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'Safety Features' Concept Paper

In late November 2011, the European Commission published a Concept Paper regarding the safety features that are required by the new Falsified Medicines Directive 2011/62/EU.

The Concept Paper seeks input on four main consultation topics:

1. Characteristics and technical specifications of the unique identifier.
2. Modalities for verifying the safety features.
3. Provisions on the establishment, management and accessibility of the repositories system.
4. Lists containing the medicinal products or product categories which, in the case of prescription medicines, shall not bear the safety features and, in the case of non-prescription medicines, shall bear the safety features.

For topic 1 the Concept Paper gives two options for the safety feature:

1. To allow the manufacturer to decide the technical specification.
2. To achieve a harmonised system through legislation.

Note: the tamper evidence requirement of the Directive can already be left up to the discretion of the manufacturer.

For topic 2 the document asks for comment on the proposed composition of the serialisation number – which as a minimum should contain the manufacturer product code and pack number – and whether any additional information such as batch number or expiry date should be included. The Commission also seeks input on the relative merits of linear barcodes, 2D barcodes and radio frequency identification (RFID) tags, including an assessment of cost benefits. This topic also poses questions regarding the systems to be used to verify the unique identifiers, whether this should be carried out only at the point of dispensing or at additional (either systematic or random) points in the supply chain, i.e. at wholesale distributors.

Topic 3 considers the contentious issue of data ownership and the ‘establishment, management and accessibility’ of the repositories against which verification data is checked, particularly where information of a commercially sensitive nature is concerned. Three policy options are provided for consideration and comment:

1. Leaving it to the stakeholders (e.g. pharmaceutical companies, pharmacists and distributors) to develop systems.
2. Some form of centralised pan-EU repository.
3. The establishment of national governance systems.

Questions are asked about issues of personal data and confidentiality, and the requirement for replacing safety features with ‘equivalent’ features – i.e. another unique identifier – in cases where a product is re-packaged.

In topic 4 the paper looks at the scope of the Directive; i.e. the exclusion of certain categories such as non-prescription medicines from the requirements on the grounds of being at low risk of falsification (the ‘white list’ and ‘black list’ approach). It asks for comment on the best way to measure risk in order to categorise products into the two lists.

Comments on the consultation paper should be submitted by 27 April, 2012.