S.L. 458.36 Art. 10Exemptions for existing qualified person.

(1) The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course, or a course recognised as equivalent, in a scientific discipline allowing him to perform the duties of a qualified person, may, if he began his course prior to the 21st May, 1975, be considered as qualified to carry out the duties of a qualified person, provided that he was, for at least two years before the 21st May, 1985, engaged with one or more undertakings authorised to manufacture, and as having carried out the duties of production supervision and, or qualitative and quantitative analysis of active substances, and the necessary testing and checking under the direct authority of a qualified person in order to ensure the quality of the medicinal products.

(2) If the person concerned has acquired the practical experience referred to in subregulation (1) before the 21st May, 1965, a further one year’s practical experience in accordance with the conditions referred to in subregulation (1) will be required to be completed immediately before he engages in such activities.

(3) A person engaging in the activities of a qualified person from the time of the application of Directive 75/319/EEC in a Member State without complying with the provisions of regulation 9 shall be eligible to continue to engage in those activities within the Community.