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Parliamentary questions
2 September 2010
E-5907/2010
Answer given by Mr Dalli on behalf of the Commission

In the EU, European pharmaceutical legislation(1) already contains harmonised and very detailed rules aiming at ensuring quality, safety and efficacy of medicinal products, as well as their proper identification. Medicinal products can only be placed on the market after having been authorised centrally by the Commission or nationally by national competent authorities. Each marketing authorisation decision specifies in detail the labelling and package leaflet requirements for the product. These information requirements are intended to provide all necessary information for the correct use of the product, including the prevention of any use of the product by mistake. They are made subject to readability testing where specific risks are taken into consideration, for example, the needs of blind and partially-sighted patients.

In view of the above, the Commission does not see a need for legislation on smell identifiers for medicinal products nor to establish a committee for this matter.

(1)Directive 2001/83/EC, OJ L 311, 28.11.2001 and Regulation 726/2004, OJ L 136, 30.4.2004.

OJ C 216 E, 22/07/2011
Last updated: 13 September 2010Legal notice