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📌What Are the Core Legal Duties of the QP in the EU/EEA?

The responsibilities of a QP are detailed in Article 51 (human products) and Article 97(veterinary products).  A QP must ensure that every batch:

1. Is manufactured and tested in accordance with: national law, Good Manufacturing Practices (GMP), and the approved Marketing Authorisation.

1. For imported products, undergoes full qualitative and quantitative analysis within the EU/EEA, unless alternative justified arrangements are in place (between EU and exporting country) and GMP equivalence is demonstrated at the exporting site.

Detailed expectations for QP certification and confirmation are documented in:

• Annex 16 of EudraLex Volume 4 (batch certification/confirmation)

• Annex 21 of EudraLex Volume 4 (GMP requirements for imported products)

📌QP Responsibilities in the United Kingdom

The UK continues to follow a regulatory framework closely aligned with EU principles.  QP duties are established in the UK QP Code of Practice (April 2025) and further elaborated in MHRA Orange Guide – Annex 16 Part 1.

In the UK, the QP is responsible for:

• Certifying each batch before release

• Ensuring compliance with the Marketing Authorisation and applicable GMP

• Upholding professional and ethical obligations relating to patient safety, product quality, and product efficacy

📌How Other Regions Handle Batch Release (Without a QP)

Outside the EU/EEA and UK, most regions do not recognise the QP role in their legislation. Instead, batch release responsibilities are assigned differently:

In the United States, the responsibility lies with the Quality Unit under FDA regulations (21 CFR 211.165 for cGMP; 21 CFR 610 for biologicals).

In Japan, the Marketing Authorization Holder (MAH) bears legal responsibility for product quality and the accuracy of information supplied to the market. These obligations are embedded in the Good Quality Practice (GQP) framework, which connects manufacturing release and distribution requirements under the PMD Act.

In Brazil, batch release responsibility sits within the manufacturer’s QA/QC structure, as defined by ANVISA’s GMP requirements.

In Canada, the duty is assigned to a Responsible Person within the manufacturer’s quality system, as defined in Part C, Division 2 of the Food and Drug Regulations and detailed in the GMP guide GUI0001.

Switzerland is a special case: although not an EU Member State, its Mutual Recognition Agreement (MRA) with the EU obliges it to implement GMP principles that mirror those defined in EU legislation. Switzerland uses the designation Responsible Person (RP) – functionally equivalent to the EU QP, even though the terminology differs.

📌 When Is QP Certification or Confirmation Required?

Based on the EMA Q&A published in December 2025, QP certification or confirmation is required when anyof the following conditions are met:

• The batch is manufactured within the EU/EEA

• The batch is intended for the EU/EEA market, or for use in clinical trials in the EU

• The batch is physically imported into the EU/EEA and intended for the EU/EEA market, or for use in clinical trials in the EU.

📌When QP Certification Is Not Required ?

QP certification is not applicable if a batch is:

• not manufactured in the EU/EEA, and

• not intended for EU/EEA markets, and

• not physically imported into the EU/EEA.

In that case, activities do not fall under EU GMP oversight, are not subject to EU manufacturing/import authorisations.

By Joseph Kanyinda wa Kanyinda