Safety Features: EU Commission issues Version 12 of Q&As

In less than two months, starting on 9 February 2019, many prescription medicinal products in Europe will have to carry the required safety features. Therefore, the list of Q&As on safety features is continuously revised and supplemented.

Two months after the release of Q&A version 11 on safety features, the European Commission has now released a new version of the list in which it has changed two questions and answers:

Question 1.20: "If a pack bearing the safety features is lawfully opened (e.g. by parallel traders/manufacturers replacing the leaflet under the supervision of national competent authorities), can it be resealed (e.g. by applying a new [...anti-tampering device...] ATD on top of the old, broken ATD)?"

According to the Commission's reply, under certain circumstances the feature may be renewed on the basis of the assessment of the competent national authority in the Member State of destination.

The Commission further clarifies: "Parallel traders/manufacturers that wish to reseal packages must provide the competent authority in the destination Member State with sufficient information to allow an informed assessment of equivalence of the new anti-tampering device (description, explanation, mock-ups, pictures, etc. of both the original and replacement ATD). The newly placed ATD can only be considered equivalent if, inter alia, it is equally effective in enabling the verification of authenticity of the medicinal product and in providing evidence of tampering."

In their further explanation, the Commission defines under what circumstances an ATD located on an older, broken ATD may be as effective as evidence of manipulation as an ATD placed on an intact outer packaging.

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

According to the answer in the document "the unique identifier should be printed on the packaging along with all other information required under article 54 of Directive 2001/83/EC, in accordance with Article 5(3) of Commission Delegated Regulation (EU) 2016/161."

The Commission considers the placement of the unique identifier by means of stickers as acceptable in the following circumstances:

  • "No legal and/or technically feasible alternative exists (e.g. safeguard of trademark rights; glass/plastic immediate packaging without outer packaging; etc.); or 
  • Competent national authorities authorise it due to the marketing authorisation, including for parallel import, or to safeguard public health and ensure continued supply."

But even if, due to these circumstances, the competent national authority has approved the placing of the unique identifier by means of stickers, further conditions must be met. What these conditions are, and under what circumstances the placement of the unique identifier by means of stickers cannot be authorized at all, is clarified in the following explanation.

The Commission's detailed answers to the two questions can be found in Version 12 der Safety Features for Medicinal Products for Human Use.

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