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
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
For existing marketing
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
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