Health Products (Therapeutic Products) Regulations 2016 · As enacted · Part 6 · Duties and Obligations of Manufacturers, Importers, Etc., of Therapeutic Products
39. Responsible person
Feedback & supportA licensee must appoint one or more persons as a responsible person to be named as such in the licence.
The licensee must ensure that —
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.
The licensee must ensure that the responsible person discharges the duties imposed on such a person by the terms of the licence.
The licensee must ensure that no person, other than the person or persons named as the responsible person in the licence, may act as the responsible person.
Subregulation 1
A licensee must appoint one or more persons as a responsible person to be named as such in the licence.
Subregulation 2
The licensee must ensure that —
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.
Subregulation 3
The licensee must ensure that the responsible person discharges the duties imposed on such a person by the terms of the licence.
Subregulation 4
The licensee must ensure that no person, other than the person or persons named as the responsible person in the licence, may act as the responsible person.