Brussels, 09/02/2016 (Agence Europe) - The majority of medicines marketed in the European Union will have to contain a security mechanism proving their authenticity as from 2019. This is stipulated in a delegated regulation published on Tuesday 9 February in the European Union's Official Journal.
Falsifiers are false medicinal products that have been authorised as authentic medicines. Given that they have not been subject to quality assessment procedures on safety and efficiency, as required by EU legislation, they could constitute a serious health risk. In June 2011, the European Parliament and Council therefore agreed to step up the fight against this kind of medicine by introducing a unique identifier (a series of digital or alpha numerical letters) on packaging. This provision in the 2011/62/EU regulation on falsified medicines (amending the 2001/83/EC directive on medicines for human use) is expected, however, to be further clarified through a Commission delegated act.
The delegated act in question was published on 2 October by the Commission. It sets out a system in which the identification and authentication of medicines are guaranteed by an end-to-end verification of all medicinal products bearing the safety features, supplemented by the verification by wholesalers of certain medicinal products at higher risk of falsification. More particularly, it defines the characteristics and technical specifications of the unique identifier, the verification modalities, as well as the list of medicines and categories of medicines on prescription that should not be given security mechanisms. It also sets out procedures for notifying the Commission of medicines that are not subject to prescription and where there is a risk of falsification. The delegated regulation, 2016/161, will apply as from 9 Febraury 2019 (or 2025 for member states that have an exemption). (Original version in French by Sophie Petitjean)