Executive Director European Medicines Agency (EMA)

 

Dear Ms X,

Thank you for the EMA’s reply to my preliminary views on certain issues related to how the EMA handled concerns about the compliance of medicinal products with EU legislation on anti-tampering devices placed on pharmaceutical products.

My inquiry was initially opened to assess whether the EMA had replied to the complainant in this case in line with the principles of good administration, including lawfulness.[1] It is now clear that this complaint raises a broader issue, namely, how the Commission and the EMA ensure proper application of EU legislation on anti-tampering devices placed on pharmaceutical products. The EMA’s position, which is in line with the Commission’s position, is that the efficacy of anti-tampering devices is not verified by the Commission and the EMA within the centralised marketing authorisation procedure. The Commission and the EMA consider that the competent national authorities are the ones responsible for this verification. My inquiry has also raised questions about whether the Commission provides appropriate guidance to these national authorities to enable them to discharge this task. It is not possible to assess the EMA’s replies to the complainant’s notifications of potentially deficient anti-tampering devices without addressing these underlying questions.

Thus, I have decided that it is necessary for my inquiry team to inspect the documents in the possession of the Commission meeting the following criteria:

• the documents relating to the 39th, 40th, 41st, 42nd, 43rd and any subsequent meetings[2] of the Commission’s Expert Group on the Delegated Act on Safety Features for Medicinal Products for Human Use,[3]
• the documents whose subject matter is anti-tampering devices, including their efficacy, the control of this efficacy, regulatory requirements in relation to such devices, and the enforcement of these requirements,
• the documents including, but not limited to:

• comments, questions and submissions from individual members or participants in the above expert group;
• replies and any other material provided by the Commission and the EMA to any questions or submissions within the above expert groups;
• presentations and slides by the Commission, the EMA, and any other EU, national, and non-EU bodies.

In addition, I have decided that it is necessary for my inquiry team to inspect any internal documentation, internal exchanges, and exchanges with members or participants in the above expert group related to drafting and adopting the recent revision of the Commission’s Q&A document concerning the anti-tampering devices.[4]

As the Commission hosts the expert group in question, I have decided to ask the Commission to provide my inquiry team with the above documents. However, should the EMA be in the possession of any additional documents meeting the above criteria, I invite the EMA to liaise with the Commission and provide the additional documents to my Office.

Moreover, given that the Commission is the decision-maker in the centralised marketing authorisation procedure, whereas the EMA plays an advisory role, I have decided it is necessary for my inquiry team to meet with representatives of the Commission to discuss the questions set out in the Annex to this letter. Further questions may be shared based on the results of the inspection.

I invite the EMA’s representatives to take part in such meeting. I have asked the Commission to liaise this EMA to choose an appropriate time for this meeting and inform my inquiry team accordingly.

The inspection of documents should take place by 30 November 2026 and the meeting should take place thereafter, at the latest by 1 February 2027.

I also enclose, for your information, the complainant’s comments on the Commission and EMA’s replies to my preliminary views.

If you have any questions, please contact the responsible inquiries officer, Mr Michał Krajewski.

Yours sincerely,

Teresa Anjinho 
European Ombudsman 

Strasbourg, 30/10/2026 

 

Annex: Questions for the meeting

1) Does the existing legislation, in particular Directive 2011/62/EU (‘the Falsified Medicines Directive’[5]) provide indications as to whether ‘anti-tampering devices’ should be designed in such a way as to protect against criminal acts of falsifying medicines, using external tools or sources of heat?

2) Does the Commission’s Q&A document, following its revision in July 2026, imply that anti-tampering devices do not need to protect against tampering and falsification of medicines for criminal purposes? If so, against what external factors are the anti-tampering devices supposed to protect?

3) How has the Commission considered the objectives of Directive 2011/62/EU (as laid down in its preamble) in revising its Q&A document?

4) Which Member States have supported the revised Q&A document in relation to anti-tampering devices, and which have opposed it, including on what grounds?

5) Does the Commission intend to further harmonise technical requirements for anti-tampering devices and in what way?

6) Does the Commission or EMA have any information, including statistical information, about cases in which national authorities have detected inefficient anti-tampering devices and taken concrete enforcement measures in this regard? Does the Commission or EMA have any other information about how well the current system of anti-tampering devices operates?

 

[1] Article 4 of the European Code of Good Administrative Behaviour, https://www.ombudsman.europa.eu/en/publication/en/3510.

[2] Including those that have not taken place yet but are scheduled or foreseen, in case documents in relation to such feature meetings have already been received or produced by the Commission and/or the EMA.

[3] https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?lang=en&groupId=2719&fromMembers=true&memberType=4&memberId=39295

[4] https://health.ec.europa.eu/document/download/2e49010a-0071-4f39-8b00-c90a266aba76_en

[5] Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, OJ L 174/74, https://eur-lex.europa.eu/eli/dir/2011/62/oj/eng.