S.L. 458.36 Art. 9Qualified person.

For a person to be designated as qualified person, he must possess the following qualifications:

(a) (i) be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognised as equivalent, extending over a period of at least four years of theoretical and practical study in any of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology;

(ii) where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, such period being corroborated by an examination at university level, then the minimum duration of the university course may be three and half years;

(iii) where two university courses or two courses recognised as equivalent co-exist in a Member State, and where one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognised equivalent shall be considered to fulfil the condition of duration referred to above, in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognised as equivalent;

(b) the course shall include theoretical and practical study on at least the following basic subjects:

(i) experimental physics;

(ii) general and inorganic chemistry;

(iii) organic chemistry;

(iv) analytical chemistry;

(v) pharmaceutical chemistry, including analysis of medicinal products;

(vi) general and applied biochemistry (medical);

(vii) physiology;

(viii) microbiology;

(ix) pharmacology;

(x) pharmaceutical technology;

(xi) toxicology;

(xii) pharmacognosy (study of the composition and effects of the natural active substances of plants and animal origin);

(c) studies in these subjects shall be so balanced as to enable the qualified person to fulfil the obligations specified in regulation 11;

(d) in those cases where diplomas, certificates or other evidence of formal qualifications do not fulfil the criteria above mentioned, the Authority shall ensure that the person concerned provides evidence of adequate knowledge of the subjects involved;

(e) (i) the qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorised to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances, and of the testing and checking necessary to ensure the quality of medicinal products;

(ii) the duration of practical experience may be reduced by one year where a university course lasts for at least five years, and by a year and a half where the course lasts for at least six years.