Safety features for medicinal products

Directive 2011/62/EU was introduced to fight against falsified medicines; it introduces obligatory 'safety features' for medicinal products for human use, known as ‘unique identifiers’, to allow verification of the authenticity of the medicinal products. This Directive has placed the Commission under an obligation to adopt Delegated Acts setting out the details for implementation. A concept paper was launched by the European Commission for public consultation with a deadline of 27 April 2012 with a view to preparing both the impact assessment and the Delegated Act.

The Commission received responses from more than 70 stakeholders, including ECHAMP; these have now been published on the website of DG Sanco: http://ec.europa.eu/health/human-use/falsified_medicines/developments/2012-06_pc_safety-features.htm

In its response, ECHAMP advocates a category-based exemption from applying the costly safety features to homeopathic and anthroposophic medicinal products, on the basis that the sales figures and turnover of homeopathic and anthroposophic medicinal products on prescription mean that they are very unlikely to be falsified.

18 June 2012