1. What procedures should I follow to register a feed or veterinary drug in Belize?
- A formal request to the Registrar, Central Investigation Laboratory, BAHA in Belize City for the registration of veterinary product with the following information will need to be submitted:
- The trade name of the veterinary drug, veterinary pesticide or biological.
- Details of the labels of the veterinary product, including two copies of the labels for approval by the Unit.
- List of ingredients in the formula.
- Use indications and target species.
- Withdrawal period in food producing animals
- Country of manufacture or origin and the name of manufacturer
- Analytical methods for quality control.
- A copy of the License of the Manufacturing Establishment issued by the competent authority of the country of origin.
- A copy of the Veterinary Product License or Registration Certificate or marketing authorization issued by the competent authority of the country of origin.
- An original Certificate of Free Sale or an original Export Certificate issued by the Competent Authority of the country of origin and certifying that:
- The facility or establishment where the product is manufactured is regulated by the Competent Authority and complies with the regulatory requirements and standards regarding production and quality assurance of the veterinary drugs, biologicals, pesticides listed in this certificate.
- The Competent Authority on a regular basis inspects the facility or establishment where the product is manufactured.
- The product listed in this certificate is currently licensed in the country of origin for distribution and sale and or for export to foreign countries.
- The product meets the regulatory requirements regarding purity, safety (copy of the material safety data sheet), efficacy, and potency (for vaccines).
- All materials of animal origin (vaccines) used in the preparation of this product have been originated from sources considered to be safe from BSE contamination.
- A copy of Certificate of Analysis showing the results of the required tests of the final product.
- An original “Declaration of Compliance” printed on the company letterhead and signed by an authorized person of the manufacturer confirming that all materials of animal origin used in the preparation of this product have originated from sources considered to be safe from Bovine Spongiform Encephalopathy (BSE) infection or contamination.
- For Biotechnology-derived product, a copy of RISK ANALYSIS confirming that the product is safe for target and non-target animal species, humans and the environment.
2. Is there a fee for the registration process?
- A fee of one hundred and fifty ($150.00 BZE) dollars apply for registering a Veterinary Vaccine and or an Animal Feed.
- The cost for registering a Veterinary Drug/Veterinary Pesticide is one hundred ($100.00) BZE dollars.
3. For what period is this registration valid?
- The registration of a veterinary product is valid for 5 yrs.