In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Rohipnol Drug Master File in Korea (Rohipnol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rohipnol. The MFDS reviews the Rohipnol KDMF as part of the drug registration process and uses the information provided in the Rohipnol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rohipnol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Rohipnol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rohipnol suppliers with KDMF on PharmaCompass.