REGULATORY REQUIREMENTS TO BE TAKEN INTO ACCOUNT DURING THE R & D & I PHASES TO GUARANTEE ITS VALIDITY DURING THE VETERINARY MEDICINES REGISTRATION PHASE

Regulatory Requirements

This section includes a list of requirements that are demanded by authorities for the presentation of documentation of an authorisation file for both pharmacological and immunological veterinary medicines.

This set of Vetinnova includes a series of requirements that are required during the presentation of the documentation of a record of veterinary drugs, both pharmacological and immunological. These requirements do not imply an exhaustive list of all the existing ones, but a compilation of those that have been considered relevant, organizing in an easy and intuitive way for the research group.

Although Vet + i will periodically update the contents of this section, it is recommended to check the validity of these documents through the web pages of the different international, European and national institutions responsible for their edition. In addition, the National Regulatory Authority can be consulted (AEMPS)

Below is a series of links to the institutions where you can find information on the regulatory requirements in this field:

I.- International Organizations:

VICH - International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; VICH guidelines

II.- European organizations:

EDQM - The European Directorate for the Quality of Medicines & HealthCare. European Pharmacopoeia; Products and services.

EMA - European Medicines Agency. Regulatory veterinary. Scientific guidelines:

Quality guidelines:	Safety and residues guidelines:
Active substance	Pharmaceuticals
Non-immunologicals	Availability (minor uses / minor species)
Availability (minor uses minor species)	Multidisciplinary
Multidisciplinary	Biocides for use in animal husbandry

Efficacy guidelines:	Immunological guidelines:
Pharmaceuticals	General
Availability (minor uses / minor species)	Stability
Multidisciplinary	Availability (minor uses / minor species)
	Multidisciplinary

Eudralex - Normativa sobre medicamentos en la Unión Europea:

Volume 6 - Notice to applicants and regulatory guidelines for medicinal products for veterinary use.
Volume 7 - Scientific guidelines for medicinal products for veterinary use.
Volume 8 - Maximum residue limits.

New therapies.
Use of animals for drug studies.

III.- State scope Organizations:

AEMPS- Spanish Agency of Medicines and Health Products. Veterinary Medicines.
Clinical research with veterinary drugs.

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