The legal and regulatory basis of the Qualified Person

The primary legal responsibility of the QP is to certify batches of Medicinal Product prior to use in a Clinical Trial (human medicines) or prior to release for sale and placing on the market for both Human and Veterinary medicines.

Each holder of an Authorisation to manufacture products for use in a Clinical Trial or products subject to Marketing Authorisations, within Member States of the EU or in the United Kingdom, must name a person or persons who are eligible to act in the capacity of QP.

For ease of reference the key regulatory documents concerning the QP are listed below - in each case linked to the primary documentation.

• Directive 2003/94/EC - Principles and Guidelines of Good Manufacturing Practice for Medicinal Products for Human Use

• Directive 91/412/EEC – Principles and Guidelines of Good Manufacturing Practice for Veterinary Medicinal Products

• Directive 2001/20/EC – Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use and the repealing legislation in the EU - Regulation EU No 536/2014 and amendments in Regulation EU No 1569/2017

• Directive 2001/82/EC – Community Code Relating to Veterinary Medicinal Products

• Directive 2001/83/EC – Community Code Relating to Medicinal Products for Human Use

• Directive 2011/62/EC – Falsified Medicines Directive

• Eudralex Volume 4 – Good Manufacturing Practices. Specifically:

  • Annex 13 – Manufacture of Investigational Medicinal Products

  • Annex 16 – Certification by a Qualified Person and Batch Release

However it should be noted that the role of the QP is brought up in a rather scatter gun approach throughout other guidance documents.