1. Data Requirements for Old Products/Generics, Bioequivalence
Data Requirements for Old Products/Generics, Bioequivalence. A Perspective from Argentina
6th VICH Outreach Forum
MV Carlos FRANCIA
CAPROVE – Cámara Argentina de Productos Veterinarios

2. Introduction How is a product registered in almost all CAMEVET?
The veterinary medicines register system is based on the «new product» concept. Every product, innovative or not, are under the same kind of requirements.
To register a “new product”, the owner has to submit a complete application form.

3. Introduction

4. Application form
The application form is a detailed list of requirements that must be fulfilled.
It has four parts
Administrative data
Quality
Efficacy
Safety

5. Innovative vs. Old products
Innovative products
New API
New API combination
New formulation with different PK
“Old products”
Old and well known API (or API combination)
Well known formulations

6. All products Administrative data includes (imported products)
FSC
Establishment license
GMP certificate
Quality data must be referred to the proposed product.

7. Old Products Requirements
Efficacy and Safety
The information needed can be obtained from technical published works
If the product is included in national erradication programs (like mange or bovine ticks), local efficacy and safety tests could be mandatory. Some of these tests are performed by the regulatory authorities

8. Bioequivalence Proposed uses Under discussion
Significant changes in formulation (excipients or process) that could affect bioavailability
New administration route for a registered product
Under discussion
Avoid efficacy or safety trials in products that are pharmaceutical equivalents

9. Bioequivalence Residue trials?
If the bioequivalence study covers all the time required for depletion (withdrawal), bioequivalence could be a useful tool to avoid unnecessary trials that require animal’s death.

10. Thanks a lot!