Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use

Implementation plan for the introduction of the safety features on the packaging of nationally authorised medicinal products for human use

Information for marketing authorisation holders

In February 2016, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human, established by the Heads of Medicines Agencies, prepared the Implementation plan for the introduction of the safety features on the packaging of medicinal products . It contains detailed information for marketing authorisation holders (and applicants) regarding the procedure for the introduction of these safety features. The plan also explains the timelines for implementation.

See contents of the aforementioned plan here (PDF).

As the State Agency of Medicines (SAM) informed before, the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features to appear on medicinal product packaging (Commission Delegated Regulation (EU) 2016/161) that came into force on 29 February 2017 lay down detailed regulations regarding safety features on packaging of medicinal products for human use, including the placing of two safety features, a unique identifier (UI) carried by a 2-D barcode and an anti- tampering device (ATD), on the packaging of the majority of medicinal products for human use. Marketing authorisation holders shall implement the required safety features for the relevant medicinal products by 9 February 2019.

Marketing authorisation applications for medicinal products

For new marketing authorisation applications:

• The revised Quality Review of Documents (QRD) template should be used since April 2016;
• In the case of medicinal products where the ATD is placed on the immediate packaging because there is no outer packaging and the ATD affects the container and its closure system(s), applicants are required to include information on the ATD and how the ATD affects the container and its closure system(s) (sections 3.2.P.2.4 and/or 3.2.P.7 of the Notice to Applicants Volume 2B).

For ongoing marketing authorisation applications (applications submitted for marketing authorisation are being evaluated):

• The applicant should use the revised QRD template or submit information how the safety feature will affect the immediate packaging, and is encouraged to update the information with answers to the questions included in the procedure.

For existing approved marketing authorisations:

Marketing authorisation holders are encouraged to introduce the safety features together with other variations affecting product information or renewal. If no other procedures are required by 9 February 2019, marketing authorisations holders are required to introduce the safety features in accordance with the Notification procedure of Article 61(3) of the Directive 2001/83.

Detailed explanation and CMDh questions and answers (Q&A) are available on the CMDh website (PDF).

The European Medicines Agency and the European Commission have prepared an implementation plan for centrally authorised medicinal products to guide marketing authorisation holders through the regulatory changes necessary to accommodate the new legislative requirements, and the European Commissions has published a Q&A document. The plan is available on the EMA website (PDF).

The latest version of the Q&A document is available on the European Commission website.

The aforementioned safety features have been introduced to ensure authenticity of medicinal products and to strengthen the safety of the supply chain of medicinal products from manufacturers until distributors – pharmacies and hospitals, thus, protecting European citizens from the risk of falsified medicines.