2019/02/11

New safety features for medicines | EU

Joana de Sá writes about the unique identifier and na anti-tampering device on their outer packaging that most prescription medicines and some over-the-counter medicinal products for human use supplied in the European Union are required to have.

As of 9 February 2019, most prescription medicines and some over-the-counter medicinal products for human use supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging.

In 2011, the European Union | EU, adopted the Falsified Medicines - Directive 2011/62/EU, of the European Parliament and of the Council, of 8 June 2011, harmonised, pan-European safety and control measures that allow easier identification of falsified medicines, and improve verifications and controls at borders and within the EU.

Diverging authentication mechanisms for medicinal products based on different national or regional traceability requirements may limit the circulation of medicinal products across the Union and increase costs for all players in the supply chain. It is therefore necessary to establish Union-wide rules for the implementation of the safety features for medicinal products for human use, with particular regard to the characteristics and technical specifications of the unique identifier, the modalities for the verification of the safety features, and the establishment and management of the repository system containing information on the safety features.

Falsified medicines are fake medicines that are passed off as real, authorised medicines. As they have not been properly checked for quality, safety and efficacy, as required by strict EU authorisation, they can pose a real risk to your health. As falsified medicines become more sophisticated, the risk of them reaching patients in the EU increases. They represent a serious threat to global health and call for a comprehensive strategy both at European and international level.

This Directive introduced new harmonised, pan-European measures, structured around four pillars:

  • tougher rules on import of active substances;
  • strengthened supply chain and requirements for wholesale distributors;
  • a common, EU-wide logo to identify legal online pharmacies;
  • obligatory safety features (i.e. the unique identifier and an anti-tampering device on the outer packaging of medicines that become mandatory today).


The measures included, are:

  • safety features on prescription medicines;
  • an EU logo to identify legal online pharmacies, tougher rules on the importation of active ingredients, and
  • strengthened record keeping for wholesalers.


The safety features are implemented through a delegate regulation - Commission Deleated Regulation (EU) 2016/161, of 2 October 2015 that, as we say, comes into application today, 9 February 2019, and should only be applied on the packaging of the following medicinal products for human use:

  • medicinal products subject to prescription which are not included in the list set out in Annex I to of Commission Delegated Regulation (EU) 2016/161;
  • medicinal products not subject to prescription included in the list set out in Annex II of Commission Delegated Regulation (EU) 2016/161.
  • medicinal products to which Member States have extended the scope of the unique identifier or the anti-tampering device to in accordance with Article 54a(5) of Directive 2001/83/EC.


The safety features consist of two elements placed on the packaging of a medicinal product: (1) a unique identifier, a unique sequence carried by a two-dimensional barcode allowing the identification and authentication of the individual pack on which it is printed; and (2) a device allowing the verification of whether the packaging of the medicinal product has been tampered with (anti-tampering device).

Note that, medicinal products intended for research and development trials and not yet granted a marketing authorisation are excluded from the rules on the safety features.

The unique identifier and the anti-tampering device on the packaging of the medicines will guarantee medicine authenticity for the benefit of patients, and will strengthen the security of the medicine supply chain, from manufacturers to distributors to pharmacies and hospitals. The inclusion of the product code, the national reimbursement and identification number, the batch number and expiry date in the unique identifier contributes to patient safety by facilitating recall, withdrawal and return procedures and pharmacovigilance in this sector.

‘Unique identifier’ means the safety feature enabling the verification of the authenticity and the identification of an individual pack of a medicinal product; and,‘anti-tampering device’ means the safety feature allowing the verification of whether the packaging of a medicinal product has been tampered with; In order to have a negligible probability that a serial number can be guessed by falsifiers, the serial number should be generated according to specific randomisation rules.

The verification of the authenticity of a unique identifier is not only paramount to the authentication of a medicinal product but also informs the person performing the operation of whether that product is expired, recalled, withdrawn or indicated as stolen. Persons authorised or entitled to supply medicinal products to the public should verify the authenticity and decommission a unique identifier at the time the medicinal product is supplied to the public so to access the most up-to-date information concerning the product and avoid that products which are expired, recalled, withdrawn or indicated as stolen are supplied to the public.

The common logo shall be recognisable throughout the Union, while enabling the identification of the Member State where the online pharmacy/retailer is established.

The logo consists of a national flag in the middle left side of the logo which corresponds to the EU country where the pharmacy or retailer is registered or authorised. Only national flags of EU countries or those of Norway, Iceland and Lichtenstein feature. Therefore, a logo displaying the EU flag, for example, would not be legal. The logo can be trusted only if after selecting, a purchaser is redirected to the entry of that pharmacy on the list of legally operating online pharmacies and retailers registered in that EU country on the national web-page.

To identify a legal online pharmacy, citizens must click on the European logo on the pharmacy webpage to make sure it is on the list of legal online pharmacies in the relevant Member State. Only pharmacies authorised in an EU country can sell medicines to European patients online.

This Regulation sets out a system where the identification and the authentication of medicinal products is guaranteed by an end-to-end verification of all medicinal products bearing the safety features, supplemented by the verification by wholesalers of certain medicinal products at higher risk of falsification.

In practice, the authenticity and integrity of the safety features placed on the packaging of a medicinal product at the beginning of the supply chain should be verified at the time the medicinal product is supplied to the public, although certain derogations may apply. However, medicinal products at higher risk of falsification should be additionally verified by wholesalers throughout the supply chain, to minimise the risk of falsified medicinal products circulating undetected for lengthy periods of time.

The verification of the authenticity of a unique identifier should be performed by comparing that unique identifier with the legitimate unique identifiers stored in a repositories system. When the pack is supplied to the public, or is distributed outside the Union, or in other specific situations, the unique identifier on that pack should be decommissioned in the repositories system so any other pack bearing the same unique identifier could not be successfully verified.

Manufacturers, marketing authorisation holders, wholesalers and persons authorised or entitled to supply medicinal products to the public shall be responsible for any data generated when they interact with the repositories system and stored in the audit trail. They shall only have ownership of and access to those data, with the exception of the information referred to in Article 33(2) and the information on the status of a unique identifier.

Joana de Sá | Partner | Head of Pharmacy and Medicines Economic Unit | joana.sa@pra.pt