regulation of the head of nadfc ri no. hk.03.1.3.12.11.10692 of 2011 concerning the importation control of pharmaceutical products 9 nine pages in bahasa indonesia this regulation replaces regulation of the head of nadfc ri no. hk.00.05.1.3459 of 2005 concerning the importation control of pharmaceutical products. importation of pharmaceutical products can only be done by the pharmaceutical industries which hold marketing authorization from the head of nadfc hold marketing authorization from the head of nadfc. in the implementation the pharmaceutical industry which has marketing authorization may appoint another pharmaceutical industry or importers pharmaceutical wholesalers as the executor of pharmaceutical product importation. beside comply with the applicable provisions of importation the importation of pharmaceutical products also must be approved by the head of nadfc ri in the form of the certificate of importation ski which is only valid for every single importation. ski applied electronically through the nadfcs website www.pom.go.id or through the nsw of nadfc e-bpom.pom.go.id . each application has been charged to expense in accordance with the government regulation of republic of indonesia no. 48 year 2010 on non-tax revenues which prevails in nadfc. ski is given at the latest 1 one working day after all requirements complete and correct. ski application must be atttached with the following documents a.marketing authorization of imported pharmaceutical products bulk products b.certificate of analysis coa issued by manufacturer for each batch lot specifically in coa of sera for human use should be declared the source of active ingredients c.letter of appointment if the import done by the executor appointed by the marketing authorization holder d.invoices e.proof of payment of state revenue non-tax revenues and f.bill of lading b l or air way bill awb . importation of vaccines for human use should also be completed with the following documents a.batch lot release certificate issued by the authority agency of a releasing country for every single importation and b.summary batch lot protocol issued by the manufacturer. importation of vaccines which has obtained the certificate of importation from nadfc can only be distributed after nadfc conducting sampling evaluation and testing of imported vaccines. the result should meet the requirements and the entire cost is the responsibility of the applicant. all documents related to importation of drug must be documented in accordance with the guidelines of good distribution practices.