Fish Medicine Registration Certificate
UMKU Detail
Parameter: All
Authority: Minister/Head of Agency
- National Identification Number (NIB)
- Statement of compliance with the principles of CPOIB or a photocopy of the CPOIB certificate
- Technical data for Fish Medicine, including:
- Form A (Composition of Fish Medicine)
- Form B (Manufacturing of Fish Medicine)
- Form C (Examination of Fish Medicine)
- Form D (Examination of Raw Materials for Fish Medicine)
- Form E (Stability Examination)
- Form F (Pharmacological Power)
- Form G (Scientific Publication/Field Testing)
- Form H (Information on Packaging and Labels)
- Form I (Information on Labeling)
- Form J (Other Information for Fish Medicines from Abroad) including:
- Certificate of Origin
- Certificate of Free Sale
- Certificate of Good Manufacturing Practice (GMP)
- Certificate Non-Genetically Modified Organism for biologic fish medicines that are not genetically modified products
- Letter of Appointment from foreign fish medicine manufacturer to the fish medicine importer in Indonesia
- Quality test results for fish medicine
- Field testing results for fish medicines that require field testing
- Photocopy of the biotechnology product safety certificate from the Biosafety Commission for fish medicines with active ingredients or one of the active ingredients being genetically modified organisms (GMO)
Duration: -
Duration: -
Duration: -
Duration: -
Duration: -
Duration: -
Obligations:
- Submit written reports including:
- The quantity and type of fish medicine produced and distributed, for the domestic production of fish medicine;
- The quantity and type of fish medicine distributed, for the importation of fish medicine from abroad;
- The quantity and type of fish medicine withdrawn from circulation or destroyed.
- Conduct specific CPOIB certification for fish medicine manufacturers.
- Maintain the quality consistency of fish medicine.
Duration: -
Duration: -
Duration: -
Sector: Marine and Fisheries
Status: Available
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