Responsible person for launching individual lots of medicinal products

The producer of medicinal products must conclude a contract with a responsible person who is qualified for launching an individual lot of a medicinal products and is constantly available. In the case of associated companies, this person can have a contract concluded with one of them if the delimitation of responsibilities and competences of individual units is legally and organisationally arranged. The responsible person for launching individual lots of medicinal products must have appropriate education and work experience and be entered in the register of responsible persons for launching medicinal products.

Last updated: 21. 12. 2015