Informative Notice
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Person responsible for the quality of medicinal products
A business entity that produces non-routinely prepared medicinal products, must appoint a person responsible for the quality of non-routinely prepared advanced therapy medicinal products for progressive treatment, who is responsible that the preparation of the non-routinely prepared advanced therapy medicinal product is in accordance with the valid regulations.
Conditions
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An individual must have a secondary level of education in medicine, pharmacy, veterinary medicine or biomedicine or another suitable level of education compliant as per the law and additional knowledge in this field.
Evidence
Diploma - certified copy or non-certified copy and the original provided on request. Certificate of additional knowledge
Legal basis
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An individual must have at least two years of practical experience in the field of preparing non-routinely prepared medicinal products for advanced therapy.
Evidence
Evidence of work experience
Legal basis
Recognition of qualifications acquired abroad
There are following systems for the recognition of professional qualifications acquired in the EU: