Suitable education and work experience

The person responsible for the release of individual series of medicinal products must hold a second level education or level of education which as per the law complies with this level in the field of pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, technology or biology.

The programme of education under the preceding paragraph encompasses knowledge of applied physics, general chemistry, inorganic chemistry, organic chemistry, analytical chemistry, pharmaceutical chemistry, including analysis of medicinal products, general and applied medicinal biochemistry, physiology, microbiology, pharmacology, pharmaceutical technology, toxicology and pharmacognosy.

If the study programme does not include any of the aforementioned fields, the responsible person must submit suitable certificates on additional education rendered.

In addition to the required education, the responsible person must also obtain work experience with manufacturers of medicinal products who have a manufacturing authorisation for medicinal products, of which they must have at least two years of practical experience in the field of quality analysis of medicinal products, quantitative analysis of substances, and testing and verifying for the needs of ensuring the quality of medicinal products. The period of required practical experience may be reduced by one year if the study programme is for at least five years, or by 18 months if the programme takes at least six years.

Supporting evidence

Diploma: certified copy or non-certified copy and the original provided on request. Certificate of acquired work experience

Last updated: 08. 01. 2016