May QPs recognised before 28 January 2022 still release batches of veterinary medicinal products?
Yes, QPs that were recognised before Regulation (EU) 2019/6 came into effect on 28 January 2022 may still release batches of veterinary medicinal products in addition to batches of medicinal products for human use.
May a QPHum recognised from 28 January 2022 release batches of veterinary medicinal products?
A QPHum may only release batches of medicinal products for human use.
May a QPVet recognised from 28 January 2022 release batches of medicinal products for human use?
A QPVet may only release batches of veterinary medicinal products.
Is the national equivalence test applied to QPVet university degrees?
In application of Article 97, paragraph 5 of Regulation (EU) 2019/6 this is still possible. It is up to the applicant to demonstrate the equivalence of a university degree.
Where should internships for QPVet be performed?
In accordance with Article 97 of Regulation (EU) 2019/6, practical experience must be acquired in one or more companies with a manufacturing authorisation for veterinary medicinal products.
Where should internships for QPHum be performed?
In accordance with Article 84 of the Royal Decree of 14 December 2006, practical experience must be acquired in one or more companies with a manufacturing authorisation for veterinary medicinal products or medicinal products for human use.
Who may sign the internship certificates?
The certificate is made with company letterhead and signed by the QP, QPHum or QPVet of the internship.
A QP with recognition before 28 January 2022 may issue internship certificates for both QPVet and QPHum candidates for the respective manufacturers (for medicinal products for human use or medicinal products for veterinary use).
A QPVet with recognition from 28 January 2022 may issue internship certificates for both QPVet and QPHum candidates for the respective manufacturers.
A QPHum with recognition from 28 January 2022 may only issue internship certificates for QPHum candidates for the respective manufacturers.
Will QP applications that were submitted before 28 January 2022 and that are still pending, still be processed under the provisions of the Royal Decree of 14 December 2006?
No, as no transitional provisions have been laid down for Article 97, all pending applications must be treated according to the provisions of Regulation (EU) 2019/6.
For persons who received an ordinary QP number since 28 January 2022, all concerned applications will be re-evaluated and adjusted where necessary to comply with the amended legislation.