Animal Drug Registration Permit (approval for changing the registration number of animal drugs)

UMKU Pharmaceutical Industry Details

Parameter: All

Authority: Minister/Head of Agency

Requirements:

  1. Change in composition, factory location, production process, shelf life, administration route, target animals, and/or packaging materials

    • Approval from the Head of the Center for Veterinary Medicinal Products (PPOH) for technical documents (dossier) of veterinary drugs
    • Letter of registration number for veterinary drugs
    • Certificate of quality testing results from the National Quality Testing and Certification Center for Veterinary Drugs (BBPMSOH)

  2. Changes in indications and/or withdrawal times of the drug

    • Approval from the Head of the Center for Veterinary Medicinal Products (PPOH) for technical documents (dossier) of veterinary drugs
    • Letter of registration number for veterinary drugs

  3. Changes in product name, factory name, container/packaging size, and/or packaging volume

    • Approval for technical documents (dossier) of veterinary drugs
    • Letter of registration number for veterinary drugs

  4. Changes in label/label design

    • Letter of registration number for veterinary drugs
    • Justification for the label/label design changes

Obligations

Sector: Agriculture
Status: Available
Belongs to:
20233
21013
21014
21023
21024
46444
46445
46446
46447
46448
46692

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