European Commission Revises Q&A on Safety Features for Medicinal Products

Regulatory NewsRegulatory News | 26 November 2018 |  By 

The European Commission on Monday released a revised question and answer document regarding the implementation of the rules on the safety features for medicinal products for human use.

Revisions in the document are related to two questions and answers, including one on if a pack bearing safety features is lawfully opened by, for instance, parallel traders or manufacturers replacing the leaflet, can the pack be resealed? The answer notes that in certain circumstances it can occur, based on the assessment of the national competent authority in the member state.

“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 [anti-tampering device]). 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.

“An anti-tampering device (ATD) placed on top of an older, broken ATD can be considered as effective in providing evidence of tampering as an ATD placed on an intact outer packaging only if: (a) The new ATD completely seals the pack and covers any visible sign of the original, broken ATD; (b) The replacement of the ATD is conducted in accordance with applicable good manufacturing practice for medicinal products and is subject to supervision by the competent authority; and (c) The manufacturer placing the equivalent ATD has verified the authenticity of the unique identifier and the integrity of the ATD on the original pack before breaking the ATD/opening the original pack, in accordance with Article 47a(1)(a) of Directive 2001/83/EC,” the Q&A says.

The other revised question is on whether it’s acceptable to use stickers to place the unique identifier on the outer/immediate packaging.

The EC notes that 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.

“Placing the unique identifier by means of stickers can be accepted 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,” the Q&A says.

In cases where placing the unique identifier by means of stickers is authorized by competent national authorities under such circumstances, the EC notes that the following conditions should be met: “The sticker on which the unique identifier is printed should become one with the outer packaging/immediate packaging, i.e. the sticker should be tamper-evident and it should not be possible to remove it without damaging the packaging or the sticker itself or leaving visible signs; - The sticker on which the unique identifier is printed should be placed by a manufacturer under GMP conditions; and - The outer/immediate packaging on which the sticker is placed includes, in addition to the unique identifier, all applicable labelling requirements as laid down in Article 54 of Directive 2001/83/EC.”

However, the Q&A also warns that placing the unique identifier by means of stickers should never be allowed when: it impairs readability, the sticker on which the unique identifier is printed can be detached from the packaging without damaging the packaging or the sticker itself or leaving visible signs, or the sticker “is intended to be placed on top of an existing sticker, as this could engender confusion and suspicions of tampering.”



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