Committee for Medicinal Products for Human Use (CHMP)

The Committee for Medicinal Products for Human Use is the scientific committee of the European Medicines Agency responsible for preparing its opinions on any question relating to medicinal products for human use. Established by Regulation (EC) No 726/2004, it is commonly known as the CHMP. In particular, it delivers the opinion on which the European Commission bases its authorisation decisions in the centralised procedure.

Composition of the Committee

The Committee comprises one member and one alternate appointed by each Member State, together with co-opted members chosen for their specific scientific expertise. Members mostly come from the national health authorities, and the Committee is thus the meeting point between the expertise of the Agency and that of the Member States. For each application, it appoints a rapporteur and a co-rapporteur, whose national teams carry out the assessment, and it relies on working parties and specialised scientific advisory groups.

Powers of the Committee

In the centralised procedure, the Committee assesses the quality, safety and efficacy of the medicinal product and adopts a positive or negative opinion, possibly subject to conditions. It also examines variations and renewals of centralised authorisations. It acts as arbitrator where Member States fail to agree in a mutual recognition procedure or a decentralised procedure, and where a safety issue justifies a Union-wide referral. Finally, in the course of the assessment, it rules on new active substance status and on the significant clinical benefit of a new indication, two assessments that determine regulatory protection.

Re-examination and appeals

Within 15 days of receiving the opinion, the applicant may give notice of its intention to request a re-examination, and must then set out its grounds within 60 days. The Committee then appoints new rapporteurs and delivers a final opinion. The Committee’s opinion is a preparatory act, and in principle only the Commission decision that follows it can be challenged by an action for annulment before the General Court of the European Union. Judicial review then covers the regularity of the procedure and the absence of a manifest error of assessment, given the complexity of the scientific evaluations involved.

Key points

The Committee for Medicinal Products for Human Use is where, in practice, the scientific fate of a centralised authorisation application is decided. Its opinion, formally preparatory, is followed by the Commission in the vast majority of cases. It also decides questions that directly affect the duration of protection, such as new active substance status. Exchanges with the rapporteurs should be carefully prepared and the re-examination time limits strictly observed, as they leave only a narrow window after a negative opinion.

---

This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

Pharmaceutical patents and medicines regulation · Pharma case law · Tell us about your situation