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Pág. 1 E-submissions for veterinary medicines dossiers EMEA, 07th May 2009 Pilot phase.

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Presentation on theme: "Pág. 1 E-submissions for veterinary medicines dossiers EMEA, 07th May 2009 Pilot phase."— Presentation transcript:

1 Pág. 1 E-submissions for veterinary medicines dossiers EMEA, 07th May 2009 Pilot phase

2 Pág. 2 Index 1.Objectives 2.Legal frame 3.Implantation schedule 4.Folders and files structure 5.Preliminary results of Pilot I

3 Pág. 3 1. Objectives 1.- To allow to the companies the submission of dossiers by using an electronic format (Non-eNTA) 2.- To allow the validation and assessment of such dossiers by using an electronic system. Benefits For the CompaniesFor AGENCY Administration procedures easier and faster. Logistic cost savings. Paper saving. Document management and store costs savings. Improvement on access to archived documents. Improvement on traceability of modifications. Document management and store costs savings.

4 Pág. 4 2. Legal frame Ley 11/2007, de 22 de junio, de Acceso Electrónico de los Ciudadanos a los Servicios Públicos: is the legal basis to develop the e-administración. Plan de desarrollo de la Ley 11/2007: gives a schedule to adapt to electronic mode more than 2400 administrative procedures from the State General Administration. Going to an Electronic Administration. Criteria of Safety, Normalization and Aplications Conservation will be observed (good practices related to data handling in administrative procedures),

5 Pág. 5 2. Legal frame Authorization, Registration and Farmacovigilance Directive 2001/82, modified Real Decreto 1246/2008, de 18 de julio, por el que se regula el procedimiento de autorización, registro y farmacovigilancia de los medicamentos veterinarios fabricados industrialmente: guarantee of quality, safety and efficacy of veterinary medicines manufactured industrially. Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios

6 Pág. 6 3. Implantation schedule - Previous technical works on systems and organization in AEMPS - Beginning of e- submissions - Consults and suggestions - Procedure debug Continuous improvemen t November 17th 2008:Beginning Pilot Phase I: 10 companies May 15th 2009: Pilot Phase II (10 more) June 30th 2009 System opened to all companies Tareas previas Pilot I-II Implementation for all companies PHASES FACTS

7 Pág. 7 4. Folders and files Non Immunologicals. 00-introduction 00-1-en-cover-letter 00-2-en-index 01-part1 01-en-index 01-a-administrative-data 01-a-1-en-fees 01-a-2-en-administrative-data 01-a-3-en-application-form-variations 01-b-spc-packaging-insert-labelling 01-b-1-en-spc 01-b-2-en-packaging-insert 01-b-3-en-labelling 01-b-4-en-mock-ups 01-c-expert-reports 01-c-1-en-quality 01-c-2-en-safety 01-c-3-en-efficacy 01-d-additional-info-answers 01-d-1-en-quality 01-d-2-en-safety 01-d-3-en-efficacy

8 Pág. 8 4. Folders and files 02-part2 02-en-index 02-a-quali-quantitative-particulars 02-a-1-en-composition 02-a-2-en-development-pharmaceutics 02-b-manufacturing-method-desc 02-b-1-en-manufacturing-formula 02-b-2-en-manufacturing-process 02-b-3-en-validation-studies 02-c-control-starting-materials 02-c-1-en-control-active-substances 02-c-2-en-control-excipients 02-c-3-en-containers 02-d-tse-measures 02-d-1-tse-measures 02-e-control-tests-intermediate-products 02-e-1-en-control-tests-intermediate-products 02-f-control-tests-finished-product 02-f-1-en-routinary-specifications 02-f-2-en-scientific-data 02-g-stability-tests 02-g-1-en-stability-active-substances 02-g-2-en-stability-finished-product 02-h-genetically-modified-organisms 02-h-en-organisms 02-i-other-information 02-i-1-en-other-information 02-j-bibliography-quality

