Drug Distribution Permit
- UMKU PB (Small and Medium Enterprises Requirements) Details
- Parameter: All
- Authority: Minister/Head of Agency
- Requirements
- 1. Proof of PNBP (Non-Tax State Revenue) payment
- Duration: -
- 2. Equivalence testing guidelines
- Duration: -
- 3. Standards and Requirements for drug registration criteria and procedures; and
- Duration: -
- 4. Indonesian Pharmacopoeia and/or analytical methods, standards, and/or other reference standards.
- Duration: -
- Obligations
- 1. Ensure the safety, efficacy, quality, and labeling of drugs.
- Duration: -
- 2. Complete registration documents.
- Duration: -
- 3. Ensure the safety, efficacy, quality, and labeling of drugs and perform pharmacovigilance monitoring and reporting of drug side effects to the head of the agency responsible for drug and food supervision, following pharmacovigilance implementation standards while the marketing authorization is valid.
- Duration: -
- 4. Produce or import drugs.
- Duration: -
- 5. Be responsible for the quality and labeling of drugs during the validity of the Marketing Authorization.
- Duration: -
- 6. Conduct further clinical studies/trials on drugs that are in clinical trials worldwide to ensure their effectiveness and safety.
- Duration: -
- 7. Conduct pharmacovigilance monitoring and report drug side effects to the head of the agency responsible for drug and food supervision.
- Duration: -
- 8. Report the realization of import, production, and distribution of drugs during emergency use authorization to the head of the agency responsible for drug and food supervision.
- Duration: -
- 9. Implement Registration Variation Approvals.
- Duration: -
- 10. Report the quantity, batch numbers, and expiration dates of the last distributed batches to Non-Ministerial Government Agencies responsible for drug and food supervision.
- Duration: -
- 11. Ensure the safety, efficacy, quality, and labeling of drugs while the Marketing Authorization is valid.
- Duration: -
- 12. Implement changes through the change control mechanism.
- Duration: -
- 13. Report the implementation of variations to Non-Ministerial Government Agencies responsible for drug and food supervision.
- Duration: -
Sector: Drugs and Food
Status: Available
Belongs to:
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