The legal duties of the Qualified Person are defined in Directive 2001/83/EC, for marketed human medicines; Directive 2001/82/EC, for marketed veterinary medicines and Directive 2001/20/EC for investigational human medicinal products.

The legal duties of the Qualified Person, as defined in Directives 2001/83/EC (human medicines) and 2001/82/EC (veterinary medicines) are the same; to ensure that…

  • Each batch of products has been manufactured and tested in compliance with...

o   National Law

o   The requirements of the Marketing Authorization

  •       Each batch of product imported from outside the Community has undergone, in the EU (this used to state in the importing Member State), …

o   Full qualitative analysis

o   Quantitative analysis of at least all the active constituents

o   All other tests to show compliance with the Marketing Authorization

Note: Exemptions from import testing are possible where Mutual Recognition Agreements (see Appendix 1) is in place between the EU and the third country. Qualified Person Release is still requited however for example, based upon a Certificate of Analysis approval, examination of the shipment, and possibly some reduced testing to ensure safe transit.

Where the product is released for sale, the Qualified Person must certify in a register or equivalent document that the above-mentioned provisions have been satisfied.

The legal duties of the Qualified Person, as defined in Directives 2001/20/EC for investigational medicinal products (IMPs) are…

·        Ensure that products manufactured and assembled according to:

o   GMP

o   Product specification file

o   Appropriate authorizations

·        All testing has been carried out and results comply with the product specification.

·        That IMP imported from outside EU have been manufactured to GMP at least equivalent to 2003/94/EC

·        Those comparators sourced outside the EU have been manufactured to GMP at least equivalent to 2003/94/EC

·        QP certificated in a register or an equivalent document that the product has fulfilled the requirements and can be released for clinical evaluation.

Note: There is a clear distinction between batch certification and batch release. Certification must be performed by a QP; release need not. Certification must precede release.


QP Discretion

The legal and routine duties of the Qualified Person are laid down in European directives but what authority does the Qualified Person have in the case of “grey area” decisions regarding the certification of batches?

For example, if a batch of tablets was shown to be thicker than the specification by a fraction of a millimeter, but all other tests are OK, including dissolution, and the tablet fits comfortably into the blister at packing, does the QP have the authority to release the batch?

For years, QPs in Europe assumed that they had this authority. If they did not, what was the point in demanding such high education and experience requirements for the QP – after all, a LIMS system can compare analytical results with a specification!