Safety features of medicinal products

Regulation (EU) 2016/161 on Safety Features

Marketing authorisation holders, holders of wholesale licenses, retail licenses and manufacturers of medicinal products are kindly requested take notice of Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (hereinafter referred to as “the Regulation”).

The Regulation will enter into force on 9 February 2019 and is intended to ensure traceability of packages of medicinal products within the EU/EEA to ensure that falsified medicinal products will not enter the distribution chain and eventually to the patient.

The main scope of the Regulation is twofold. Firstly, all medicinal products subject to prescription shall bear safety features on their packaging (unless included in the list set out in Annex I to the Regulation). Secondly, the Regulation covers the establishment of repository systems covering the entire EU/EEA.

Action required by Icelandic companies

Marketing authorisation holders must ensure that their medicinal products fulfil the requirements stated in the Regulation. The unique identifier (the so-called 2D barcode) and requirements relating to anti-tampering devices must be implemented by 9 February 2019. Furthermore, every entity involved in the distribution chain of medicinal products, responsible for uploading information of decommissioning of medicinal products in accordance with the Regulation must have software linked to the European Medicines Verification Organisation. The implementation of the verification system in Iceland is the responsibility of ICEMVO.

Further information will be provided as required by the Icelandic Medicines Agency, tel. +354 520 2100 or email [email protected]

Update of currently valid marketing authorisations

Information regarding changes in currently valid marketing authorisations, required due to the Regulation are available at the CMDh website. In case of purely nationally authorised medicinal products in dedicated Icelandic packages, the Icelandic Medicines Agency (IMA) does not request updated Labelling documents in relation to the applications; however, updated mock-ups should be submitted with the application. However, based on experience IMA strongly encourages marketing authorisation holders to submit updated labelling documents to ensure that approved Labelling documents will be available when the Regulation on safety features enters into force. In case of multilingual Nordic packages and the country which shares packages with Iceland does not request Labelling documents, IMA will accept the same. In these cases, the changes will be visible in submitted mock-ups cf. above.

As of 24 January 2012 the Icelandic Medicines Agency (IMA) would like to receive final mock-ups of packaging material and package leaflets by e-mail to [email protected]. The same holds for stickers and package leaflets used for repackaging.

The e-mail should contain the following information:

  • Product name, strength, pharmaceutical form, pack size, packaging type and Nordic Article Number (Vnr).
  • Reference to IMA‘s V-number (if relevant) or the marketing authorisation holder‘s application.
  • Article number of the mock-up and reference to the type of material (carton, label, blister, package leaflet etc.).
  • Changes compared to last mock-ups, i.e. if there is no reference to a V-number.

If the mock-ups are submitted by e-mail no hard copies are required nor a formal letter by mail to the IMA.

The IMA plans to confirm receipt of mock-ups by e-mail.

Significant number of medicinal products undergo repackaging in Iceland to fulfil prerequisites of the Icelandic marketing authorisation regarding labelling and package leaflet. The Icelandic Medicines Agency strongly encourages marketing authorisation holders and their local representatives to update these products as soon as possible, to ensure that they fulfil requirements regarding Icelandic labelling and Icelandic package leaflet at the time of final release for the Icelandic market. The goal being to ensure as much as possible that medicinal products will not be withdrawn from the Icelandic market due to the repackaging in Iceland, should repackaging not be a feasible option when the on safety features enters into force.

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