The alarming increase of falsified medicinal products in Europe has already been discussed in one of our previous articles. Passing themselves as the real, authorized medicines while containing ingredients which are of bad quality or in wrong dosages, falsified medicinal products are a major threat to public threat and safety – given that consumers might not be always able to discover their true identity.
The first step towards preventing the market entry of falsified medicinal products and foreseen by Directive 2001/83/ΕC, was the adoption of a new common logo which allows purchasers to verify if the medicinal products are authentic by being able to check first-hand if a pharmacy is registered to the national list or not. Following this, a new EU Regulation 2016/161 amends EU Directive 2001/83/ΕC and requires placing safety features such as unique identifiers and anti-tampering devices on the packaging of certain medicinal products for human use, in order to secure their authentication. Moreover, the EU Regulation 2016/161 creates an end-to-end authentication system from the wholesaler side, especially for products with higher falsification risk.
Specifically, technical specifications are adopted according to which marketing authorization holders must create unique identifiers which include the product code, the national reimbursement and identification number, the batch number and expiry date. This unique datasets therefore contribute to patient safety by facilitating recall, withdrawal, return procedures and pharmacovigilance across the entire supply chain.
The Regulation also sets a series of general provisions on verifying these safety features. The verification of the authenticity of the unique identifier aims at ensuring that the medicinal product originates from a legitimate manufacturer. And therefore in total, the Regulation foresees specific actions that manufacturers have to take in order to ensure the authenticity of their products as well as by wholesalers and persons authorized or entitled to supply medicinal products to the public who must verify the existence of safety features.
Finally, it is stipulated that this multi-channel verification system requires setting a repositories system which stores, inter alia, the information on the legitimate unique identifiers of a medicinal product and can be queried for the purposes of verifying the authenticity of and the decommissioning of this unique identifier. In article 31 of the Regulation states that the repositories system shall be set up and managed by a non-profit legal entity or non-profit legal entities established in the Union by manufacturers and marketing authorization holders of medicinal products bearing the safety features. It is also worth noting that wholesalers and persons authorized or entitled to supply medicinal products to the public will also be entitled to participate in the legal entity or entities on a voluntary basis, at no cost.
EU Regulation 2016/161 shall apply from 9 February 2019 binding thereof all marketing-authorization holders who must comply with the existing regulatory context and adopt all foreseen safety features.
Our law firm’s comment:
We consider the adoption of the new EU Regulation 2016/161 of particular importance as it enforces and improves the existing rules regarding the prevention of entry chain of falsified medicinal products into the legal supply, significantly contributing to public safety. Hence, the present legal context as supplemented by the new Regulation does not only aim to prevent falsified medicines entering the legal supply chain and reaching patients but also to allow European citizens to buy quality medicines through verified sources.