S.L. 437.47 Art. 47Qualifications of the qualified person.

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

(a) a diploma;

(b) certificate or other evidence of formal qualifications awarded on completion of a university course of study; or

(c) a course recognised as equivalent by the territory of Malta, extending over a period of at least four (4) years of theoretical and practical study in one of the following scientific disciplines - pharmacy, medicine, veterinary science, chemistry, pharmaceutical chemistry and technology, biology.

(2) However, the minimum duration of the university course may be three and a half (3.5) years where the course is followed by a period of theoretical and practical training of at least one (1) year and includes a training period of at least six (6) months in a pharmacy open to the public, corroborated by an examination at university level.

(3) The course shall include theoretical and practical tuition bearing upon at least the following basic subjects:

(a) experimental physics;

(b) general and inorganic chemistry;

(c) organic chemistry;

(d) analytical chemistry;

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

(f) general and applied biochemistry (medical);

(g) physiology;

(h) microbiology;

(i) pharmacology,

(j) pharmaceutical technology;

(k) toxicology;

(l) pharmacognosy (study of the composition and effects of the active principles of natural substances of plant and animal origin).

(4) Tuition in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in regulation 49.

(5) Where certain diplomas, certificates or other evidence of formal qualifications mentioned in this sub-regulation do not fulfil the criteria laid down above, the Veterinary Services shall ensure that the person concerned provides evidence that he has, in the subjects involved, the knowledge required for the manufacture and control of veterinary medicinal products.

(6) The qualified person shall have acquired practical experience over at least two (2) years, in one or more undertakings which are authorised manufacturers, 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 veterinary medicinal products.

(7) 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 (6) years.