The European Commission has published a guidance concerning “Safety Features for medicinal products for human use” (Guidance). The Guidance is in the form of a “Questions and Answers” document. It is intended to facilitate the implementation of the EU Falsified Medicines legislation.

Background

The Falsified Medicines Directive introduced the obligation to affix “safety features” on the packaging of most human medicines. In a related delegated act, the Commission Delegated Regulation, the characteristics of the required safety features were detailed. The manner in which the authenticity of a medicinal product should be verified, and by whom were also included in the Delegated Regulation.

The Delegated Regulation includes detailed rules concerning the safety features appearing on the packaging of medicinal products for human use. It also introduces a new medicine verification system. According to the Delegated Regulation, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public in the EU must verify the authenticity of the unique identifier and the integrity of the anti-tampering device (ATD).

The unique identifier is defined as the “unique sequence carried by a two-dimensional barcode allowing the identification and authentication of the individual pack on which it is printed”. The ATD allows the verification of the authenticity of medicinal products subject to prescription and strengthen the security of the medicine supply chain.

The Delegated Regulation applies to:

  • Medicinal products subject to prescription;
  • Medicinal products not subject to prescription included in the list set out in Annex II to the Regulation, namely omeprazole in a form of a gastro-resistant capsule in either 20mg or 40mg dosages;
  • Medicinal products to which the individual EU Member States have extended the scope of application of the unique identifier or of the ATD.

The Guidance

The Guidance provides answers to the most frequently asked questions concerning the implementation of the Falsified Medicines legislation. The document consists of seven parts. Each part discusses questions related to the safety measures that must be fulfilled in relation to the medicinal products governed by the Guidance.

The Guidance provides, however, that the rules concerning the new safety features do not apply to veterinary medicines. Neither do they apply to unauthorised medicinal products for human use intended for research and development trials.

According to the Falsified Medicines legislation, manufacturers of medicinal products must affix the new safety features to their products by 9th February 2019. The timeline for the application of the new safety features may, however, differ depending on the country. In particular the Guidance provides that Belgium, Greece and Italy may defer the application of the rules concerning the safety features for an additional period of up to six years.

The Guidance also addresses questions concerning the general characteristics of the safety features, the verification and decommissioning of the unique identifier by manufacturers, wholesalers, or authorised individuals to supply medicinal products to the public, and the technical specifications of the unique identifier.