1. National Identification Number (NIB)

Duration: -

2. Statement of compliance with the principles of CPOIB or a photocopy of the CPOIB certificate

Duration: -

3. 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

Duration: -

4. Quality test results for fish medicine

Duration: -

5. Field testing results for fish medicines that require field testing

Duration: -

6. 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: -

Obligations:

1. 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• The quantity and type of fish medicine withdrawn from circulation or destroyed.

Duration: -

2. Conduct specific CPOIB certification for fish medicine manufacturers.

Duration: -

3. Maintain the quality consistency of fish medicine.

Duration: -