
In order to supervise and monitor Precursors --a substance that becomes an intrinsic part of a product chemical following a reaction-- The Head of the Drug and Food Supervisory Authority (“BPOM”) recently issued Decision stipulating terms and conditions with regard to Precursors’ production, export and import.
Decision No: HK.00.05.35.02771 on the Monitoring and Supervision of Precursors (the “Decision”) consisted of 13 articles and an attachment enumerating types of Precursors, which are divided into two groups.
Article 1 of the Decision stipulates that monitoring and supervision are conducted toward all types of precursors. It further regulates that such supervision and monitoring will be conducted through a letter import approval for every importation commenced and letter of export approval for every export commenced, including pre-export notification from the country of origin of the relevant precursors, and compulsory reporting of the management methods with respect to precursors. BPOM is responsible for the monitoring and supervision of the precursors listed in Group 1 and other related institutions will be responsible for those precursors listed in Group 2. Import of Precursors substances may only be conducted by importers having import permit.
It is expressly stated that companies in the pharmaceutical or chemical industry may only import precursors to satisfy their own production needs. This would prevent secondary market for precursors from developing in
Pharmaceutical or chemical industry using precursors shall appoint a technical officer as a person in charge of precursors’ production. Importer or exporter of precursors shall also appoint a technical officer in charge of either importation or exportation of the substance.
Article 6 of the Decision provides more stringent control for Precursors listed as Group I of the decision’s attachment, as it requires importer and exporter to apply for Export Approval Letter to BPOM every time an import or export is to be commenced, including submitting a report within at least 7 days after the importation or exportation take place.
BPOM may inspect, take samples, check records, and evaluate companies in the pharmaceutical and chemical industries. Where breaches of the provisions are identified, BPOM is authorized to issue verbal warnings, written warnings, temporary suspension of activities, and the cancellation of any licenses issued.
This Decision revokes earlier Decision number HK: 00.06.6.03181 on the Monitoring of Psychotropic Precursors (mma)
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