Regulatory measures through the new Counterfeiting Directive

From 09 February 2019, medicines subject to verification may only be released for sale or distribution if they have the new security features, on the one hand the unique identifier and on the other a device on the packaging against manipulation (“anti-tampering device”). With the introduction of the new security features, the identity and authenticity of each individual drug is to be checked in order to identify counterfeit products from the legal supply chain. In this context, the basic conditions for the approval departments are also changing.

Legal basis

The Counterfeiting Directive from 2011 has been extended by technical and organizational details regarding the security features. On February 9, 2016, Regulation (EU) 2016/161 was published in the Official Journal of the European Union and must be implemented by all pharmaceutical companies within three years of that date. In addition, regulations on safety features in the German Medicines Act § 10 Paragraph 1c and in Article 54a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use were amended.

The unique identifier

In future, an individual Data Matrix code will have to be printed on each outer packaging for machine reading. This will ensure that the medicinal product comes from the lawful manufacturer. The barcode shall include at least the product code (GTIN/NTIN/PPN), the serial number, the batch number, the expiry date and, if required, the national reimbursement number or another national number in accordance with Article 4 of the delegated Regulation. The manufacturer may also include further information in the barcode if the competent authority so permits. In order not to create confusion as to which barcode is to be read for the purposes of authentication and identification, only one two-dimensional barcode is allowed on each package. In addition to the barcode, the product number, serial number and, if required, the national reimbursement number or other national number shall be indicated in plain text on the packaging.
Due to the additional identifying features on the outer packaging, the EMA has added points 17 (“Individual identifier – 2D barcode”) and 18 (“Individual identifier – human readable format”) to the Labelling section of the QRD template for product information texts. Pharmaceutical companies are thus obliged to report their updates to the authorities in accordance with the new QRD template. This change can be submitted with any regulatory process (variation regarding information texts, renewal or extension). If no suitable regulatory process is pending, the template update will be requested from the competent authority in accordance with Article 61(3) 2001/83/EC. It is important that the competent authorities are informed before 09 February 2019. Furthermore, the submission of the template update is not dependent on the actual attachment of the security features to the packaging or vice versa. The submission itself is only a kind of declaration of intent that the application of the security features will be implemented by 09 February 2019. In addition, it should be noted that the product information for medicinal products that are not subject to verification must also be adjusted by points 17 and 18, whereby only the reference “not applicable” is included in both sections. However, the transitional period is irrelevant for these medicinal products, as it does not result in any changes to the labelling.

The anti-tampering device

With the device on the outer casing, everyone should be able to see whether it has been opened or changed since manufacture. The definition of features for checking manipulations is regulated in the CEN standard DIN EN 166679: 2015-03.
Different methods are available for this purpose. The folding box could, for example, be closed with perforation, a film wrapping, blisters, cuffs or sealing labels or tapes.

If the device against manipulation does not impair the container and its sealing system or is placed on the outer packaging, no regulatory procedure is necessary.

Which medicines need the safety features?

Article 54a(1) of Directive 2001/83/EC requires that prescription-only medicinal products must bear the safety features, while non-prescription medicinal products must not bear the safety features (unless they appear on the list with a risk of counterfeiting, see Article 54a(2)(b) of Directive 2001/83/EC). As regards samples of medicinal products, Article 41 of the delegated Regulation (EU) 2016/161 supplementing Directive 2001/83/EC contains the following information: A marketing authorisation holder intending to supply as a free sample in accordance with Article 96 of Directive 2001/83/EC one of his medicinal products bearing the safety features shall mark that medicinal product in the data storage and retrieval system as a free sample and ensure that the individual identifier is deactivated before the medicinal product is supplied to persons authorised to prescribe it.

What happens to medicines without security features already on the market?

According to Article 48 of Regulation (EU) 2016/161, all released medicinal products placed on the market before 09.02.2019 may be released to the public until their expiry date.

Technical implementation with the verification system

A National Medicine Verification Organisation (NMVO) is set up in each EU member state, which is responsible for the system handling of authentication. In Germany, this is done by securPharm e.V. with its technical verification system of the same name for authentication. The serial numbers are transmitted to the verification system and stored there before they are placed on the market. Before being released to the public, the barcode is scanned onto the pharmaceutical packaging and checked in the national verification system. The system indicates whether it is the original or a counterfeit. When the original is delivered, it is cleared from the system.

With the new legal requirements for counterfeit protection, a good starting condition has been created for combating drug counterfeiting. The challenge now lies with the pharmaceutical companies and all those involved to meet the requirements of the Anti-Counterfeiting Directive and the Delegated Ordinance on time, especially with regard to regulations. The fact is that as of February 9, 2019, no drugs requiring verification may be placed on the market without an individual identifier and tamper protection. This process is also a major hurdle for the approval authorities, as they have to deal with the flood of mass applications without endangering the supply of medicines in the European Union.