PERLINDUNGAN HUKUM BAGI KONSUMEN OBAT PALSU YANG BEREDAR DI PASARAN WILAYAH DAERAH ISTIMEWA YOGYAKARTA

The enactment of Undang-undang No. 36 Tahun 2009 (UUK) is the legal basis for drug consumers. The existence of the UUK can be expected that people taking the qualified drugs. Additionally, there is Undang-undang No. 8 Tahun 1999 which regulates the rights of consumers. The role of the Indonesian gov...

Full description

Saved in:
Bibliographic Details
Main Authors: , Ritanada Murniati, SH, , Prof. Dr. Nindyo Pramono, S.H., M.S.
Format: Theses and Dissertations NonPeerReviewed
Published: [Yogyakarta] : Universitas Gadjah Mada 2014
Subjects:
ETD
Online Access:https://repository.ugm.ac.id/134161/
http://etd.ugm.ac.id/index.php?mod=penelitian_detail&sub=PenelitianDetail&act=view&typ=html&buku_id=75177
Tags: Add Tag
No Tags, Be the first to tag this record!
Institution: Universitas Gadjah Mada
Description
Summary:The enactment of Undang-undang No. 36 Tahun 2009 (UUK) is the legal basis for drug consumers. The existence of the UUK can be expected that people taking the qualified drugs. Additionally, there is Undang-undang No. 8 Tahun 1999 which regulates the rights of consumers. The role of the Indonesian government through the BPOM is expected to make efforts on controlling the distribution and the usage of drugs that can ensure that people administrating the qualified drugs. This study aimed to determine the implementation of the legal protection of consumer by BPOM through the production and distribution process of drugs as well as supervision and efforts to prevent the marketing of counterfeit drugs in Daerah Istimewa Yogyakarta. This study was juridical normative and empirical literature with a combination of literature and field research. The data was taken from the facts, related documents and legislation. Data collection was done by field researching, interviewing and literature studying based on obtained research data directly at BBPOM Yogyakarta and Lembaga Konsumen Yogyakarta. The legal protection of counterfeit drugs has been accommodated by the UUPK. Besides UUPK, Undang-undang Kesehatan also plays a role in protecting consumers of counterfeit drugs. This legal protection process was conducted by the BPOM which is started with the licensing process on drugs at the registration to post marketing process through the surveillance phase of drug registration, consumer information, and the stage of examination and investigation. Periodic determination of active substances through cooperation with related laboratory needed to ensure that consumers get qualified drugs. In addition, supervision is also necessary, especially unprescribed drugs in ilegal distribution fasilities as a source of the circulation of counterfeit drugs and is followed up with appropriate legal action. Keywords : Legal Protection, Counterfeit Drugs, The Role of BPOM, DIY