The European Commission will shortly adopt legislation on the “Unique Identifier” and safety features that manufacturers will have to apply to almost every pack of prescription medicine sold in Europe. This new legislation will be brought in under the Falsified Medicines Directive.
The full name of the Falsified Medicines Directive is Directive 2011/62/EU of 8 June 2011 amending Directive 2001/83/EC (on the Community code relating to medicinal products for human use), as regards the prevention of the entry into the legal supply chain of falsified medicinal products (“the Directive”).
The Directive came into effect on 2 January 2013 and European Union Member States had until that date to implement it into national law. The measures for implementation into national law and the status of those measures can be found on the EUR-Lex website.
One of the most important aspects of the Directive is the introduction of a Unique Identifier. The objective of the Unique Identifier is to simplify the identification of falsified medicines or stolen products illegally entering the supply chain. The proposed technical specification of the Unique Identifier is set out in a Commission Delegated Regulation supplementing Directive 2001/83/EC of the European Parliament and of the Council. The Delegated Regulation sets out comprehensive rules relating to the safety features which must be displayed on the outer packaging of medicinal products intended for human use.
The legislation has been adopted by the European Commission. The legislation will now go to the European Parliament and the Council of the EU (member state ministers) for approval. The two bodies will have two months to approve or reject the legislation. If approved, it should be published in early 2016.
If it is approved, manufacturers will then have three years in which to comply with the requirements. This is extended to nine years for Italy, Belgium and Greece as they are the countries in the EU with existing drug tracing laws). Accordingly, the Unique Identifier will probably need to start being placed on packaging by late 2018.
The Delegated Regulation applies to medicinal products:
- subject to prescriptions that bear safety features under Article 54a(1) of the Directive except those set out in Annex I of the Regulation;
- not subject to prescription, but included in Annex II of the Regulation; and
- to which member states have extended the scope of application of the unique identifier or of the anti-tampering device in accordance with Article 54a(5) of Directive 2001/83/EC.
Specifications of the Unique Identifier and Safety Feature
The draft of the Delegated Regulation requires the Unique Identifier to be on the packaging. It will contain a unique sequence of alphanumeric characters incorporating the following:
- product code (identifying common name, pharmaceutical form, strength, package size and type;
- serial number (sequence of no more than 20 characters produced by a randomization algorithm;
- batch number; and
- expiry date.
Manufacturers are to encode the Unique Identifier in a two-dimensional barcode that is to be a machine-readable Data Matrix to a specific standard. The Unique Identifier and a tamper-proof device will together create a new safety feature that must appear on product packs. When encoded in the Data Matrix as an element of the Unique Identifier, the product code is to be less that 50 characters, globally unique and compliant with global standards.
Obligations to Verify
Manufacturers, wholesalers and persons authorised or entitled to supply to the public will be required to verify the authenticity of the Unique Identifier and the integrity of the tamper-proof device. They will also be required to cross-check the Unique Identifier against a database (repositories system) and manufacturers will be required to keep records.
A repositories system is to be set up by a non-profit(s) established in the EU by manufacturers and marketing authorisation holders (MAH’s). Wholesalers and persons authorised or entitled to supply can participate in the system. The costs are to be borne by the manufacturers.
The system is to be composed of a central information and data router (hub) and national or supranational repositories that are to be connected to the hub. The system is to enable verification of authenticity and identification and decommissioning of any individual pack.
The MAH’s or, for parallel imported products, the person responsible for placing the medicinal products on the market will have to upload the information before the medicinal product is released for sale. The minimum information to be loaded onto the system is listed in the legislation as:
- data elements of Unique Identifier (as set out above);
- coding scheme of the product code;
- name and common name of the medicinal product, pharmaceutical form, strength, package type and size of the medicinal product;
- Member States where the medicinal product is intended to be placed on the market;
- where applicable, code identifying the medicinal product in the database referred to in Regulation (EU) No 726/2004;
- name and address of the manufacturer;
- name and address of the MAH; and
- a list of wholesalers designated by the MAH by written contract to store and distribute the products.
Obligations of MAH’s, Parallel Importers and Parallel Distributors
Again, under the draft legislation MAH’s, parallel importers and parallel distributors will have to ensure:
- decommissioning of the Unique Identifier for a medicinal product that is to be recalled or withdrawn in every repository covering the relevant member state;
- decommissioning of the Unique Identifier for stolen products;
- decommissioning is indicated in the repositories; and
- any free samples are to be indicated as such.
If the Delegated Regulation is affirmed, then the coverage and requirements outlined above will come into law and stakeholders in the industry will have a limited, but reasonable, time in which to adapt to the requirements. Initially it will impose significant costs and obligations on the industry. In the longer-term there are likely to be benefits from a reduction in fake medicines entering the market and the ability to target re-calls of products.