Legal Certainty In Post-Issuance Supervision Of Pharmacy License In Risk-Based Business Licensing For Pharmacies In Balikpapan City

Abstrak

The implementation of risk-based business licensing through the Online Single Submission Risk-Based Approach (OSS-RBA) has transformed pharmacy licensing and supervision, making legal certainty dependent not only on license issuance but also on the consistency of post-licensing supervision. This study aims to analyze the construction of legal certainty in post-issuance supervision of Pharmacy Licenses (Surat Izin Apotek/SIA) and identify the regulatory, institutional, and implementation factors affecting it in Balikpapan City. This study employed a qualitative approach with a case study design. Data were collected through in-depth interviews with six purposively selected informants representing the Balikpapan City Health Office, the Investment and One-Stop Integrated Services Office, and pharmacy business actors, supplemented by observation and document analysis. Data credibility was ensured through source triangulation and member checking, while the data were analyzed interpretively. The findings demonstrate that legal certainty in post-issue supervision is constructed through the interaction of regulatory clarity, institutional authority, consistency of supervisory procedures, actors' understanding, and business actors' experiences. However, its implementation remains suboptimal due to incomplete inter-agency coordination and supervisory system integration, limited supervisory resources, and uneven understanding among business actors regarding post-licensing obligations. The study concludes that stronger local regulations, institutional coordination, system integration, regulatory dissemination, and standardized supervisory procedures are required to establish consistent and implementable legal certainty.