ALERT – LIFE SCIENCES
Veterinary products and animal feedstuffs – New draft regulation
We refer to the latest regulatory developments related to the regulation of veterinary products and animal feed.
SENASA recently published on its web page the draft amendment to the Regulation of veterinary products and animal feed (Supreme Decree N°. 015-98-AG).
The draft proposes the modification and inclusion of the following topics:
- Duration of registration: 10 years renewable
- Stability study: New requirement in the application for registration of animal feed.
- Veterinary pharmacovigilance: Pharmacovigilance activities are detailed for the veterinarian, the responsible holders or companies and for SENASA.
- Stock report: The obligation is semi-annual.
- Procedures for changes: Changes and requirements for product registration, importer, exporter, distributor, manufacturer and retailer are specified.
- Establishment facilities: Areas or facilities must be declared physically separate from buildings used for housing or other unrelated purposes.
- Suspension and cancellation of registration: There are 15 grounds for suspension and cancellation of product, importer, exporter, distributor, manufacturer and retailer registration.
- GMP: Implementation of Good Manufacturing Practices (GMP) of domestic and foreign manufacturers.
- Stock depletion.
- Active ingredients: Import authorization.
- Products observed: Final disposal.
- Violations and penalties: Fines from 02 UIT to 20 UIT, confiscation of products and temporary closure of the establishment.
For the above reasons:
- The proposal includes an adequacy period of 5 years, counted from the entry into force of the regulation.
- Comments and observations to the draft regulations may be submitted until September 12, 2024.
- Changes will have to be implemented in the current registries.
- See draft at the following link: Draft regulations on veterinary products
For further information, please contact Maritza Reátegui (mreategui@estudiorodrigo.com) and Solange Noriega (snoriega@estudiorodrigo.com).
