Serialization of medicinal products: last call

In response to the increase of falsified medicinal products entering the supply chain via legal distribution channels, the European Union (EU) established a reinforced legal framework through the adoption of new mechanisms.

Facing such economic and sanitary consequences, the directive 2011/62/EU dated 8 June 2011 - related to the prevention of the insertion of falsified medicinal products on the supply chain and modifying the directive 2001/83/EC that elaborates a community Code for medicinal products, - had identified four pillars in order, for instance, to reinforce controls throughout the EU. 

This directive had also initiated the implementation of the first pillar related to medicinal products’ safety and more specifically of “safety features” [1] that, for instance, “enable wholesale distributors and persons authorised or entitled to supply medicinal products to the public to:

• verify the authenticity of the medicinal product, and
• identify individual packs.” 

It has nevertheless been necessary to wait for the delegated regulation 2016/161 dated 2 October 2015 to be adopted, for concrete measures to be implemented at an EU level. Indeed, the regulation introduced the two following safety features to be implemented on the medicinal products’ packaging to guarantee their authenticity:

• an “anti-tampering device” (ATD)[2] defined as “the safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with”, and
• a “unique identifier” (UI) defined as “the safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product”[3].

Encoded in a two-dimensional barcode generated according to specific randomisation rules, the UI shall be a machine-readable Data Matrix code printed on the product’s packaging. The authenticity verification should be performed by comparing the UI printed on the box to the UI contained in a repository by scanning the medicinal product all along the supply chain (from the manufacture to the public delivery or the distribution outside the UE for instance, after which the UI printed on the packaging should be deactivated in the repository). To be noted, a human-readable format including some data contained in the UI shall also be printed on the packaging.

The medicinal products that are subject to safety features are listed by the regulation appendix (prescription only (annex I) or not (annex II) medicinal products). As regard to EU regulation, medicinal products without a marketing authorization (i.e. medicinal products used in a clinical trial or under temporary authorization of use), as well as medicinal products that are only to be exported, are not subject to safety features[4]. As regard to French regulation, it should be reminded that currently and up until 9 February 2019[5], it is required for a safety feature[6] and an ATD[7] to be printed for instance on reimbursed medicinal products external packaging.

The implementation of such measures - at the latest on 9 February 2019[8] - that are particularly expensive, shall be anticipated by the industry.

[1] Including but not limited to articles 47, 54 point (o) and 54a.
[2] See article 3 of the regulation.
[3] Ibid.
[4] D-G for Health and food safety, Safety features for medicinal products for human use, QUESTIONS AND ANSWERS – document version 9 February 2018.
[5] Decree n°2018-291 dated 20 April 2018 on the supply chain of medicinal products’ safety, Article 1, 1°, c) and Article 1, 2°.
[6] Article R. 5121-138-1 and -2 of the French Public Health Code, Decree n°2012-1562 dated 31 December 2012 on the reinforcement of the supply chain of medicinal products’ safety and to the legal framework of the medicinal products’ online sale, implementing the directive 2011/62/EU.
[7] Article R. 5121-138-3 of the French Public Health Code.
[8] Concerning new medicinal products, the deadline for the unique identifier to be printed on the packaging varies, and concerning medicinal products for which the marketing authorisation was granted before the delegated regulation, the regulation will be applicable after 9 February 2019: Implementation plan for the introduction of the safety features on the packaging of centrally authorized medicinal products for human use, EMA, 29 June 2017.