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E-submissions for veterinary medicines dossiers

EMEA, 07th May 2009

Pilot phase

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Index

1. Objectives

2. Legal frame

3. Implantation schedule

4. Folders and files structure

5. Preliminary results of Pilot I

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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 Companies For 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.

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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),

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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

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3. Implantation schedule

- Previous technical works on systems and organization in AEMPS

- Beginning of e- submissions

- Consults and suggestions

- Procedure debug

Continuous improvement

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

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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

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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

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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

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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

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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

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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

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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

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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

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THANK YOU FOR YOUR ATTENTION!