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Variations & worksharing An industry perspective Rmon van Aubel European Medicines Agency/IFAH-Europe Info Day 7-8 March 2013, London 1 Variations - Regulation Com m ission Regulation ( EU) No 1 2 3 4 / 2 0 0 8 Since 1

  1. Variations & worksharing An industry perspective Rémon van Aubel European Medicines Agency/IFAH-Europe Info Day 7-8 March 2013, London 1

  2. Variations - Regulation  Com m ission Regulation ( EU) No 1 2 3 4 / 2 0 0 8 – Since 1 January 2010 – Applicable to CAPs and MRP/ DCP products  Am endm ent 7 1 2 / 2 0 1 2 – Since 2 November 2012 – Extended to NAT products (with transition period) – Changes to “implementation” & amendment MA 2

  3. Variations – Com m ission Guidelines  Com m ission guidelines – 2010: Procedures & categories – 2013: Combined/ updated guideline  Public consultation – Article 4: “The commission shall, after consulting the Member States, the Agency and interested parties, draw up guidelines… .” – Short time line (1 month) – Industry comments/ suggestions reviewed by EC 3

  4. Variations – Com m ission Guidelines  I ncreased com plexity – Categories: high level, 107 (+ 10); total, 313 (+ 43) – More stringent conditions to allow for type IA – Introduction certain terms/ expressions  Possible consequences – Increased administrative burden – Discussions between applicants and regulators – Re-classifications and delayed procedures – Delay improved/ upgraded products to the EU market 4

  5. Variations – Com m ission Guidelines  Areas requested for change by industry – Administrative changes – Pharmacovigilance – Change to 1 national MAH not applicable to other member states in DCP/ MRP – “Type II umbrella” concept ( slight modifications to the manufacturing process/ testing without significant impact on quality/ safety/ efficacy ) – Single notification for change covering all MAs per CA ( notification removal TABST ) Exam ple of an “adm inistrative” change 5

