Who is a qualified person for Directive 2001 83 EC?: The Path to Pharmaceutical Authority

October 8, 2025 •

2 min read

In the European Union, no medicinal product can be released for sale without a Qualified Person's certification. So, who is a qualified person for Directive 2001 83 EC, and what stringent criteria must they meet to uphold public health standards and ensure pharmaceutical quality?

Quick Summary

A Qualified Person (QP) under Directive 2001/83/EC must hold a university degree in a relevant scientific field and have substantial practical experience in pharmaceutical manufacturing to certify batch release. The role is critical for upholding EU Good Manufacturing Practice.

Key Points

Mandatory Role: A Qualified Person (QP) is a legal requirement under Directive 2001/83/EC for any EU company holding a manufacturing license for medicinal products.
Rigorous Education: To become a QP, an individual must possess a university degree (at least four years) in a specific scientific field like pharmacy, medicine, or chemistry, covering a defined curriculum of subjects.
Extensive Experience: Candidates must complete a minimum of two years of practical experience in pharmaceutical manufacturing, focusing on quality control activities such as qualitative and quantitative analysis.
Personal Accountability: The QP bears personal legal responsibility for certifying each batch of a medicinal product, guaranteeing its compliance with EU GMP and the marketing authorization.
Independent Authority: A QP's decision to release or reject a batch cannot be overridden by company management, emphasizing their independent authority in quality matters.
Import Oversight: For products imported into the EU, the QP must oversee re-testing and certification within an EU member state, ensuring compliance with EU standards.
Continual Assurance: The QP is integral to the entire Pharmaceutical Quality System, ensuring compliance not only at the time of batch release but also throughout the product's lifecycle.

The Foundation: Directive 2001/83/EC

Directive 2001/83/EC outlines the regulations for medicinal products for human use in the EU. It requires that every company with a manufacturing authorization in the EU must have access to at least one Qualified Person (QP). The QP is a European role with personal legal responsibility for the quality and safety of medicinal batches before they are released. Articles 48, 49, and 51 of the directive specifically detail the QP requirements.

Educational Requirements for a Qualified Person

Article 49 of Directive 2001/83/EC specifies the educational qualifications for a QP. Candidates need a university diploma or equivalent from a course lasting at least four years, including theoretical and practical training in specific scientific fields. Approved disciplines include Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, and Biology.

Core Subject Areas

The university course must cover essential subjects. If the degree doesn't cover these fully, the national competent authority may require evidence of additional knowledge. Key subjects include: Experimental physics, General and inorganic chemistry, Organic chemistry, Analytical chemistry, General and applied biochemistry, Physiology, Microbiology, Pharmacology, Pharmaceutical technology, Toxicology, and Pharmacognosy.

The Role of Practical Experience

In addition to academic qualifications, prospective QPs need at least two years of practical experience in pharmaceutical manufacturing, focusing on quality control activities such as qualitative and quantitative analysis of medicinal products. For university courses longer than four years, the practical experience requirement can be reduced. A five-year course may reduce the requirement to one year, and a six-year course to six months.

The Responsibilities of a Qualified Person

Article 51 outlines the critical duties of a QP. Before releasing a batch, the QP must certify in a register that it complies with national laws, the Marketing Authorization (MA), and EU Good Manufacturing Practice (GMP). For medicines imported into the EU, the QP must certify that each batch has undergone analysis within an EU Member State and verify that third-country manufacturing sites meet EU GMP standards through audits.

Comparison: EU Qualified Person vs. US Quality Assurance

The EU QP role differs significantly from roles in other regions, such as the US Quality Control Unit (QCU), particularly regarding legal accountability.


Feature	EU Qualified Person (QP)	US Quality Control Unit (QCU)
Legal Authority	Personal legal liability for certifying batches.	Corporate liability.
Batch Release	Personally certifies each batch before release.	Responsible for production record review and ensuring compliance.
Independence	Decisions cannot be overruled by company management.	Independent of production, but no individual legal authority.
Third-Country Imports	Requires re-testing and QP certification within the EU.	Compliance verified through quality agreements and record review.

Conclusion

The Qualified Person is essential to the EU's pharmaceutical quality system, ensuring high standards of safety and compliance. The requirement for a strong scientific education and practical experience equips QPs with the knowledge and authority to protect public health. Their personal responsibility in certifying each batch reinforces the integrity of the pharmaceutical supply chain and is a vital safeguard in European medicines legislation. The full text of Directive 2001/83/EC is available for further details.

Frequently Asked Questions

The primary role of a Qualified Person (QP) is to ensure and certify that each batch of a medicinal product has been manufactured and checked in compliance with EU laws, Good Manufacturing Practice (GMP) standards, and the product's marketing authorization before it is released for sale.

Acceptable university degrees include pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, and biology, provided the curriculum covers a specific set of theoretical and practical subjects.

Yes, the concept of a Qualified Person who bears personal legal responsibility for batch release is a unique requirement within the European Union and the European Economic Area. This is a key difference from regulatory systems in other regions, like the United States.

Yes, if a candidate has completed a longer university course of study (e.g., five or six years), the minimum two-year practical experience requirement may be reduced accordingly, based on the discretion of the national competent authority.

If a medicinal product is manufactured in a third country (outside the EU), a QP must ensure that it undergoes a full qualitative and quantitative analysis within an EU Member State and is certified before it is released for the EU market.

While a QA manager may oversee quality systems, the QP holds a specific legal and personal liability role for certifying batch release as mandated by EU law. The QP's authority regarding batch release is absolute and cannot be overruled by management.

A QP can be either a permanent employee or a contracted service provider, but they must be registered or approved by the competent authority of the Member State where they operate. They have the same duties and responsibilities regardless of their employment status.