Impending Regulations on Mandatory Medicinal Product Safety Measures

The complex and multi-player medicinal product distribution system provides ample opportunities to traffickers to enter the supply chain and distribute falsified and dubious origin drugs. In spite of repeated efforts, there has not been any industry wise solution to prevent the market entry of falsified medicinal products into the legal supply and distribution chains. To address this issue, the European Commission prepared a draft Delegated Regulation on the rules of safety features appearing on the outer packaging of human medicinal products (hereinafter: “Regulation”) supplementing Directive 2001/83/EC. The Regulation is intended to create a unique medicinal product safety identifier and a related repository system. The individual identifier shall authenticate the origin of the product and effectively prevent the entry of falsified medicines into the supply and distribution chains.

Scope of the Regulation

The scope of the Regulation shall mandatorily apply to medicinal products subject to prescription with the exception of products listed in Annex I of the Regulation (e.g. medicinal gases, kits, radionuclide precursors), and over-the-counter (non-prescription) medicinal products that are listed in Annex II of the Regulation.

Unique identifier

The Regulation introduces a unique identifier which, according to Article 3(2)1 of the Regulation is a safety feature enabling the verification of the authenticity and the identification of an individual package of a medicinal product. The composition, format and carrier of the unique identifier shall be harmonized across the EU and consist of the following data elements: (i) product code; (ii) serial number; (iii) a national [social or sick fund] reimbursement number; (iv) batch number and (v) expiry date. The unique identifier will have to be encoded by the manufacturer into a two-dimensional barcode that must meet certain technical criteria (e.g. machine-readable; error detection and correction functions).

Verification of the authenticity of the unique identifier ensures that the medicinal product originates from a legitimate manufacturer. Verification obligations are imposed on manufacturers as well as on wholesalers and entities authorized to supply medicinal products to consumers. Manufacturers must verify that the two-dimensional barcode is readable, contains the correct information, and complies with the respective provisions of the Regulation. Manufacturers are also required to keep records of every change that affect the unique identifier for at least one year after the expiry date or five years after the sale or release of the product into distribution.

Pursuant to Article 20 of the Regulation wholesalers must verify the authenticity of the unique identifier of at least on the following medicinal products: (i) medicinal products returned by entities authorized or entitled to supply medicinal products to the public or by another wholesaler; (ii) medicinal products received from a wholesaler that is neither the manufacturer nor the wholesaler holding the marketing authorization, or a wholesaler designated by the marketing authorization holder to store and distribute the products.

The repositories system

The repositories system will be a closed verification system gathering and storing information, inter alia, on the legitimate unique identifiers of medicinal products. Information can be obtained from the system to verify the unique identifier and confirm that it is valid and has not been deleted from the system. The system shall be monitored and supervised by the competent authorities of the EU member states, in Hungary presumably by OGYEI.

The repositories system will be established and managed by the marketing authorization holders and by the manufacturers of medicinal products responsible for the product safety features. Manufacturers will bear the costs of the repositories system pursuant to Article 54a(2)(e) of Directive 2001/83/EC.

Entry into force

The Regulation is open to discussions and comments with a proposed mid-October 2015 adoption date. Once adopted, the Regulation will enter into force in three years following its publication in the Official Journal of the European Union.

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