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Asian Investment Desk
Banking and Finance
Banking Regulation
Capital Markets
Corporate and Commercial
Corporate Compliance
Energy
Environmental
ESG | Environmental, Social and Governance
Fintech
Fishery
Forestry
Immigration
Infrastructure and Concessions
Insurance and Reinsurance
Intellectual Property
International Trade and Customs
Labor & Employment
Life Sciences
Maritime and Aviation
Mergers and Acquisitions
Mining
Oil & Gas
Privacy and Data Protection
Project Development
Project Finance
Public Law
Public Procurement
Public Services Regulation
Real Estate Investment
Restructuring and Insolvency
Tax
Telecom, Media & Technology (TMT)
Venture Capital and Entrepreneurship
Water Resources and Sanitation
Wealth Management
Alert
Life Sciences Alert - August 2024
For more information, contact:
Themes
August 27, 2024
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