August 2026
This regulation introduces several new provisions while at the same time revoking and consolidating several previous regulations in the healthcare sector. It places greater emphasis on domestic production, pricing transparency, the digitalization of distribution and reporting systems.
In brief
On 4 May 2026, the MOH promulgated MOH Regulation No. 5 of 2026 on Health Supplies (“MOH Regulation 5”), which comprehensively introduces several obligations that are entirely new to the Indonesian Health Supplies regulatory framework.
"Health Supplies" is defined as all materials and equipment required to support the implementation of healthcare services. They include pharmaceutical products (i.e., medicines; pharmaceutical ingredients; natural medicinal products, ingredients for natural medicinal products; cosmetics; health supplements; and quasi-drugs), household health products (Perbekalan Kesehatan Rumah Tangga/PKRT) and medical devices, as applicable.
MOH Regulation 5 repeals several prior MOH regulations, including those on marketing authorization (MOH Regulation 62/2017), import supervision (MOH Regulation 60/2017), good manufacturing practices (MOH Regulation 20/2017), and traditional medicine (MOH Regulation 6/2012).
Businesses should pay particular attention to the five-year localization deadline (which is already running), the mandatory buffer stock requirement, the six-month shortage notification obligation, the gratification prohibition and its interaction with the new price transparency regime, and the expanded sanctions framework — each of which is addressed in this alert.