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Veterinary Medicinal Products
According to EU Directive 2001/82/EC (as amended by Directive 2004/28/EC of the European Parliament) on the Community code relating to veterinary medicinal products, veterinary medicinal products are defined as:
(a) any substance or combination of substances presented as having properties for treating or preventing disease in animals;
or
(b) any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
No veterinary medicinal product may be placed on the market of a Member State unless a marketing authorisation has been granted by the competent authorities of that Member State in accordance with this Directive.
The application for marketing authorisation shall include all the administrative information and scientific documentation necessary for demonstrating the quality, safety and efficacy of the veterinary medicinal product in question.
The application dossier for veterinary pharmaceutical products is presented in four parts.
Part 1 - Summary of the dossier (divided into 3 sub-sections. Parts 1A, 1B and 1C.)
- Part 1A consists of the administrative data/packaging/samples etc.
- Part 1B consists of the proposed Summary of Product Characteristics (SmPC), label and package insert.
- Part 1C consists of the Expert Reports and their tabular formats. There are separate expert reports on the chemical/pharmaceutical/biological, safety/residues and preclinical/clinical documentation.
Part 2 - Chemical, pharmaceutical and biological documentation
Part 3 - Safety and residues documentation
Part 4 - Pre-clinical and clinical documentation
- Ivowen Limited are able to advise companies on the documentation needed and the legislation to be followed to obtain a valid EU MA.
- We can prepare and/or review your application either to the Irish Competent Authority or any other Member State 's Competent Authority. We can also prepare, submit and manage marketing authorisation applications via the Mutual Recognition Procedure or Decentralised Procedure systems.
- We can advise you on all the steps that your company needs to take from a manufacturing point of view to comply with any EU Directives, Regulations and Notes for Guidance
- We can write or review your Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).
For more information please contact us. |
