8.—(1) Where the holder of a marketing authorisation imports the products to which the authorisation relates from outside the European Economic Area, he shall comply with the provisions of this regulation.
(2) He shall have permanently and continuously at his disposal the services of at least one Qualified Person, who satisfies the requirements as to qualifications and experience set out in article 31 of Council Directive 81/851/EEC, or who is permitted to act as a Qualified Person by virtue of the provisions of article 32 of that directive.
(3) He may himself undertake the duties of the Qualified Person if he satisfies the provisions of article 31 or 32 of that directive.
(4) The Qualified Person shall be responsible in particular for carrying out the duties specified in article 30.1(a) and 30.1(b) of that directive, and article 30.2 of that directive.
(5) Where, after the holder of the marketing authorisation and the person acting as Qualified Person have been given the opportunity to make written or oral representations, the Ministers have served written notice on the holder of the marketing authorisation stating that the person acting as Qualified Person does not satisfy the requirements of article 31 or 32 of Council Directive 81/851/EEC, or that the person has failed to carry out the duties required by this regulation, which notice has not been withdrawn, the holder of the marketing authorisation shall not permit that person to act as a Qualified Person for him.