Approval for the Use of Drug Manufacturing Facilities.
UMKU PB Details
Parameter: All
Authority: Minister/Head of the Agency
Requirements
- Standards and Requirements for Good Manufacturing Practice Certification
- Good Manufacturing Practice Standards based on examination by the agency responsible for government affairs in the field of drugs and food control
- Requirements for Good Manufacturing Practice Certification
- Good Manufacturing Practice Standards
Duration: -
Duration: -
Duration: -
Duration: -
Responsibilities
- Comply with Good Manufacturing Practice Standards during production activities
- Report production activities to the head of the agency responsible for government affairs in the field of drugs and food control, including:
- Reports on the import and use of Active Pharmaceutical Ingredients (API), drug production and distribution, API production and distribution, export and import of drugs and API;
- Reports on the import and use of API, drug production and distribution, API production and distribution, for Narcotics, Psychotropics, Pharmaceutical Precursors, and Specific Drugs;
- Reports on the realization of drug and API exports and imports for Narcotics;
- Reports on the realization of drug and API exports and imports for Psychotropics and/or Pharmaceutical Precursors;
- Pharmaceutical Industry master data reports containing information/profiles of the pharmaceutical industry, including production activities and production equipment used.
- Report the master documents of the pharmaceutical industry
Duration: -
Duration: -
Duration: -
Sector: Drugs and Food.
Status: Available
Need advice on setting up a company in Indonesia?
KBLI.co.id is a subsidiary of Emerhub, the largest independet corporate advisory firm in Indonesia.
![](/img/assistance.png)
Schedule a free consultation
Share your plans for Indonesia with us, and our advisors will recommend the most appropriate type and classification of legal entity for your needs.
![](/img/options.png)
No commitment required
We recognize that you might be in the exploratory phase of deciding whether and how to expand into Indonesia. Allow us to simplify this process for you.
![](/img/qualified.png)
Always credible information
Due to frequent changes in regulations and government policies, there is a prevalence of misleading and outdated advice. As we handle company registrations daily, we are well-informed about the most current information.