english.prescrire.org > Spotlight > Archives : 2011 > Packaging for non-prescription medicines: the European Medicines Agency needs to rethink the regulations governing self-medication

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Packaging for non-prescription medicines: the European Medicines Agency needs to rethink the regulations governing self-medication

In its response to the European Medicines Agency's public consultation on draft recommendations for packaging of non-prescription drugs, Prescrire makes the case for stronger regulation to protect the European public.

In 2011, the European Medicines Agency (EMA) released draft recommendations for public consultation on the packaging of centrally authorised non-prescription drugs, which particularly addressed their labelling.

A summary of opinion of the Prescrire team on these draft recommendations is presented below; the complete reponse with its appended references is available for download below. 

The EMA and the European Commission need to rethink the regulations governing self-medication and safe, easy-to-use medicines. This consultation does not go far enough, as it seeks to accommodate the pharmaceutical companies.

European patients expect high quality healthcare, and the EMA therefore has a duty to show an interest in the packaging of non-prescription drugs used to treat common conditions ("self-medication products"). The quality and rational use of these drugs must take priority, and the packaging of self-medication products must not be allowed to be used to display promotional messages or as children’s toys.

But the nature and scope of the QRD Working Group’s recommendations, which have been under consultation since March 2011, are insufficient. These recommendations stand little chance of being useful to European patients until they are accompanied by:

  • A policy on self-medication that focuses on the needs and health of European populations, giving priority to the safe naming of drugs, with the international nonproprietary names (INNs) being prominently displayed on the packaging; by prohibiting umbrella brand names and ensuring that dose strengths and concentrations are not expressed in a way that endangers patient safety;
  • Closer monitoring by the European Commission and agencies responsible for drug safety (both centralised and national) to ensure that the current provisions of the European Directive on high-quality packaging design are interpreted optimally;
  • A Directive or Regulation to raise packaging standards, which are currently too lax, to the level required for quality care, including in particular:
    • extending readability testing and user testing to all the information displayed on all packaging articles (including dosing devices);
    • strengthening the evaluation of packaging by drug regulatory agencies (both centralised and national); adding colour mock-ups of the immediate and outer packaging and package leaflets to marketing authorisation (MA) annexes (for new authorisations and major variations); systematically adding a detailed diagram of dosing devices to SPCs and package leaflets (together with precise instructions for their use).

©Prescrire 4 July 2011

> Download Prescrire's complete response, with references

Prescrire’s response to
the public consultation
on EMA/275297/2010
"Draft - QRD recommendations
on pack design and labelling
for centrally authorised
non-prescription human
medicinal products".
Pdf, free

Prescrire's annual review
of drug packaging in 2010
(June 2011)

The 2010 Prescrire
Packaging Awards
(March 2011)