Regulation 39

the responsible person has adequate knowledge of the activities to be carried out and of the procedures to be performed under the licence;

the responsible person has relevant working experience relating to those activities and procedures;

in the case of a manufacturer’s licence, the responsible person named in the licence has practical experience in production supervision or in testing and checking to ensure the quality of therapeutic products or related health products;

in the case of an importer’s licence or wholesaler’s licence for the import or supply of any therapeutic product that is not registered at the request of a qualified practitioner for the use of the qualified practitioner’s patient, the responsible person named in the licence is a qualified pharmacist or such other person as the Authority may approve;

in the case of an importer’s licence or a wholesaler’s licence for the import or supply by wholesale of prescription-only medicine or pharmacy-only medicine, the responsible person named in the licence is a qualified pharmacist or such other person as the Authority may approve; and

at any time, there is at least one responsible person who is contactable by the Authority by way of a mobile telephone number or an email address.