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FMD: 4 Considerations when planning regulatory submissions
20-07-2018

#FMD: 4 Considerations when planning regulatory submissions

As the deadline for the implementation of the safety features stipulated by the Falsified Medicines Directive (Directive 2011/62/EU) approaches, marketing authorisation holders (MAHs) should have long started preparing for the introduction of the unique identifier (UI), a two-dimensional barcode, and anti-tampering device (ATD) on the outer packaging of their medicinal products. So let’s have a look at the regulatory implications.

By 9 February 2019, all prescription-only medicines, except for those listed in Annex I of Commission Delegated Regulation (EU) 2016/161, and the non-prescription medicines as per Annex II of the same Regulation must bear the safety features for the purpose of authentication, identification, and verification that the packaging has not been tampered with.

The European Medicines Agency (EMA) and Heads of Medicines Agencies (CMDh) have already provided guidance on how to introduce the safety features and the impact thereof on the marketing authorisation dossiers for centrally and nationally (including MRP and DCP) authorised products, respectively. Additional information can also be found on the website of the individual Member States.

This blog post summarises the regulatory requirements for the implementation of the UI and ATD and offers several points regarding the planning of submission that you want to consider.

 


REGULATORY REQUIREMENTS FOR THE UNIQUE IDENTIFIER

In order to facilitate the introduction of the unique identifier (UI), the Quality Review of Documents (QRD) template has been revised to include standard statements in sections 17 and 18 of the labelling of the (outer) packaging. The use of the revised QRD template has been mandatory for ongoing and new marketing authorisation applications since April 2016.

For existing marketing authorisations, any upcoming regulatory procedures affecting the product information should be used. Such procedures may be renewals, line extensions, type IA, type IB or type II variations. The use of a type IA variation to add the standard statements on the UI is only acceptable if there are no other changes to the QRD template. If no regulatory procedures affecting the product information are planned prior to the implementation deadline, an Article 61(3) notification should then be submitted.

 


REGULATORY REQUIREMENTS FOR THE ANTI-TAMPERING DEVICE

As the anti-tampering device (ATD) is to be placed on the outer packaging, it is expected that its implementation will not have any impact on the product information. Should there be no outer packaging, the ATD has to be placed on the immediate packaging. In this case, if it affects the container closure system, the dossier has to be updated and a variation submitted. However, if the placing of the ATD on the immediate packaging does not have any impact on the container closure system, no regulatory action will be necessary. It should be noted that an Article 61(3) notification should be submitted if the ATD interferes with the readability of the information on the immediate packaging.

 


POINTS TO CONSIDER WHEN PLANNING  REGULATORY SUBMISSIONS

  • As type IB and type II variations require prior approval and Article 61(3) notifications need to be concluded before the deadline of 9 February 2019, these submissions should be carefully planned, taking into account the timeline of each regulatory procedure.

  • Considering that type IA variations are “do and tell”, they do not need to be submitted before the deadline for the implementation of the safety features, provided that only the standard statements on the UI are added to the labelling. You could consider to group type IA variations across marketing authorisations.

  • Separate variation applications may be needed for the inclusion of the standard statements on the UI and the update of the dossier for the implementation of the ATD, making the planning of the submissions more complex.

  • A few Member States (Belgium, Greece and Italy) already have a national system for the identification of medicinal products in place. They are allowed to apply a longer transitional period for the implementation of the safety features (Belgium has officially agreed to not use this option). These Member States should be consulted for advice in case of an MRP or DCP due to the disharmonisation of the product information during the transitional period.

 

This list is not exhaustive but can form a general basis for your planning. Since the requirement to implement the safety features can affect the entire portfolio of a company, strategic decisions need to be taken for the efficient and timely handling of the regulatory submissions to ensure compliance with the provisions of the Falsified Medicines Directive and the Delegated Regulation.

Blog by: Tin Choi Lam


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