Individuals intending to perform the duties of a qualified person must submit an application to the Drugs Council, in the manner defined by the Drugs Council, which is accompanied by all the required justifications and the prescribed fees.
Each qualified person receives registration approval from the Drugs Council, which is recorded in the Qualified Persons Register. Each entry into this Register is published in the Official Gazette of the Republic of Cyprus.
Qualification of the Qualified Person
The qualified person must fulfil the following requirements in relation to their qualifications:
(a) shall possess a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognised as equivalent to this by the Republic of Cyprus, 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 Medicine, 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 a minimum duration of one (1) year and including a training period of at least six (6) months in a pharmacy open to the public, corroborated by an examination at university level.
Furthermore, where two (2) university courses, or two (2) courses recognised by the Republic of Cyprus as equivalent to this, co-exist and where one of these extends over four (4) years and the other over three (3) years, the 3-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 by Cyprus.
(b) at least two (2) years of practical experience, 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 control necessary to ensure the quality of medicinal products:
The duration of practical experience may be reduced by one (1) year where a university course lasts for at least five (5) years and by a year and a half where the course lasts for at least six (6) years.
The course shall include theoretical and practical study 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 natural active substances of plant and animal origin)