Regulation (EU) 2019/6 on veterinary medicinal products came into force on 28 January 2022. As a result, Articles 211-213 (qualified persons) of Chapter 2 of the Royal Decree of 14 December 2006 on medicinal products for human use and veterinary medicinal products, no longer apply. The new legislation has a number of implications for qualified persons.
Since 28 January 2022, a distinction is made between:
- a qualified person for medicinal products for human use (QPHum) who's only authorised to release medicinal products for human use;
- a qualified person for veterinary medicinal products (QPVet) who's only authorised to release medicinal products for veterinary use.
Qualified persons who were recognized until 27 January 2022 can continue to release both medicinal products for human and veterinary use.
Some provisions must be taken into account with regard to the internship of QP candidates.
- A QPVet candidate must complete the internship in a company with a manufacturing authorisation for veterinary medicinal products. (implementation of Article 97 of Regulation 2019/6).
- A QPHum candidate must complete the internship in a company with a manufacturing authorisation for veterinary medicinal products or a manufacturing authorisation for medicinal products for human use (implementation of Articles 84-86 of the Royal Decree of 14 December 2006).
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