On 9 February 2016, the European Commission published Commission Delegated Regulation (EU) No. 2016/161, supplementing Directive 2001/83/EC of the European Parliament and of the Council, by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use ("Delegated Regulation").
It is recalled that, to prevent the entry of falsified medicinal products into the supply chain in the European Union ("EU"), the Falsified Medicines Directive (Directive 2011/62/EU) introduced certain obligatory safety features on the packaging of medicinal products for the purposes of determining their authenticity and impede the distribution of falsified medicinal products. The purpose of the Delegated Regulation is, therefore, to detail the characteristics of the obligatory safety features for medicinal products introduced by the Falsified Medicines Directive. The safety features consist of two elements placed on the packaging of a medicinal product:
- a unique identifier; and
- a device allowing the verification of whether the packaging of the medicinal product has been tampered with (anti-tampering device).
A number of the requirements introduced by the Delegated Regulation are discussed within this briefing.
CHARACTERISTICS OF THE UNIQUE IDENTIFIER
Manufacturers are required to place a unique identifier on the packaging of medicinal products which would reflect certain specific technical specifications. Such specifications include:
- product code;
- serial number;
- national reimbursement number or other national number, where required by the applicable EU Member State;
- batch number; and
- expiry date.
The unique identifier must be encoded in a two-dimensional barcode which is commonly used for industrial and consumer goods. To demonstrate fulfilment of this requirement, manufacturers could rely on the ISO Electrotechnical Commission standard 16022:2006.
According to the Delegated Regulation, manufacturers, wholesalers and persons authorised or entitled to supply medicinal products to the public shall verify: (i) the authenticity of the unique identifier; and (ii) the integrity of the anti-tampering device.
The Delegated Regulation addresses the actions which must be performed by wholesalers and by persons authorised or entitled to supply medicinal products to the public in relation to the verification of the safety features. This includes verification through the use of a central repository system established by the Delegated Regulation which is discussed below.
Moreover, to accommodate the different characteristics of the individual EU Member States' supply chain, verification will be required before supplying medicinal products to certain persons and institutions listed in Article 23, which includes schools and universities.
A repository system will be established and will retain records of operations in relation to a unique identifier. Moreover, this system is intended to enable the investigation of suspected falsified medicinal products. Competent authorities of the EU Member States will be provided access to the repository system upon request.
The system will be set up and managed by a non-profit legal entity or non-profit legal entities established in the EU by manufacturers and marketing authorisation holders of medicinal products bearing the safety features. The competent authorities of the individual EU Member States will have access to the repository system located within their territory for certain purposes such as supervision and monitoring and pharmacovigilance purposes.
APPLICATION AND GUIDANCE
The Delegated Regulation will apply as of 9 February 2019. Belgium, Greece and Italy, however, have the option of deferring the application of the rules by an additional period of up to 6 years.
To facilitate the implementation of the Delegated Regulation, the European Commission has prepared a "Questions and Answers" document. In addition, the regulatory requirements governing the notification to the European Medicines Agency ("EMA") of the new unique identifier and/or the anti-tampering device on centrally authorised products are detailed in an implementation plan.
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.