DOCUMENTATION ON AUTHORISATION OF VETERINARY MEDICINAL PRODUCTS

 

This portal is offered to you by EUDRAVET free of charge

 

This portal contains a selection from the website of  the European Medicines Evaluation Agency (EMEA)

.

 

Only those items that are of direct relevance to veterinary product authorisation are included.

These items are given below.

 You can open any item directly by clicking on it.

 

For a comprehensive overview of all documentation on medicinal products, the full website of EMEA can be assessed under

www.emea.europa.eu  (Deep links below)

Veterinary legislation is contained in the website of the Pharmaceutical Unit of the European Commission under http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm  (Deep links below)

The comprehensive EU legislation can be found by clicking on the link

EUDRALEX

 

Back to eudravet homepage: click here

 

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Veterinary Medicines

CVMP Press Releases

 

Public Statements

Public Statements

Position Statements

 

EPARs for authorised medicines

Background

A-Z Listing of EPARs

 

Withdrawals and Refusals

Withdrawals of Application

Refusals of Marketing Authorisation

 

Maximum Residue Limits

MRL Summary Reports
Substances A-F
Substances G-L
Substances M-R
Substances S-Z
Summary Opinions

 

Referrals

List of referred applications

 

Veterinary Guidelines

Background

Efficacy

Immunologicals

Quality

Safety & Residues

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH)
Draft Guidelines
Adopted Guidelines

 

Summaries of Opinion

Introduction

List of Products

 

CVMP Working Parties

Efficacy Working Party (EWP)
Points to Consider
Concept Papers
Draft Guidelines
Adopted Guidelines
Workprogramme

Immunologicals Working Party (IWP)
Points to Consider
Concept Papers
Draft Guidelines
Adopted Guidelines
Workprogramme

Pharmacovigilance Working Party (PHVWP)
Workprogramme
Guidelines

Quality Working Party (QWP)
Points to Consider
Concept Papers
Draft Guidelines
Adopted Guidelines
Workplan

Safety (of Residues) Working Party (SWP)
Concept Papers
Draft Guidelines
Adopted Guidelines
Workprogramme
General Reporting

Environmental Risk Assessment Working Party (ERA)
General Reporting
Workprogramme

Scientific Advisory Group on Antimicrobials (SAGAM)
Antimicrobial Resistance
Workprogramme

 

General guidance

CVMP Rules of Procedure

Position papers

General reporting

Draft Guidelines

Adopted Guidelines

 

Application Procedures

Fees payable to EMEA

Pre-Submission Guidance
Introduction
List of Questions and Answers
Pre-submission Meeting Request form

Quality Review of Documents (QRD)
Introduction
Product Information Templates
QRD Reference Documents
Other guidelines
EU legislation

Scientific Advice
Guidance documents
Workprogramme of the CVMP Scientific Advice Working Party

 

Standard Operating Procedures (SOPs)

Listing of standard operating procedures (SOPs) and work instructions (WINs)

 

Parallel Distribution

Introduction

Notification Templates

Questions & Answers

 

 

 

<!doctype html public "-//w3c//dtd html 4.0 transitional//en">DEEP LINKS TO EU-COMMISSION DG ENTERPRISE WEBSITE:                              


The latest news on Pharmaceuticals and relevant uploads to the site.

EudraLex Collection - Volumes 1 to 10 / EudraLex CD

The Community Register

Commission Decisions of the last six months

Maximum Residue Limits