Application for amendment of product licence, upon change of circumstances

(1) If, after a product licence is granted, a change has occurred in relation to any required information or documents supplied upon application for the product licence, the licensee shall make an application to the competent authority for approval of amended registration of the drug concerned using the modified information or documents, in the form set out as Form 1 in Schedule I, and accompanied byForm 1. Schedule I. (a) the fee of fifty dollars; and (b) the relevant documents with the amendments. (2) The competent authority may grant an amended product licence if the applicant satisfies the requirements for the registration of a drug under this regulation. (3) Where the competent authority grants an amended product licence, the competent authority shall provide the applicant with an amended registration code. (4) A licensee who fails to notify of a change under paragraph (1), or notwithstanding such a change, operates without an amended product licence commits an offence and is liable on summary conviction to a fine not exceeding ten thousand dollars.