Requirements regarding safety features for packages for medicinal products

Regarding the introduction of a unique identifier and anti-tampering device on mock-ups for products approved via the national, mutual recognition or decentralised procedure, see below. The requirements do not apply for products approved via the centralised procedure unless otherwise expressly stated.

Labelling text

  • The labelling text must be updated in accordance with the latest QRD template as soon as possible. For products currently without an approved labelling text, a labelling text in accordance with the QRD template must be submitted for approval as soon as possible.
  • Updates of already existing labelling texts can be made in connection with other amendments that affects the product information or as a separate case in accordance with Article 61(3).
  • For products approved via the mutual recognition or decentralised procedure, updates of the labelling text must be made via a common procedure before the Swedish labelling text can be updated.
  • It is recommended that the labelling text is updated according to heading 17 ("2D barcode carrying the unique identifier included") and 18 ("PC, SN") in the latest QRD template before the mock-ups are updated and submitted in accordance with the information below. However, it is also possible to introduce a unique identifier and an anti-tampering device on mock-ups first, and later, when suitable, update the QRD template.
  • For non-marketed products, that are subjects to the requirements of the safety features, the labelling text can be updated according to heading 17 and 18 also after 9th of February 2019.
  • Please note that packages, subject to the requirements of the safety features, cannot be certified for release by a Qualified Person without safety features as of 9th February 2019, i.e. the date specified in the Commission Delegated Regulation (EU) 2016/161*.

The above does not apply to parallel imported medicinal products. No labelling texts exist for these products.

Unique identifier

  • The unique identifier is placed on the outer packaging together with other labelling required for medicinal products in accordance with Article 54 of Directive 2001/83/EC.
  • In case the medicinal product doesn't have an outer package and it's not technically feasible to print the unique identifier directly on the primary package (e.g. on a bottle) the unique identifier can be printed on a label which is permanently attached to the primary package.
  • If the primary package is enclosed by an outer package the unique identifier is printed directly on the outer package. Exceptions from this rule can be granted by the Swedish Medical Products Agency, only for well justified cases, in order to secure the supply for a medicinal product when no other technical solutions exist.
  • The product code and the serial number must be preceded by the headers/prefixes specified in the labelling text document, i.e. "PC" for the product code and "SN" for the serial number. The format of the product code ("GTIN" or "NTIN) is not accepted as header/prefix for the product code.
  • The 2D barcode may contain other information than product code, serial number, batch number and expiry date if the Swedish Medical Products Agency approves it.
  • Current EAN code can still be printed on the package. Please note, however, that the EAN code must comport with the human readable codes and the 2D barcode.
  • Medicinal products having to bear the safety features shall not bear on their packaging, for the purpose of their identification and verification of their authenticity, any other visible 2D barcode than the 2D barcode carrying the unique identifier.
  • Since a few years back the Ministry of Commerce and Industry of India has required that all packages of medicinal products that are manufactured in India and exported from India must bear a unique identifier (track and trace system).

9th of February 2019 these Indian codes are no more accepted on packages for human medicinal products that are released in Sweden or in any other member state of the EU. Please note that the Indian code neither can be stated on packages for human medicinal products, for which safety features are not required according to Commission Delegated Regulation (EU) 2016/161*, e.g. most medicinal products not subject to prescription. Packages from India may be exported to Sweden without bearing the Indian code.

Introduction of the unique identifier for mock-ups submitted as for information only

If adding a unique identifier does not impair readability of other information on current packaging (e.g. reduced text size or modified layout), and no other changes has been made that would require assessment, mock-ups may be submitted as for "information only". The following criteria must be met in order for mock-ups to be submitted as for information only:

  • The human readable product codes and 2D barcode (or only the 2D barcode if the package is small enough*) must not be placed on the front panel of the package.
  • The human readable product codes and 2D barcode (or only the 2D barcode if the package is small enough*) can be placed on a side, top or bottom panel.

- Existing text on the side, top or bottom panel where the human readable product codes and 2D barcode is placed may be removed if the text is already stated on another panel on the package. If the existing text is made up of the batch number and expiry date, it is also acceptable to include this information in the human readable codes next to the 2D barcode.

  • Current EAN code may be removed and replaced by a blank surface when a 2D barcode is introduced.
  • The font size of the existing text must not be reduced.
  • Existing text, layout or images must not be moved or changed in any way other than described above.

