Companies providing clinical trial supply services to sponsors and contract research organisations (CROs) need to comply with a complex framework of regulatory requirements and industry standards. To ensure that the integrity of the supply chain of pharmaceutical products remains intact in the European Union (EU), a series of regulatory measures have been adopted by the European institutions and the European Medicines Agency (EMA) in the last decade. Tibor KOVÁCS at PHARMAROAD KFT. exams the role of the falsified medicines directive and delegated regulation in the supply chain of clinical trials.
The Role of The Falsified Medicines Directive and Delegated Regulation in The Supply Chain of Clinical Trials
To ensure that the integrity of the supply chain of pharmaceutical products remain intact in the European Union (EU), a series of regulatory measures have been adopted by the European institutions and the European Medicines Agency (EMA) in the last decade. The implementation of the Falsified Medicines Directive (2011/62/EU) and Delegated Regulation (EU/2016/161) were among the leading initiatives to prevent the entry of falsified medicinal products into the legal supply chain. These regulatory instruments led to the creation of the European Medicines Verification System (EMVS), an overarching, EU-wide IT infrastructure linking a series of national data depositories to a central EU hub. The directive and delegated regulation also introduced the mandatory placement of safety features – a unique identifier (UD) and an anti-tempering device (ATD) – on each box of prescription medicine produced after the implementation date.
In addition, the new regulatory framework obliges manufacturers, wholesalers, and persons authorised or entitled to supply medicinal products to the public (e.g., pharmacies) to perform certain tasks related to the safety features. Along the different phases of the pharmaceutical supply chain, the authenticity of the unique identifiers and the integrity of the anti-tampering devices are to be verified by the different stakeholders. Also, at certain stages of the distribution process and for specifically designed purposes, the unique identifiers are to be decommissioned and hence removed from commercial circulation. The Delegated Regulation unambiguously defines the responsibilities of each stakeholder with regards to when, how and why they must verify and decommission safety features. Instructions in the Delegated Regulation cover various contexts of distribution, such as when products are supplied to the public, exported outside of the EU, provided to the authorities as samples or subjected to further manufacturing processes for clinical trial purposes.
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