Safety Features

Instructions for the introduction of safety labels on the packaging of drugs approved by the national procedure


Marketing Authorisation Holders are required to include safety features on the packaging of medicines to come in line with the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015. 

The Delegated Regulation will apply in Malta from the 9th February 2019 (3 years after its publication).

The Regulation sets out a system where the identification and the authentication of medicinal products is guaranteed by an end-to-end verification of all medicinal products bearing the safety features, supplemented by the verification by wholesalers of certain medicinal products at higher risk of falsification. In practice, the authenticity and integrity of the safety features placed on the packaging of a medicinal product at the beginning of the supply chain should be verified at the time the medicinal product is supplied to the public. 

There are two safety features to be placed on the packaging of most prescription medicines and certain non-prescription medicines:

1) a unique identifier (a 2-dimension barcode) and

2) an anti-tampering device (ATD).


The implementation plan for the introduction of the safety features in compliance with the Delegated Commission Regulation (EU) 2016/161 is published on the CMD(h)  website:


The regulatory requirements and deadlines specified in the implementation plan for the introduction of safety labels issued by the CMD (h) are also applicable to medicines authorised through the national procedure in Malta.


New QRD templates for the introduction of the safety features

The new QRD annotated template for the labelling includes the following sections in: Particulars to appear on <the outer packaging> or <the Immediate packaging> if the medicinal product has not outer packaging:



Updated QRD template in track changes is available here:



Are any medicinal products exempt from the above?

Yes, the medicinal products exempt from the above are listed in Annex I of the Regulation located here:


Are any medicinal products not subject to prescription but that should include the safety features above?

Yes, the medicinal products not subject to prescription that shall bear the safety features, referred to in Article 45(2) are listed in Annex II of the Regulation located here:


How can the safety features be introduced? (to be read in conjunction with CMDh and other relevant guidance)

·       The introduction of safety labels can be carried out as part of the authorization procedure, and any post-authorisation procedure including renewals and variations (any type) that change the details of the outer packaging of the medicinal product.  For new marketing authorisation applications for medicinal products which bear the safety features, the updated QRD templates should be used for new applications submitted from April 2016.  For ongoing marketing authorisation applications finalised after 1 April 2016, applicants need to comply with the revised QRD templates.

·        If no regulatory procedure is carried out by 9 February 2019, an article 61(3) notification should be submitted.

·        In the cover letter for a specific procedure, it is necessary to clearly state that the safety features are being introduced as part of that procedure, and track-changed labelling with necessary inclusions in sections 17 and 18 of the QRD template for the labelling must be submitted.

·        Mock-ups are not required to be submitted within regulatory procedures for the introduction of safety features. The Marketing Authorisation Holder is responsible for ensuring that the design is appropriate and that the introduction of safety features does not hinder the legibility of the information that must be indicated on the packaging of the medicinal product.

The EMVO On-Boarding Process:The European Medicines Verification Organisation (EMVO) is circulating a letter of announcement to manufacturers, marketing authorisation holders and parallel traders with information material on how companies are to engage in the on-boarding portal. Further details can be accessed on the following EMVO platform:

More information can be found here:

Q&A document on the Commission website.

The Implementation Plan for Centrally Authorised Products (CAPs) on the European Medicines Agency (EMA) website