Vet + i 

Reference Portal on R + D + i in animal health 

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An initiative of Vet + i 

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  • Regulatory requirements

Regulatory requirements

REGULATORY REQUIREMENTS TO BE CONSIDERED DURING R&D&i  PHASES TO ENSURE THEIR VALID DURING THE VETERINARY DRUG REGISTRATION

 

Although from Vet + i will proceed to the regular updating of the contents of this section , it is recommended to check the validity of these documents through the website of the various international institutions , European and national responsible for editing. You can also consult the national regulatory authority (AEMPS)

Then it is a series of links to the institutions in which they 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 Wide Organisations:
 
EDQM - The European Directorate for the Quality of Medicines & HealthCare. European Pharmacopoeia; Products and services.  

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

 
 
 
Eudralex - Rules Governing Medicinal Products in the European Union:
  • 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.
 
III. - State scope Organizations:
 
AEMPS- Agencia Española de Medicamentos y Productos Sanitarios. Medicamentos veterinarios.