Regulations for Registration of Medicinal Products｜第 7 條｜Food and Drug Administration｜Regulation｜In Force
第 二 章/第 一 節｜衛生福利部｜v1.0
Effective Date: 2024-01-01｜Last Amended: 2023-04-27
Except as otherwise regulated in the Regulations, the CPP said in this Chapter should be issued by the highest health competent authority of the issuance country and authenticated of any one of the A10 countries or the EMA. CPP can be replaced with the following documents: 1.The package insert approved by the reference country or a photocopy of the reference country’s pharmacopoeia (as listed below, as “official formulary”); printouts from the Internet or the electronic version are also acceptable. It does not have to be issued by the highest health competent authority of the reference country, nor be authenticated by the R.O.C. foreign affairs offices. The edition of the cited official formulary should be indicated, and has to be published within 5 years from the citation. (1) US: Physicians’ Desk Reference (PDR); (2) UK: British National Formulary (B.N.F.), Medicines Compendium (published by Association of British Pharmaceutical Industries, ABPI); (3) Japan: Drugs in Japan, the most recent new drugs in Japan; (4) Switzerland: Arzneimittel-Kompendium der Schweiz; (5) Canada: Compendium of Pharmaceuticals and Specialties; (6) France: Dictionnaire VIDAL; (7) Australia: MIM’S; (8) Germany: Rote Liste; (9) Belgium: Repertoire Commente des Medicaments; (10) Sweden: Farmaceutiska Specialiteter i Sverige (FASS); 2.The approval letter and the approval information on the website of the highest health competent authority of any one of the A10 countries or the EMA.