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Glossary for C
CA – Competent Authority
A body which has the authority to act on behalf of the government to ensure that legislation is implemented and followed. The IMB is the Competent Authority for human and veterinary medicines, medical devices, cosmetic products, blood and blood components, tissues and cells.
CE mark
A symbol on a medical device and its packaging which indicates that it meets the basic requirements for safety and effectiveness under European law.
Centralised procedure
A procedure used by pharmaceutical companies to obtain an authorisation for a medicine which allows them to sell it in all EU countries. Under this procedure, companies submit one single application to the European Medicines Agency. The application is assessed by experts from two different EU countries (called the 'rapporteur' and 'co-rapporteur'). The authorisation is granted by the European Commission and allows the medicine to be marketed in all EU Member States.
CFS – Certificate of Free Sale
Certificates of Free Sale are granted by the IMB and other regulatory agencies in the EU. Companies must have these before they can export medicines or medical devices to countries outside the EU (‘third countries').
CHMP – Committee on Medicinal Products for Human Use
A scientific committee at the European Medicines Agency which gives opinions on the authorisation (or approval) of medicines for human use to the European Commission and develops guidelines on authorisation applications for pharmaceutical companies and medicines agencies.
Clinical investigation
An investigation to study the safety and/or performance of a medical device.
Clinical trial
An investigation to study the safety or effectiveness of a medicine. The results of trials are reviewed by the regulatory authorities to determine if a product can be authorised.
CMD – Coordination Group for Mutual Recognition and Decentralised procedures (human)
A committee of representatives of the medicines agencies in the EU and EEA which addresses procedural, regulatory and scientific issues relating to specific applications for marketing authorisations for medicines for human use (CMDh) or veterinary use (CMDv).
CMS – Concerned Member State / RMS – Reference Member State
See Decentralised procedure.
Controlled drug
A substance which has the potential for abuse and is controlled under the Misuse of Drugs Acts 1977 and 1984. Examples include cocaine and morphine.
Co-rapporteur
See Centralised procedure.
Cosmetic products
Cosmetic products are intended to be applied to the skin or to body cavities for cleaning, perfuming, protecting and maintaining health. If they are applied into the eye or nasal cavity, they are regarded as medicinal products or medical devices.
CVMP – Committee for Medicinal Products for Veterinary Use
A scientific committee at the European Medicines Agency which gives opinions on the authorisation of medicines for veterinary use to the European Commission and issues guidelines on authorisation applications applications to pharmaceutical companies and medicines agencies.