Approval Letter for Changes to Drug Marketing Authorization
-
Micro, Small, and Medium Enterprises (UMKU) Details
Parameter: All
Authority: Minister/Head of the Agency
Requirements:- Standards and criteria for drug registration Duration: -
- Indonesian Pharmacopoeia standards and/or analysis methods, standards, and/or other requirements Duration: -
-
Obligations:
- Ensure the safety, efficacy, quality, and labeling of drugs during the marketing authorization validity period Duration: -
- Implement Registration Variation Approvals Duration: -
- Report the quantity, batch numbers, and expiration dates of the last distributed batches to the Non-Ministerial Government Institution responsible for drug and food supervision Duration: -
Sector: Drugs and Food
Status: Available
Belongs to:
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Due to frequent changes in regulations and government policies, there is a prevalence of misleading and outdated advice.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.