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Parliamentary questions
28 March 2018
E-000714/2018
Answer given by Mr Andriukaitis on behalf of the Commission

The Commission is aware of the adverse effects and misuse of opioids including codeine and is closely following the situation.

Codeine-containing medicines are authorised nationally in the EU, i.e. the marketing authorisations for these products are managed by the national competent authorities and are available either on prescription or over the counter in the different Member States.

Many have been on the market for a long time and have restricted use, e.g. contraindicated for children and patients known to be ultra-rapid metabolisers. The mandatory product information documents advise on the safe use of the products including potential risk of abuse. Controlling the package size is also one of the safety measures. The adverse events and misuse are monitored through pharmacovigilance processes to be followed by marketing authorisation holders, the Member States and the European Medicines Agency (EMA).

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and EMA are closely working together and further information on codeine misuse is available e.g. in the European Drug Report 2017(1).

(1)http://www.emcdda.europa.eu/publications/edr/trends-developments/2017

Last updated: 4 April 2018Legal notice