1. A person must satisfy the requirements in paragraphs 2 and 8 or, alternatively, the requirements in paragraphs 7 and 8, of this Schedule before acting as a qualified person (but this is subject to Part 2).U.K.
2. The person must have a degree, diploma or other formal qualification which satisfies the requirements of this Part, in one of the following subjects—U.K.
(a)pharmacy;
(b)medicine;
(c)veterinary medicine;
(d)chemistry;
(e)pharmaceutical chemistry and technology; or
(f)biology,
but this paragraph is subject to paragraph 7.
3. A qualification satisfies the requirements of this Part if it is awarded on completion of a university course of study, or a course recognised as equivalent by the member State in which it is studied, which—U.K.
(a)satisfies the minimum requirements specified in paragraph 4; and
(b)extends over a period of at least four years of theoretical and practical study of a subject specified in paragraph 2 (but this is subject to paragraphs 5 and 6).
4.—(1) A course should include at least the following core subjects—U.K.
(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 medical biochemistry;
(g)physiology;
(h)microbiology;
(i)pharmacology;
(j)pharmaceutical technology;
(k)toxicology; and
(l)pharmacognosy.
(2) The subjects mentioned in sub-paragraph (1) should be balanced in such a way as to enable the person to fulfil the obligations specified in Part 3 of this Schedule.
5. If the course referred to in paragraph 3 is followed by a period of theoretical and practical training of at least one year, including a training period of at least six months in a pharmacy open to the public and a final examination at university level, the minimum duration of the course is three and a half years.U.K.
6. If two university courses, or courses recognised as of university equivalent standard, co-exist, one of which extends over four years and the other over three years, the three-year course is to be treated as fulfilling the condition as to the duration of the course in paragraph 3, provided that the member State in which the courses take place recognises the formal qualifications gained from each course as being equivalent.U.K.
7. If the person's formal qualifications do not satisfy the requirements of this Part, the person may act as a qualified person if the licensing authority is satisfied, on the production of evidence, that the person has adequate knowledge of the subjects specified in paragraph 4(1).U.K.
8.—(1) The person must (subject to sub-paragraph (2)) have at least two years' practical experience in an undertaking authorised to manufacture medicinal products of—U.K.
(a)qualitative analysis of medicinal products;
(b)quantitative analysis of active substances; and
(c)the testing and checking necessary to ensure the quality of medicinal products.
(2) But—
(a)if the person has completed a university course lasting at least five years, the minimum period of practical experience under this paragraph is one year; and
(b)if the person has completed a university course lasting at least six years, the minimum period of practical experience under this paragraph is six months.