TITLE IV

MANUFACTURE AND IMPORTS
Article 53
1
Member States shall ensure that the qualified person referred to in Article 52(1) fulfils the conditions of qualification referred to in paragraphs 2 and 3.
2
The qualified person shall 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 recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary science, chemistry, pharmaceutical chemistry and technology, biology.
However, the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of at least one year and includes a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level.
Where two university or recognized equivalent courses coexist in a Member State and where one of these extends over four years and the other over three years, the diploma, certificate or other evidence of formal qualifications awarded on completion of the three-year university course or its recognized equivalent shall be considered to fulfil the condition of duration referred to in the first subparagraph in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognized as equivalent by the State in question.
The course shall include theoretical and practical tuition bearing upon at least the following basic subjects:
- experimental physics,
- general and inorganic chemistry,
- organic chemistry,
- analytical chemistry,
- pharmaceutical chemistry, including analysis of medicinal products,
- general and applied biochemistry (medical),
- physiology,
- microbiology,
- pharmacology,
- pharmaceutical technology,
- toxicology,
- pharmacognosy (study of the composition and effects of the active principles of natural substances of plant and animal origin).
Tuition in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in Article 55.
In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in this paragraph do not fulfil the criteria laid down above, the competent authority of the Member State 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.
3
The qualified person shall have acquired practical experience over at least two years, in one or more undertakings which are authorized 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.
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.
Substituted by Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products.