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Print articleNew Criteria And Procedure For Drug Registration in Indonesia
January, 2012 -
In order to provide extensive protection, especially for the distribution of drugs in Indonesia, BPOM has issued a new regulation which sets out the criteria and procedure for drug registration, ie BPOM Regulation No. HK.03.1.23.10.11.08481 of 2011 regarding The Criteria and Procedure For Drug Registration. Under this BPOM regulation, a distribution permit is required to distribute drugs within Indonesian territory and to obtain a distribution permit, the relevant drugs must first be registered.
Registration is in two phases, preregistration and registration for which different forms are used. Pre-registration is required, for among other reasons, to determine the registration category, the evaluation method and evaluation costs, and the documents required for the drug’s registration.
Imported drugs can now only be registered by an applicant who has obtained prior approval from the foreign pharmaceuticals producer.
An evaluation phase follows submission of the registration documents. There are two types of evaluation, a 40 day procedure and a 100 day procedure. The type of evaluation will be determined by the type of drug to be registered.
Approval for registration is issued as approval for:
Registration is in two phases, preregistration and registration for which different forms are used. Pre-registration is required, for among other reasons, to determine the registration category, the evaluation method and evaluation costs, and the documents required for the drug’s registration.
Imported drugs can now only be registered by an applicant who has obtained prior approval from the foreign pharmaceuticals producer.
An evaluation phase follows submission of the registration documents. There are two types of evaluation, a 40 day procedure and a 100 day procedure. The type of evaluation will be determined by the type of drug to be registered.
Approval for registration is issued as approval for:
- a distribution permit (persetujuan izin edar);
- importing in bulk (persetujuan impor dalam bentuk ruahan);
- importing drugs for export (persetujuan impor untuk ekspor); and
- specifically exporting drugs (persetujuan khusus ekspor).
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