The LEGAL PROTECTION FOR CONSUMER OF DRUG PRODUCER THAT DOES NOT HAVE A DISTRIBUTION PERMIT FROM THE FOOD AND DRUG CONTROL AGENCY (BPOM)
Main
Hendra Lazuardi*
Nur Handayati
For maintain health in carrying out daily activities, humans consume drugs as a healing solution for the ailments they experience. However, cases of illegal drug distribution threaten the health of someone who accidentally consumes illegal drugs without testing by the Food and Drug Monitoring Agency. The purpose of this research is to analyze the process of granting licenses to the distribution of drugs by BPOM and legal protection for consumers against the distribution of drugs that do not have distribution permits. This type of research is normative legal research with the Statue and Case Approach. Analysis data used descriptive qualitative analysis of existing laws and regulations to find answers to cases of drug trafficking that do not have a distribution permit. The results of the study prove that the process of granting permits for drug distribution by BPOM is carried out in two stages, namely the Pre-registration and Registration stages with the fulfillment of the required statements and documents. The evaluation process is carried out for 100 days for new drug products which is carried out by the Head of the BPOM Agency. Legal protection for consumers against the distribution of drugs that do not have a distribution permit is by imposing a maximum imprisonment of 15 years and a maximum fine of IDR 1,500,000,000.00 for the perpetrator. For producers who do not have the expertise and authority to carry out pharmaceutical practices, they will be fined a maximum of IDR. 100,000,000.00.
Anif, M. (2006). Medicine Concoction Science. Gadjah Mada UniversityPress.
Atmaja, P. M. Y. R., Astra, I. K. B., & Suwiwa, I. G. (2021). Physical Activity and Community Healthy Lifestyle as an Effort to Maintain Health during the Covid-19 Pandemic. Undiksha Journal of Sports Science, 9(2), 128–135. https://doi.org/10.23887/jiku.v9i2.31409
Benuf, K., Mahmudah, S., & Priyono, E. A. (2019). Legal Protection of Financial Technology Consumer Data Security in Indonesia. Reflections on Law: Journal of Legal Studies, 3(2), 145–160. https://doi.org/10.24246/jrh.2019.v3.i2.p145-160
Republic of Indonesia Ministry of Health. (2007). Kompendia Free Drugs Directorate of Drug and Food Control.
Republic of Indonesia Ministry of Health. (2008). Indonesian Health Profile. Indonesian Ministry of Health.
Firmansyah, B. (2020). Patients Affected by Heart Disease. Malang Muhammadiyah University.
Kasibu, S. D. G. (2017). The relationship between the level of public knowledge and the use of prescription and non-prescription drugs in the Kota Maksum II sub-district, Medan Area sub-district. North Sumatra University.
Lailiyah, A. (2019). The Level of Public Knowledge About the Use and Storage of Limited Free and Free Medicines at the Sambeng Farma Pharmacy. Muhammadiyah Gresik University.
Marzuki, P. M. (2011). Legal Research. Kencana Prenada Media Group.
Marzuki, P. Mahmud. (2014). Legal Research. Kencana Prenada Media Group.
Muchsin. (2003). Legal Protection and Certainty for Investors in Indonesia. Graphics Light.
Ocbrianto, H. (2012). Community Participation in Posyandu in Toddler Health Service Efforts (Case Study in Posyandu Nusa Indah Ii Rw 11 Meruyung Village, Limo District, Depok). University of Indonesia.
Rahardjo, S. (2006). Law Studies (6th ed.). PT Citra Aditya Bakti.
Samosir, F. (2021). Juridical Review of the Responsibilities of Drug Traffickers Without a Permit (Case Study of the Decision of the Supreme Court of the Republic of Indonesia Number 1570 K/Pid.Sus/2020). Journal of Law and Society Al-Hikmah, 2(4), 750–771.
Sarwono, J. (2006). Quantitative and Qualitative Research Methods. Science House.
Suardita, I. K. (2017). Introduction to Legal Materials (PBH). Simdos. Unud. Ac. Id, 3.
Supriadi. (2001). Indonesian Medicinal Plants: Their Uses and Efficacy. Indonesian Torch Foundation.
Supriyadi, S. (2017). Community of Practitioners: Alternative Knowledge Sharing Solutions between Librarians. Lentera Pustaka: Journal of Library Studies, Information and Archives, 2(2), 83. https://doi.org/10.14710/lenpust.v2i2.13476
Wahyudi, A. R. (2020). Literature Study: An Overview of Pharmacists' Understanding, Experience, Expectations About Clinical Pharmacy Services at Pharmacies. Banjarmasin Muhammadiyah University.
