UMKU Details

Parameter: -

Authority: -

Requirements and Obligations:

1. 1. Criteria and Procedures Standard for Quasi Drug Registration;

   Duration: -

2. 2. Standard Requirements for Safety and Quality of Quasi Drugs;

   Duration: -

3. 3. Compendial standards that can be used as references: Indonesian Pharmacopoeia/Herbal Pharmacopoeia, Compendial/International Standards, and/or other analytical method reference;

   Duration: -

4. 4. Standard and Requirements for drug registration criteria and procedures;

   Duration: -

5. 5. Indonesian Pharmacopoeia and/or analytical methods, standards, and/or other requirements;

   Duration: -

Obligations:

1. 1. Complete registration documents.

   Duration: -

2. 2. Ensure the safety, efficacy, quality, and labeling of the drug, and conduct pharmacovigilance monitoring and reporting of drug adverse effects to the head of the institution responsible for drug and food supervision, in accordance with the pharmacovigilance implementation standards during the validity of the marketing authorization.

   Duration: -

3. 3. Manufacture or import drugs.

   Duration: -