On 12 August 2015, the European Commission notified the World Trade Organisation (“WTO”) of its draft Delegated Regulation 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 outer packaging of medicinal products for human use (hereafter “draft Commission Delegated Regulation”).

Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC, as regards the prevention of the entry into the legal supply chain of falsified medicinal products introduced certain obligatory safety features on the packaging of medicinal products in order to determine their authenticity and impede the distribution of falsified medicinal products. In accordance with Article 54a(2) of the Community Code relating to medicinal products for human use, the European Commission is obliged to adopt delegated acts which are intended to establish rules corresponding to safety features of medicinal products. The current draft Delegated Commission Regulation reflects this requirement.

If the draft Delegated Commission Regulation is adopted in its current form, it would lead to the establishment of detailed rules in relation to the implementation of obligatory safety features for medicinal products that are subject to a marketing authorisation in the European Union (“EU”). Some of these rules are discussed below.

Characteristics and technical specifications of the unique identifier

In accordance with Article 4(1) of the draft Commission Delegated Regulation, manufacturers of medicinal products would be required to place a unique identifier on the packaging of the medicinal product which would reflect certain specific technical specifications. This would include the following information:

  1. product code;
  2. serial number;
  3. national reimbursement number or other national number, where required by the applicable EU Member State;
  4. batch number; and
  5. expiry date.

Article 5(1) of the draft Commission Delegated Regulation specifies that the unique identifier must be encoded in a two-dimensional barcode which is commonly used for industrial and consumer goods. It must, specifically, be a machine-readable Data Matrix. To facilitate the demonstration of compliance with this requirement, manufacturers would be able to rely on international harmonised standard ISO: 16022:2006 concerning “Electrotechnical Commission standard“.

Modalities for the verification of the safety features and decommissioning of the unique identifier

The draft Commission Delegated Regulation establishes a number of verification measures which must be performed by the manufacturer who has placed the safety features on the packaging of the medicinal product. This includes the requirement to ensure that the two-dimensional code carrying the unique identifier is readable and contains the correct information in accordance with Article 14 of the draft Commission Delegated Regulation. The manufacturer will also be required to retain records concerning the placing of the unique identifier on the product for a period of either: (i) one year after the expiry date of the pack of medicinal product; or (ii) five years after the pack of the medicinal product has been released for sale or distribution pursuant to Article 51(3) of Directive 2001/83/EC.

The actions which must be performed by the wholesaler in relation to the verification of the safety features and decommissioning of the unique identifier are also discussed. The circumstances in which a wholesale will be subject to the requirement to verify the authenticity of the unique identifier is addressed in Article 20 of the draft Commission Delegated Regulation. In order to accommodate the different characteristics of the individual EU Member States’ supply chain, verification may be required before supplying the medicinal product to the list of persons and institutions proposed in Article 23.

In addition, certain requirements must be fulfilled by persons authorised or entitled to supply medicinal products to the public. Before engaging in the supply of medicinal products to members of the public, verification of the safety features and the decommissioning of the unique identifier of the medicinal product must take place in accordance with Article 25 of the draft Commission Delegated Regulation.

The Repositories System

The repositories system will be established in order to facilitate the verification of medicinal products in the EU. Once established they 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 and provide access to the competent authorities of the EU Member States upon request.

As proposed in Recital 28 to the draft Commission Delegated Regulation, the repositories system must be “established and managed by the marketing authorisation holders, since they are responsible for placing the product on the market, and by the manufacturers of medicinal products bearing the safety features, since they bear the costs of the repositories system in accordance with Article 54a(2)(e) of Directive 2001/83/EC“.

The competent authorities of the individual EU Member States would be tasked with the supervision of the repositories system located within their territory. Monitoring activities would be communicated to the European Medicines Agency in order to make reporting available to other competent authorities of the EU Member States and the European Commission.

Derogations and notifications to the European Commission

Annex I to the draft Commission Delegated Regulation proposes a list of prescription-only medicinal products that will be exempt from the requirement to demonstrate safety features. Annex II proposes a list of medicinal products that are not subject to prescription but will, nonetheless, be required to demonstrate safety features.

In correlation to the above-mentioned lists, Annexes III and IV to the draft Commission Delegated Regulation also provides notification samples to the European Commission for medicinal products that could be considered by a competent authority of the EU Member States to be either: (a) at risk of falsification; or (b) not at risk of falsification.

Next steps

The European Union is bound by the obligations of the Agreement on Technical Barriers to Trade of the WTO. As part of the notification procedure pursuant to this Agreement, other WTO members will have until 11 October to submit comments in relation to the draft Commission Delegated Act. The proposed date for the adoption of the draft Commission Delegated Regulation is mid-October 2015.

If adopted in its current form, the draft Commission Delegated Regulation would become directly applicable within the EU Member States three years following its publication in the Official Journal of the European Union. Belgium, Greece and Italy would, however, have a transition period of nine years for the application of the Regulation in light of pre-existing measures to verify the authenticity of medicinal products and the identification of individual packs.