Penelitian ini bertujuan guna menjawab pertanyaan terkait Tanggung Jawab Perdata Pelaku Usaha Terkait Peredaran Obat Tradisional Berbahan Kimia Obat. Pertama, bagaimana prosedur yang wajib dipatuhi pelaku usaha dalam memproduksi obat tradisional? Kedua, bagaimana pertanggungjawaban perdata pelaku usaha kepada konsumen akibat peredaran obat tradisonal berbahan kimia obat?. Metode penelitian yang digunakan dalam penelitian yaitu tipe penelitian yuridis normatif, dengan pendekatan perundang-undangan (statute approach) dan pendekatan konseptual (conceptual approach). Data yang digunakan terdiri dari data sekunder, data primer dan data tersier. Hasil dari penelitian, penulis menyimpulkan bahwa: pertama, prosedur pelaku usaha dalam pembuatan obat tradisional wajib menerapkan aspek Cara Pembuatan Obat Tradisional yang Baik (CPOTB). Penerapan Cara Pembuatan Obat Tradisional yang Baik (CPOTB) merupakan persyaratan kelayakan dasar untuk menerapkan sistem jaminan mutu dan keamanan yang dipersyaratkan dalam seluruh rangkaian kegiatannya, hal tersebut mengacu pada Peraturan Menteri Kesehatan Nomor 6 Tahun 2012 Tentang Industri dan Usaha Obat Tradisional Pasal 35. Kedua, pertanggungjawaban perdata pelaku usaha terhadap konsumen terkait peredaran obat tradisonal berbahan kimia obat bahwa pelaku usaha akan bertanggungjawab mengganti kerugian apabila dapat dibuktian kerugian yang terjadi itu akibat dari kesalahan pelaku usaha.

Kata Kunci: Perlindungan Konsumen, Prosedur, Pelaku usaha, Obat Tradisional, Sengketa

The purpose of the research was to answer questions related to the civil liability of business actors involved in the distribution of traditional medicines made with medicinal chemicals. First, what are the procedures to be followed by business actors in the production of traditional medicines? Second, how is the civil liability of business actors to consumers due to the distribution of traditional medicines made of medicinal chemicals? The research method used is normative legal research type, with a statute approach and conceptual approach. The data used consists of secondary data, primary data and tertiary data. The results of the research show that: first, the procedure for business actors in the production of traditional medicines must apply aspects of the good traditional medicine manufacturing method. The application of the good traditional medicine manufacturing method is a basic eligibility requirement for the implementation of the required quality and safety assurance system in all series of activities, this refers to the Regulation of the Minister of Health Number 6 of 2012 concerning the Traditional Medicine Industry and Business Article 35. Secondly, the civil liability of business actors to consumers in relation to the distribution of traditional medicines made from medicinal chemicals, that the business actors will be responsible for compensating losses if it can be proven that the losses incurred are due to the fault of the business actors. Keywords: Traditional Medicine, Consumer Protection, Business Actor, Procedure, Responsibility