Safety features
Introduction of safety features in the medicinal products for human use on the Finnish markets
Safety features have to be introduced in packaging of human medicinal products on the Finnish market as required in the Delegated Regulation of the European Commission (article 50 (EU) 2016/161) no later than 9th February 2019.
Safety features consist of a package-specific unique identifier (2D-code and its human readable format) enabling the verification of the authenticity and identification of an individual package, as well as an anti-tampering device allowing the verification of whether the packaging of a medicinal product has been tampered with.
The Delegated Regulation of European Commission can be found on the Commission webpages.
All medicinal products subject to prescription shall bear the safety features, except for those medicinal products which have been listed in the Annex 1 of the Delegated Regulation.
Medicinal products not subject to prescription shall bear the safety features only if medicinal product or a group of the medicinal products have been mentioned in the Annex 2 of the Delegated Regulation. Medicinal products mentioned in the Annex 2 and to be placed on the Finnish markets shall bear safety features no later than 9th February 2019.
Each Member State of the European Union decides independently if the unique identifier or an anti-tampering device is to be placed on the packaging of medicinal products other than mentioned above.
Introduction of a unique identifier on the package label
The package labelling can be updated in connection with a variation application that concerns the product information, or as part of a renewal of a marketing authorisation for a medicinal product or as a separate 90-day notification (Notification pursuant to Article 61(3)) in accordance with the CMDh implementation plan.
Marketing authorisations approved via mutual recognition or decentralised procedure
The harmonised QRD-texts should be updated by an application submitted via a common mutual recognition procedure in accordance with the CMDh implementation plan. The mock-ups may be updated in connection with this application or the changes may be implemented on the mock-ups later so that the packages contain the unique identifier in accordance with the Commission Delegated Regulation (EU) 2016/161.
Marketing authorisations approved via national procedure
The QRD-texts are not updated.
All marketing authorisations
The unique identifier may be added on the mock-ups without a separate 90-day notification when the following conditions are fulfilled:
- The 2D-code and the human readable information (or 2D-code only if the package is sufficiently small) is not positioned on the front of the package. Existing text on the side panel where the above information is located may be removed on the condition that it is already printed on another panel on the package or if it is included in the human readable information of the 2D-code (such as batch, expiry date). Texts should not be moved.
- The font size of existing information text must not be changed.
- Existing texts, images and/or layout is not moved or modified. EAN 13 barcode, with unchanged location, may remain on the package. Note that the product code in the EAN 13 barcode must correspond with the product code in the unique identifier.
When the conditions above are not fulfilled and changes are required to be made in the mock-ups, the proposals for the mock-ups should be submitted to Fimea via a 90-day notification.
The updates of the product information may be submitted to Fimea continuously during the ongoing transition period. The changes of the packages should be implemented on the released product batches no later than 9 February 2019 (Article 50 (EU) 2016/161).
Introduction of an anti-tampering device (ATD) on the package
The anti-tampering device (ATD) may be placed on the outer packaging without a separate notification when the addition does not affect the layout of the label. When the addition of the ATD changes the layout of the label, the mock-ups should be submitted to Fimea via a 90-day notification.
When the ATD is placed on the immediate packaging of the medicinal product, the information should be updated in the quality part of the dossier (Module 3, 3.2.P.2.4 and 3.2.P.7) submitted as a type B.II.e.1 variation application in accordance with the CMDh implementation plan.
The ATD may be placed also on the packaging of the medicinal products without a prescription; however, for them the applicant should send Fimea an e-mail notification to address [email protected], with a subject “Anti-tampering device”. The e-mail notification should clearly identify the medicinal product (product name, strength and dosage form) and the concerned package sizes.
General questions about safety features should be sent to [email protected] with clear information on what the question concerns.