Application for registration

(1) An application for registration of a drug shall be made in the form set out as Form 1 in Schedule I, and shall be accompanied by the followingForm 1. Schedule I. (a) a valid GMP certificate; (b) a valid certificate of Pharmaceutical Product (CPP) based on the model established by World Health Organisation or a Certificate of Free Sales (CFS) if the country of origin is not a member of the World Health Organisation certification scheme; (c) a valid certificate from the competent health authority in the country of origin; Food and Drugs 135 (d) a valid certificate of analysis of finished drug submitted by the manufacturer’s quality control lab, original; (e) the drug’s technical information, namely– (i) a summary of product characteristics, including information in support of its contents; and (ii) samples of the final marketing package, which should include the labels, primary packaging, secondary packaging and any external packaging for all dosage forms and presentations of the medicine to be marketed, the package accessories if applicable, and samples of the finished (f) pharmacological information of finished drug; (g) environmental risk assessment for medicines such as hormones antineoplastic agents, radiopharmaceuticals, and any other deemed necessary by the competent authority; and (h) a fee of one hundred dollars for each drug per importer. (2) All documents required under this regulation for the registration of a drug shall be in the English language and if not in the English language, the applicant shall provide the competent authority with an English translation of the document attached to the original.