United States: Revised Guidance On Implementation Of The EU Falsified Medicines Directive

The Falsified Medicines Directive 2011/62/EU (FMD) introduced a new requirement for safety features to appear on the packaging of all prescription-only medicinal products: a unique product identifier and an anti-tampering device (ATD). Commission Delegated Regulation (EU) 2016/161 sets out technical detail around the characteristics of the safety features, how authenticity should be verified and by whom.

With the deadline to demonstrate compliance with the Delegated Regulation fast approaching (9 February 2019), we draw your attention to recent revisions to the "Question and Answers" guidance document (Version 13) published by the European Commission in January 2019, which contains amendments to some previous questions and a number of new Q&As. In particular:

  • New question 1.24 asks which batch number(s) should be encoded in the medicines verification system if a medicinal product carries more than one batch number, such as where a product consists of an active component and a solvent. The answer is that only the batch number of the active substance needs to be encoded.
  • New question 1.25 deals with how packs intended for use as authorised investigational medicinal products or authorised auxiliary medicinal products should be decommissioned.
  • Questions 1.26 and 1.27 deal with specific issues for manufacturers in the Greek and Italian markets, where the rules have been deferred until 2025.
  • New question 1.28 confirms that the FMD does not require direct suppliers to hospitals to provide aggregation services. Suppliers may, however, offer the service on a voluntary basis, provided the safeguards outlined in the Expert Group paper on implementation of the Falsified Medicines Directive in the hospital setting are met.
  • New question 3.6 confirms that a medicine with only one of the safety features (either the unique identifier or an anti-tamper device) that has been released for sale before 9 February 2019 and has not been repackaged or re-labelled may remain on the market until its expiry date. However, new question 8.9 confirms that this transitional measure does not apply in respect of products that were released before 9 February 2019 with a unique identifier. The unique identifiers for such products should be uploaded to the system before the entry into application of the new rules.
  • New question 4.5 explains that manufacturers are required to check that the 2D barcode for the unique identifier is readable and contains the correct information, and to work closely with marketing authorisation holders to ensure that all relevant information on unique identifiers has been uploaded to the repository system before they release medicines for sale or distribution.
  • The guidance in respect of question 5.7 has also been updated to clarify that, if the 2D barcode is damaged or otherwise unreadable, then, provided there is no suspicion of falsification and the authenticity of the product can be verified using the human readable code, the product can be further distributed.

This updated Q&A guidance comes soon after a smaller update in November 2018 (Version 12), which adjusted the responses to questions 1.20 and 2.21:

  • Question 1.20 explains that if the packaging of a medicinal product bearing the required safety features is opened by manufacturers or parallel traders for the purpose of replacing the patient information leaflet, it can be resealed by applying a new anti-tamper device on top of the old, broken anti-tamper device, provided the national competent authority in the destination Member State is satisfied that the new anti-tamper device is "equivalent" to the original.
  • Question 2.21 confirms that, as a general rule, the unique identifier should be printed directly onto the outer/immediate product packaging, but that stickers may be used exceptionally, subject to certain conditions designed to preserve the integrity and readability of the packaging and safety features.

It is clear that this Q&A document is evolving rapidly to address technical concerns being raised by relevant stakeholders; further developments and guidance seem likely as the new safety features regime is rolled out.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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