On Friday 10 July 2026, the European Commission published Version 22 of the Questions & Answers concerning Safety Features for Medicinal Products for Human Use. The new version does not introduce new obligations. It does, however, amplify the responses to a number of questions and clarify related obligations. Among the most substantial changes are the following:

Question 1.14: Are there any mandatory specifications for the anti-tampering device (ATD)?

The answer to this question is amplified to provide that any anti-tampering device (ATD) must allow verification of whether the packaging of the medicinal product has been tampered with. Consequently:

    • The integrity of the ATD should indicate whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic;
    • It should be possible to demonstrate that, if the ATD is removed or broken, this is evident visually from the pack. The tamper evident nature should also be proven throughout the shelf life of the medicinal product;
    • The ATD should not break under normal conditions of handling in the supply chain;
    • The quantity and quality of the materials used for the ATD and the packaging should be appropriate to ensure the effectiveness of the anti-tampering feature;
    • Manufacturers are invited to consider standard EN ISO 21976:2020 “Packaging – Tamper verification features for medicinal product packaging”.

Question 1.22: In case of parallel-traded packs, can parallel traders cover or remove the safety features of the original pack?

    • Where parallel traders cover or remove existing safety features, they must replace these with equivalent safety features. The new unique identifier should comply with the requirements of the EU Member State where the medicinal product is intended to be placed on the market;
    • If the product code and/or batch number of the parallel-traded product change compared to the original product, parallel traders must place a new unique identifier after first decommissioning the original one;
    • In all cases, traceability must be maintained in the repository system in accordance with Article 35(4).

Question 2.3. Is it possible to keep one-dimensional barcodes on the packaging of medicinal products for human use having to bear the safety features, when adding the two-dimensional barcode carrying the unique identifier?

There is a small, but important addition to the response. It is possible to retain both a one-dimensional and two-dimensional barcode. While both barcodes are permitted provided these do not negatively impact the legibility of the outer packaging, an additional requirement has been added. This is that, in addition to the obligation that the barcodes must not be placed in proximity to each other, they, should, preferably appear on different sides of the packaging.

2.7. Question: Is it compulsory to print the national reimbursement number in human-readable format?

Again, a small but important addition is added to the response to this question. The national reimbursement number or other national number should be printed in human readable format only if required by the national competent authorities of the relevant EU Member State and not printed elsewhere on the packaging. It should be printed adjacent to the two-dimensional barcode if the dimensions of the packaging allow it, unless national legislation provides otherwise.

2.21. Question: Is it acceptable to use stickers to place the unique identifier on the outer/immediate packaging of products?

As a rule, the unique identifier must be printed on the packaging.

For medicinal products subject to parallel import and parallel distribution it is possible to use a sticker (adhesive label) provided that the sticker cannot be removed without being damaged and that the sticker fulfils the quality of the printing requirements set out in Article 6 of the Commission Delegated Regulation (EU) 2016/161.

For medicinal products other than those subject to parallel import and parallel distribution, placing the unique identifier by means of stickers can be accepted in the following circumstances:

    • No legal and/or technically feasible alternative exists; or
    • Competent authorities authorise it due to the marketing authorisation to safeguard public health and ensure continued supply;
    • The sticker should be tamper-evident;
    • The unique identifier should not be printed on a separate sticker to the other labelling particulars unless agreed with the competent authority.

Queston 2.21 provides expanded and detailed guidance on stickers carrying the unique identifier

The response distinguishes between parallel traded and all other medicinal products. In particular:

It distinguishes between:

    • parallel-traded medicinal products;
    • all other medicinal products; and
    • specifies when stickers may be accepted, including:
    • where no technically feasible alternative exists;
    • competent authority approval;
    • compliance with GMP;
    • tamper-evident properties;
    • preservation of other labelling.

Question 7.21 Should NCAs have access to all end-user information in the audit trail, including the names and addresses of end-users in another Member State?

Yes, all National Competent Authorities (NCAs) must be given full access to all audit trail data upon request. This includes information such as the corporate name and address of wholesalers and persons authorised or entitled to supply medicinal products to the public, who are involved in verifying the authenticity and decommissioning of a unique identifier.

Deleted Questions and Answers relate largely to transitional periods that have expired.