Procedure on change of the nature of business and change in ownership

(1) The owner of a pharmaceutical facility shall apply in writing to the competent authority for approval if the owner of the pharmaceutical facility intends to expand or discontinue the nature of business to which the facility licence applies. 140 Food and Drugs (2) The competent authority may require the owner of a pharmaceutical facility to submit a new application if the competent authority considers the change in the nature of business to be substantial. (3) The new owner of a pharmaceutical facility shall apply for a new facility licence if there is a change in ownership of a licensed pharmaceutical facility. (4) For the purposes of this regulation, a change in ownership occurs when– (a) ownership and responsibility for the operation of the assets constituting the licensed pharmaceutical facility are transferred from the holder of the licence to another person; (b) there is a material change in a partnership that is caused by the removal, addition, or substitution of a partner; (c) in the case of ownership by a corporate body– (i) the holder of the licence merges into another corporate body; or (ii) there is the consolidation of two or more corporate bodies, one of which is the holder of the licence, resulting in the creation of a new corporate body; or (d) there is the leasing of all the pharmaceutical facility’s operations to another person.