Measures for additional protection of patients from falsified medicinal products based on the Commission Delegated Regulation (EU) 2016/161 and plans for introduction of new safety features
Falsified medicinal products are fake medicinal products that pass themselves off as real, authorised medicinal products. In July 2011, the EU strengthened the protection of patients and consumers by adopting the Directive 2011/62/EU of the European Parliament and of the Council on falsified medicinal products for human use. Further to this directive, Commission Delegated Regulation (EU) 2016/161 has been adopted and published on 9 February 2016 in the Official Journal of the European Union. The delegated regulation introduces two new safety features, a unique identifier (a 2-dimension barcode) and an anti-tampering device, to be placed on the packaging of most medicinal products for human use. Marketing-authorisation holders are required to place the safety features on the packaging of most prescription medicinal products and certain non-prescription medicinal products no later than 9 February 2019.
In order to help applicants and marketing-authorisation holders in meeting the requirements of the new regulation, implementation plans for introduction of new safety features have been published:
- for centrally authorised medicinal products - on EMA's website,
- for nationally authorised medicinal products as well as medicinal products authorised via MRP/DCP procedures - on CMDh's website.
In line with the adopted directive, product information templates for human medicinal products authorised via centralised and MRP/DCP procedures have been revised to enable implementation of the new rules.
HALMED will publish the new version of templates for nationally authorised medicinal products shortly.