Implementation Of Article 2 Paragraph (1) Of The Minister Of Health Regulation Number 7 Of 2012 Concerning The Registration Of Traditional Medicines Relating To The Distribution Of Traditional Medicines Without A Distribution Permit In Buleleng Regency

Abstract

The aim of this research is to find out and analyze the implementation of Article 2 paragraph (1) of Minister of Health Regulation Number 7 of 2012 concerning Registration of Traditional Medicines Regarding the Distribution of Traditional Medicines Without a Marketing Permit and to find out how to enforce the law against business actors whose traditional medicine products do not have a distribution permit. . The type of research used is empirical legal research with descriptive research characteristics. The location of this research was carried out in Buleleng Regency. Technical data collection was used by means of literature study, observation and interviews. The sampling technique used was the Non-Probability Sampling Technique and the subject determination used Purposive Sampling. Qualitative data processing and analysis techniques. The research results show that the provisions of Article 2 paragraph (1) of Minister of Health Regulation Number 7 of 2012 concerning Traditional Medicine Registration which regulates distribution permits for traditional medicines have not been implemented properly. This is reflected in the fact that there are still business actors who do not process distribution permits in accordance with applicable regulations. Meanwhile, law enforcement against business actors takes the form of administrative sanctions as regulated in Article 23 of the Minister of Health Regulation Number 7 of 2012 concerning Registration of Traditional Medicines. There are administrative sanctions in the form of summons, coaching and warnings against traditional medicine businesses without distribution permits. And law enforcement through Law Number 17 of 2023 concerning Health Article 435 related to criminal sanctions and fines.