9 Pág. 9 4. Folders and files 03-part3 03-en-index 03-a-safety-documentation 03-a-1-en-identification-active-substance 03-a-2-en-pharmacology 03-a-3-en-toxicity 03-a-4-en-other-effects 03-a-5-en-safety-for-users 03-a-6-en-ecotoxicity (ERA) 03-b-residue-testing 03-b-en-identification-active substance 03-b-en-residues-studies 03-b-en-routine-tests-detection-residues 03-c-bibliography-safety 03-d-bibliography-residues 04-part4 04-en-index 04-a-pre-clinical-requirements 04-a-1-en-pharmacology-bio- equivalence-if-appropriate 04-a-2-en-tolerance-target-species 04-a-3-en-resistances 04-b-clinical-requirements 04-b-1-en-general principles 04-b-2-en-trials-performance 04-c-bibliography-pre-clinical 04-d-bibliography-clinical

10 Pág. 10 4. Folders and files Immunologicals. 00-introduction 00-1-en-cover-letter 00-2-en-index 01-part1 01-en-index 01-a-administrative-data 01-a-1-en-fees 01-a-2-en-administrative-data 01-a-3-en-application-form-variations 01-b-spc-packaging-insert-labelling 01-b-1-en-spc 01-b-2-en-packaging-insert 01-b-3-en-labelling 01-b-4-en-mock-ups 01-c-expert-reports 01-c-1-en-quality 01-c-2-en-safety 01-c-3-en-efficacy 01-d-additional-info-answers 01-d-1-en-quality 01-d-2-en-safety 01-d-3-en-efficacy

11 Pág. 11 4. Folders and files 02-part2 02-en-index 02-a-quali-quantitative-particulars 02-a-1-en-composition 02-a-2-en-containers 02-a-3-en-pharmaceutic-developments 02-a-4-en-composition-batches-clinical-trials 02-b-finished-product-manufacturing-method-desc 02-b-1-en-finished-product-manufacturing-method-desc 02-c-control-starting-materials 02-c-1-en-listed-pharmacopeias 02-c-2-en-non-listed-pharmacopeias 02-d-tse-measures 02-d-1-en-tse-measures 02-e-production-control-tests 02-e-1-en-intermediate-products 02-f- finished-product-control-tests 02-f-1-en-finished-product-control-tests 02-g-stability-tests 02-g-1-en-stability-finished-product 02-h-bibliography-quality

12 Pág. 12 4. Folders and files 03-part3 03-en-index 03-a-laboratory-tests 03-a-1-en-laboratory-tests 03-b-field-studies 03-b-1-en-field-studies 03-c-ecotoxicity 03-c-en-ecotoxicity 03-d-bibliography-safety 04-part4 04-en-index 04-a-laboratory-tests 04-a-1-en-laboratory-tests 04-b-field-studies 04-b-1-en-field-studies 04-c-suplemmentary-docs 04-d-bibliography-efficacy

13 Pág. 13 Identification of CDs/DVDs Applicant: Name Name of VMP: Name Application nº: yyyyXXXXXX Variation code: yyyy/xxxbbb/cc/nnnn Application date : dd/mm/yyyy Type of application: (complete,generic,etc) Sequence: zzzz (being the first 0000) 4. Folders and Files Nº de CD (o DVD): 1/n

14 Pág. 14 5. Preliminary results Pilot I Nov 2008- Apr 2009: 41 dossiers 1 National 3 DCP 37 Variations (16 IA, 4 IB, 17 II) Participants Pilot I: 10 companies 6 Nationals: CALIER, CZ VETERINARIA, ESTEVE, HIPRA, SP VETERINARIA, SYVA 4 Multinationals: BOEHRINGER-INGELHEIM, FORT-DODGE, PFIZER, INTERVET-SCHERING- PLOUGH 60% companies had used the system at least once www.agemed.es

15 Pág. 15 THANK YOU FOR YOUR ATTENTION!


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