PROCEDURES FOR IMPORTA-TION OF MEDICAMENTS AND MEDICATED COSMETICS UNDER AUTHORIZATION

05/01/2003

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In response to the automation of customs clear-ance procedures, and in order to reduce the dif-ficulty of judgment and errors by Customs when reviewing authorization documents, on 28 No-vember 2002, the Department of Health (the DOH), Executive Yuan, announced the follow-ing reporting procedures and requirements ap-plicable when the holder of an import license for a medicament or medicated cosmetics authorizes another entity to import such product pursuant to Article 39 of the Law Governing Pharmaceutical Affairs, Articles 7 and 8 of the Law Governing Cosmetics Hygiene, and Article 4 of the En-forcement Rules of the Law Governing Cos-metics Hygiene.

When the holder of an import license for a medicament or medicated cosmetics author-izes another entity to import the product, it must apply for approval with the DOH by submitting an application for recordation of authorized importation, on which it must state the product license number, the pharmaceuti-cals firm license number, the company or factory name and the business registration certificate number of the authorized company, as well as the date of authorization. A pho-tocopy of each of the above documents must also be appended. Upon approval, the DOH will issue an approval document number, which can then be used for importation cus-toms clearance. The same procedure applies to short-term authorizations, sin-gle-consignment authorizations, and termina-tions of or amendments to authorizations.

In the case of the importation of controlled drugs, the license holder must also apply with the DOH's National Bureau of Controlled Drugs for each consignment for a consent document, submitting information relating to the import authorization. The consent docu-ment number is then used in place of the ap-proval document number to complete customs clearance in accordance with the relevant provisions of the Statute Governing the Management of Controlled Drugs.