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NEW REGULATIONS ON PHARMACEUTICALS IMPORTS


Edward H. H. Liu

To regulate the registration, customs clearance, and port-of-entry inspection of pharmaceuticals imports, on 18 August 2003 the PRC's State Food and Drug Administration (SFDA) and General Administration of Customs promulgated the Administrative Measures on the Import of Pharmaceuticals, which will take effect on 1 January 2004, on which date the current Regu-lations Governing Imported Drugs, in force since 1 May 1999, will be repealed.

Under the new measures, registration and port-of-entry inspection procedures for imported pharmaceutical products may not be conducted until an "import drugs registration certificate" or "import drugs approval notice" has been issued by the SFDA. In the case of narcotic or psy-chopharmacological drugs, the corresponding "import approval certificate" must also be ob-tained from the SFDA. Applications for import registration should be made to the food and drug administration at the port of entry, and inspec-tions will be carried out by the port of entry's drugs inspection station.
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