged Mutual Recognition Procedures finalised in 7 (Total 3) 38 6% % 3% 8 Initial Application Multiple (Copy) application Repeat Use

6 Abridged Decentralised Procedures finalised in 7 (Total 36) 3 38% 6% Initial Application Multiple (Copy) application

7 Known Active Substance procedures finalised in MRP DCP Repeat Use Multiple (Copy) Application 9 Initial Application 37

8 Line Extension procedures finalised in MRP DCP Repeat Use 9 Multiple (Copy) Application 3 Initial Application 8 6

9 Mutual Recognition Procedures finalised in 7 (tot: ) Full dossier (Article 8.3(i) Directive /83/EC) Informed Consent (Article c Directive /83/EC) Bibliographic (Article a Directive /83/EC) Generic (Article. and. Directive /83/EC) Fixed Combination (Article b Directive /83/EC) Hybrid (Article.3 Directive /83/EC) Similar Biological (Article. Directive /83/EC) MRP

10 Decentralised Procedures finalised in 7 (tot: 39) 3 Full dossier (Article 8.3(i) Directive /83/EC) Informed Consent (Article c Directive /83/EC) Bibliographic (Article a Directive /83/EC) Generic (Article. and. Directive /83/EC) Fixed Combination (Article b Directive /83/EC) Hybrid (Article.3 Directive /83/EC) 7 9 Similar Biological (Article. Directive /83/EC) DCP

11 Mutual Recognition procedures finalised in 7 (tot: ) Herbal 8 Chemical Substance 36 Biological: Blood Product 3 8 Biological: Vaccine Biological: Other Homeopathic MRP

12 Decentralised procedures finalised in 7 (tot: 39) 39 Herbal 3 7 Chemical Substance Biological: Blood Product 7 Biological: Vaccine Biological: Other 7 Homeopathic DCP

13 MRP and DCP procedures finalised in MRP DCP Non Prescription* 8 9 Prescription only* *As approved by the Reference Member State

14 Decentralised procedures finalised in 7 (Tot: 39) 8 % 88% 3 Outcome Day Outcome Day Outcome Day

15 Decentralised procedures finalised in 7 per RMS FI, 8 NO, UK, 9 AT, 6 BE, FR, 3 DE, 88 % SE, 8 % 7% PL, PT, 7% % CZ, 3 NL, 6 DK, 86

16 FI, Mutual Recognition Procedures finalised in 7 per RMS NO, IE, AT, SK, IT, ES, 3 UK, 9 FR, DE, 6 7% % % SE, 6 % % PT, 7 IS, 8% % CZ, HU, 3 NL, 3 EE, 3 DK, 8

17 CMD(h) 6-day Referral Procedures - 7 Procedures referred to CMD(h) in 7 - Per Type of Procedure (MRP/DCP) * * The numbers include 7 procedures referred to the CMD(h) on identical grounds 3 3 MRP DCP Jan-7 Feb-7 Mar-7 Apr-7 May-7 Jun-7 Jul-7 Aug-7 Sep-7 Oct-7 Nov-7 Dec-7 Total

18 CMD(h) 6-day Referral Procedures - 7 Procedures referred to CMD(h) in 7 - Per Type of Procedure (MRP/DCP) DCP MRP 3 3 (8.8%) Finalised in 7 Referred to CMD(h) in 7 Referred to CHMP following CMD(h) referral 6 7 Referred to CMD(h) CHMP Arbitration 6

19 CMD(h) 6-day Referral Procedures - 7 Procedures referred to CMD(h) in 7 - Per Type of product Chemical Substance Biological Biological (other) Blood product 66

20 CMD(h) 6-day Referral Procedures - 7 Procedures referred to CMD(h) in 7 - Per Legal Basis * 3 Generic Full dossier Article (3) Bibliographic Fixed combination 36 8

21 CMD(h) 6-day Referral Procedures - 7 Procedures referred to CMD(h) in 7 - Per Therapeutic Area 3 8 C N J 6 R G V A M C: Cardiovascular System 9 N: Nervous System J: Antiinfectives for Systemic Use R: Respiratory System G: Genito Urinary System & Sex Hormones V: Various A: Alimentary Track & Metabolism M: Musculo-Skeletal System L: Antineoplastic & Immunomodulating Agents S: Sensory Organs L S

22 CMD(h) 6-day Referral Procedures - 7 Procedures referred to CMD(h) in 7 - Per Therapeutic Area C9: Agents acting on the Renin-angiotensin System R3: Drugs for Obstructive Airways J: Antibacterials for Systemic Use N: Analgesics G3: Sex Hormones & Modulators of the Genital System C: Lipid Modifying Agents A: Drugs for Acid Related Disorders C3: Diuretics C7: Betablocking Agents M: Antiinflammatory & Antirheumatic Products N: Anesthetics N: Psycholeptics N6: Psychoanaleptics V3: All other therapeutic products V: Diagnostic Agents A: Antiemetics & Anti-nauseants C: Antihypertensives G: Genito Urinary System & Sex Hormones J: Antimycotics for Systemic Use J: Antivirals for Systemic Use J6: Immune Sera & Immunoglobulins J7: Vaccines L: Endocrine Therapy M3: Muscle Relaxants R6: Antihistamines for Systemic Use S: Ophtalmologics V: Various 3 3 C9 R3 8 J N G3 C A C3 8 C7 M N N N6 V3 V 6 A C G J J J6 6 J7 L M3 R6 S V

23 CMD(h) 6-day Referral Procedures - 7 Procedures referred to CMD(h) in 7 - Per Grounds 6 3 BE S&E SPC 9 Efficacy Quality Safety Harmonisation 9 Non-Clinical PL

24 CMD(h) 6-day Referral Procedures - 7 Per Outcome (procedures referred to CMD(h) in 6 & 7) - Overview Agreement Reached CHMP Arbitration Jan-7 Feb-7 Mar-7 Apr-7 May-7 Jun-7 Jul-7 Aug-7 Sep-7 Oct-7 Nov-7 Dec-7 TOTAL

25 CMD(h) 6-day Referral Procedures - 7 Per Outcome (procedures referred to CMD(h) in 6 & 7) Agreement Reached in CMD(h) CHMP Arbitration Jan-7 Feb-7 Mar-7 Apr-7 May-7 Jun-7 Jul-7 Aug-7 Sep-7 Oct-7 Nov-7 Dec-7 TOTAL 3 Referred in 6 Referred in Jan-7 Feb-7 Mar-7 Apr-7 May-7 Jun-7 Jul-7 Aug-7 Sep-7 Oct-7 Nov-7 Dec-7 TOTAL Referred in 6 Referred in 7

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