Anti-tampering device

  • In case an anti-tampering device is required for a medicinal product it is placed on the outer packaging. If the medicinal product does not have an outer packaging the anti-tampering device must be placed on the primary packaging.
  • The anti-tampering device must not affect the readability, hide information or damage the labelling when opened. The anti-tampering device must be designed so that signs of tampering (opening) are directly evident, i.e. without, for example, the need of removing a lid.
  • Exceptions from the requirement that the labelling must not be damaged when the anti-tampering device is broken (i.e. when the package is opened):

- When the anti-tampering device is broken it is considered acceptable that this may damage the human readable product code and serial number. It is also considered acceptable that the readability of the 2D barcode may be affected when the anti-tampering device is broken if the 2D barcode contains only product code, serial number, batch number and expiry date.

Please note, however, that it is not acceptable that the human readable batch number and expiry date is affected when the anti-tampering device is broken.

  • If no visible changes have been made to mock-ups when the anti-tampering device has been introduced, no mock-ups need to be submitted to the Swedish Medical Products Agency, neither for assessment nor for information only. This option may be relevant for example when the anti-tampering device consists of gluing, of a sticker that matches the colour of the background it covers, or of a transparent, non-reflective, sticker. The sticker must also be without text, logotypes or images.
  • If the only changes made to the mock-ups are dashed lines marking perforations, no mock-ups need to be submitted, neither for assessment nor for information only, provided that the dashed lines are not placed over text or images. However, the next time mock-ups are revised and submitted for assessment, or for information only, the dashed lines marking perforations must be indicated on the mock-ups. Please note, that if an explanatory text or symbol has been added to the perforations, mock-ups must be submitted for assessment.

Parallel imported medicinal products

The rules on the safety features for medicinal products subject to prescription are applicable also for parallel imported and parallel distributed medicinal products.

Parallel imported medicinal products can either be relabelled or be repackaged into a new packaging. In certain circumstances it may be possible to break an existing anti-tampering device for the purpose to relabel, and thereafter reseal the packaging with a new equivalent anti-tampering device. An anti-tampering device can be considered as equivalent only if:

  • the new anti-tampering device completely seals the packaging and covers any visible signs of the original, broken anti-tampering device
  • the replacement of the anti-tampering device is conducted in accordance with applicable good manufacturing practice and
  • the repackager has verified the authenticity of the unique identifier and the integrity of the existing anti-tampering device on the original packaging before opening the packaging. This in accordance with Article 47a of Directive 2001/83/EC.

The question regarding relabelling or repackaging as chosen repackaging method is not expressly regulated. Certain regulations are however of high importance for the assessment. In Articles 18, 24 and 30 of the Commission Delegated Regulation (EU) 2016/161 it is for instance stated that a manufacturer, wholesaler or person authorised or entitled to supply medicinal products to the public is prohibited to release, provide or supply a medicinal product to the market if there are reasons to suspect that the packaging of the medicinal product has been opened or otherwise tampered with.

The existing anti-tampering device on the packaging from the exporting country should allow verification of whether the packaging of the medicinal product has been opened or otherwise tampered with. It should therefore not be possible to break or remove the anti-tampering device without damaging the packaging, or the anti-tampering devise itself, hence leaving visible signs of opening or tampering. Consequently, the possibility for a repackager to break an existing anti-tampering device and solely reseal the packaging with a new anti-tampering device, can in practice be limited. To comply with the requirement that the packaging shall not show any signs of being opened, it may be necessary for the parallel importer to repack the medicinal product into a new packaging provided with safety features.

This is applicable also for parallel distributed medicinal products intended for the Swedish market.

Practical information

  • Mock-ups for information only should be submitted electronically to ric@lakemedelsverket.se. Please specify clearly what the case concerns.
  • When mock-ups do not meet the criteria for submission for information only, they shall be submitted for assessment and approval as a separate case in accordance with Article 61(3) or as a parallel import amendment (for parallel imported medicinal products) to ric@lakemedelsverket.se.
  • Please note that packages, subject to the requirements of the safety features, cannot be released without safety features as of 9th February 2019, i.e. the date specified in the Commission Delegated Regulation (EU) 2016/161*.
  • General questions about serialisation should be sent to registrator@lakemedelsverket.se with clear information on what the question concerns.
  • Questions regarding cases already submitted should be sent to ric@lakemedelsverket.se

*See Commission Delegated Regulation (EU) 2016/161

 
 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information