  6. Variations - Exam ple Central AT BE BG CY CZ DK EE FI FR DE GR HU IE IS IT LV LT LU MT NL NO PL PT RO SK SI ES SE UK A.4 A.5.b 1 Bovilis BTV8 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 Equilis Prequenza 1 1 1 1 1 1 1 CAPs 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 3 Equilis Prequenza-Te 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 4 Nobilis IB 4-91 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 5 Nobilis Influenza H5N2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 6 Nobilis OR inac 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 7 Porcilis AR-T DF 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 8 Porcilis PCV 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Total 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4 6 DCP/MRP AT BE BG CY CZ DK EE FI FR DE GR HU IE IS IT LV LT LU MT NL NO PL PT RO SK SI ES SE UK A.4 A.5.b Nam e change of a 1 Bovilis Bovipast RSP 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 21 Nobilis Salenvac 1 1 1 1 1 1 22 Nobilis Salenvac T 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 4 Bovivac S 1 1 1 26 Ovipast Plus 1 1 1 1 1 34 Porcilis PRRS 1 1 1 1 1 1 1 1 1 1 1 1 1 6 Heptavac P plus 1 1 1 1 m anufacturing site 7 Nobilis CAV P4 1 1 1 1 1 1 1 13 Nobilis ND C2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 9 Nobilis E. coli inac 1 2 1 1 1 1 1 1 1 1 1 1 1 3 Bovilis IBR Marker Live 1 1 2 1 1 1 1 1 1 1 1 1 1 10 Nobilis IB Multi+ND+EDS 1 1 1 1 1 1 1 1 1 1 MRP/DCP 11 Nobilis Marexine CA126 1 1 1 1 1 1 1 1 1 1 1 1 1 14 Nobilis ND Lasota 1 1 1 1 15 Nobilis Paramyxo P201 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 16 Nobilis Reo ERS 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 18 Nobilis RT inac 1 1 1 1 1 1 1 1 1 1 1 1 1  19 Nobilis RT+IB Multi+G+ND 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Two classifications: 20 Nobilis RT+IB Multi+ND+EDS 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 23 Nobilis TRT live 1 1 1 1 25 Ovilis Enzovax 1 1 1 1 1 1 2 Bovilis BVD 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 5 Equilis Resequin ** 1 2 1 1 1 1 1 1 1 1 1 1 1 1 27 Porcilis Begonia Diluvac Forte 1 1 1 1 1 1 1 1 1 1 1 28 Porcilis Begonia IDAL 1 1 1 1 1 1 1 1 1 – Active substance (A.4), type IA 29 Porcilis Begonia Unisolve 1 1 1 1 1 1 1 1 30 Porcilis Ery 1 1 1 1 31 Porcilis Ery+Parvo 1 1 1 1 17 Nobilis Rhino CV 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 32 Porcilis M Hyo 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 33 Porcilis Parvo 1 1 1 1 1 1 12 Nobilis MG 6/85 1 1 1 1 1 1 1 1 1 1 1 1 24 Norvax Compact PD 1 1 1 1 – Finished product (A.5), Type IA 8 Nobilis Coryza 1 1 1 Total 15 25 0 4 7 13 5 9 17 27 19 6 15 0 23 5 5 19 3 19 8 6 23 0 8 6 21 8 21 15 31 National AT BE BG CY CZ DK EE FI FR DE GR HU IE IS IT LV LT LU MT NL NO PL PT RO SK SI ES SE UK A.4 A.5.b 1 Bovilis Blackleg 1 1 1 2 Bovilis Bovipast RSP 1 1 1 1 1 1 1 1 1 1 1 1 1 3 Bovilis BVD 1 1 1 1 1 1 1 1 1 4 Equilis Resequin ** 1 1 1 1 1 1 1 1 1 1 5 Heptavac P plus 1 1 1 1 1 1 1 1 6 Lambivac 1 1 1 1 7 Nobilis AE + Pox 1 1 1 1 1 1 1 1 1 1 1 8 Nobilis AE 1143 ** 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 9 Nobilis CAV P4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1  10 Nobilis Coryza 1 78 products (A.4., A.5, A.4+ A.5) 11 Nobilis Coryza Inac 1 1 1 1 12 Nobilis E. coli inac 1 1 1 1 1 1 1 1 13 Nobilis EDS inac 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 14 Nobilis Erysipelas 1 1 1 1 1 1 1 15 Nobilis FC Duck inac 1 1 16 Nobilis G+ND 1 1 1 1 17 Nobilis Gumboro 228E 1 1 1 1 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 1 1 1 18 Nobilis Gumboro D78 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 19 Nobilis Gumboro inac 1 1 1 1 1 1 1 1 1 20 Nobilis IB H120 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 21 Nobilis IB Ma5 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 22 Nobilis IB Ma5+ND Cl 30 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 23 Nobilis IB Multi inac 1 1 1 1 1 24 Nobilis IB Multi+G+ND 1 1 1 1 1 1 1 25 Nobilis IB Multi+ND 1 1 1 1 1 1 1 1 1 1 1  26 Nobilis IB Multi+ND+EDS 1 1 1 1 1 1 1 1 1 1 Three different types of registration 27 Nobilis IB+G+ND 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 28 Nobilis IB+ND 1 1 1 1 1 1 1 1 1 1 29 Nobilis IB+ND+EDS 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 National 30 Nobilis ILT 1 1 1 1 1 1 1 1 1 1 1 1 1 31 Nobilis Marexine CA126 1 1 1 1 1 1 1 1 1 1 1 32 Nobilis MG 6/85 1 1 1 1 1 1 1 1 1 33 Nobilis ND Broiler 1 1 1 1 34 Nobilis ND C2 1 1 1 1 1 35 Nobilis ND Clone 30 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 36 Nobilis ND Lasota 1 1 1 1 1 1 1 1 1 1 37 Nobilis ND+EDS 1 1 1 1 1 1 1 38 Nobilis Newcavac 1 1 1 1 1 1 1 1 1 1 1 1 1 1 39 Nobilis Paramyxo P201 1 1 1 1 1 40 Nobilis Reo 1133 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 41 Nobilis Reo 2177 1 1 1 42 Nobilis Reo ERS inac 1 1 1 43 Nobilis Reo inac 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 44 Nobilis Reo+IB+G+ND 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 45 Nobilis Rhino CV 1 1 1 46 Nobilis Rismavac 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 47 Nobilis Rismavac + CA126 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 48 Nobilis RT inac 1 1 1 1 1 1 1 1 49 Nobilis RT+IB Multi+G+ND 1 1 1 1 1 1 1 1 1 1 1 50 Nobilis RT+IB Multi+ND+EDS 1 1 1 1 1 51 Nobilis RTV 8544 1 1 1 1 1 1 1 1 1 1 52 Nobilis Salenvac 1 1 1 1 1 1 1 53 Nobilis Salenvac T 1 1 1 1 1 1 1 1 1 54 Nobilis SG 9R 1 1 1 1 1 1 1 1 1 1 1 1 55 Nobilis TRT live 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 56 Norvax Minova 4WD 1 1 57 Norvax Minova 6 1 1 58 Ovilis Enzovax 1 1 1 1 1 1 1 1 1 59 Ovipast Plus 1 1 1 1 60 Ovivac P plus 1 1 1 1 61 Porcilis AR-T (WO) 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 62 Porcilis Begonia Diluvac Forte 1 1 1 1 1 1 1 63 Porcilis Begonia IDAL 1 1 6 64 Porcilis Begonia Unisolve 1 1 1 1 1 65 Porcilis Ery 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 66 Porcilis Ery+Parvo 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 67 Porcilis M Hyo 1 1 1 68 Porcilis Parvo 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 69 Porcilis PRRS 1 1 1 1 1 1 1 1 1 1 1 1 Total

  7. Variations – Com m ission Guidelines  I m m unologicals – Changes with no impact on quality, safety or efficacy remain classified as type II – New/ upgraded categories on TSE certificates, which may lead to confusion and discussion Exam ples 7

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