New Regulation for the Distribution of Health Utilities Products

A new regulation on the distribution of health utilities products has recently been issued in the form of Minister of Health Regulation No. 1191/MENKES/PER/VIII/2010 (“Regulation”). In essence, the Regulation sets out more thorough distribution guidelines and new obligations for distributors of health utilities products compared to the previous Minister of Health Regulation No.1184/MenKes/Per/X/2004 on Safety Measures of Health Utilities Products and Household Health Utilities, which it replaces.    

The health utilities products, the distribution of which falls under the Regulation, are machines and/or implants whose purpose it is to diagnose, prevent, cure, and reduce pain and diseases. Further, the machines and/or implants are classified into two categories: those that do not contain medication and those that contain medication but its function is only to support the purpose of the health products through the process of pharmacology, immunology, or metabolism. For such products to be distributed they have to comply with the Indonesian Pharmacopoeia Standard, the Indonesian National Standard (SNI), and other standards set by the Director General of Pharmacy and Health Utilities at the Ministry of Health.

It is not only local health utilities producers and large pharmacies who are obliged to obtain a distribution license, but also health utilities product distributors who fall into the categories of being the main distributor, branch distributor, and health utilities store, including pharmacies and retail stores, and consequently also have to acquire a distribution license. The Regulation gives the distributors a grace period of 6 months, under Article 13, to obtain a distribution license, which is shorter than that of Regulation No.1184/MenKes/Per/X/2004, which allowed for 8 months. Importers and exporters, in acquiring a distribution license, also have to acquire a certificate of exportation and a certificate of free sale.    

The legal requirements that an applicant must meet in order to acquire a license, in addition to complying with the Comprehensive Distribution Method (Cara Distribusi Alat Kesehatan yang Baik / CDAKB), is that the applicant must be a legal entity with a full time technician and has a sufficient office building and a warehouse. Failing to satisfy these requirements will result in an application being rejected.   

In order to ensure the safety of health utilities products, the license holder is obliged to periodically sample their distributed products and report their observations to the Directorate Genera of the Ministry of Health. In the event that the health utilities products are found to be harmful to consumers the products will be recalled and destroyed in accordance with Articles 43, 47 to 51.     

Distribution licenses issued prior to the Regulation are valid until the date of expiration, and licenses without a date of expiration are valid for 3 years after the issuance of the Regulation.

The Regulation has been in force since 23 August 2010.