Falsified medicinal products are an increasing problem, which is a threat to patient safety and the pharmaceutical industry. On 9 February 2019, a new verification system will come into force making it possible to verify a medicinal product's authenticity and prevent the flow of falsified medicinal products within the legal supply chain.

The new verification system is a consequence of the new directive on falsified medicinal products (2011/62/EU) and the Commission Delegated Regulation (EU) 2016/161 on supplementary rules for the safety features printed on the packaging of medicinal products for human use.

SPECIAL SAFETY FEATURES MUST PREVENT FALSIFIED MEDICINAL PRODUCTS WITHIN THE LEGAL SUPPLY CHAIN

The purpose of the new rules is to prevent that falsified medicinal products enter the legal supply chain, i.e. the supply chain consisting of players holding a licence under the Medicines Act to manufacture, distribute, sell and pack medicinal products. This includes licensed manufacturers, wholesalers, parallel distributors and pharmacies.

According to the new rules, all prescription-only medicinal products and certain types of non-prescription medicinal products must have special safety features on the packaging:

  • A unique 2D bar code (as opposed to the linear bar code used today) making it possible to identify the specific packaging.
  • A safety sealing making it easy to see if the sealing has been broken.  

In general, the rules apply to all prescription-only medicinal products. However, there are some exemptions, which are listed in appendix 1 to the regulation. The rules also apply to some types of non-prescription medicinal products, which are listed in appendix II to the regulation. Appendices I and II.

DEFINITION OF A FALSIFIED MEDICINAL PRODUCT

In the Directive, a falsified medicinal product is defined as a medicinal product with a false representation of its identity (for instance packaging, labelling, name or composition), its source (for instance holder of the marketing authorisation, manufacturer or country of origin) or its history (for instance records and documents concerning the distribution channels used).

VERIFICATION PROCEDURE

The verification system consists of a European and a Danish database. In February 2015, the European Medicines Verification Organisation (EMVO) was established for the purpose of administering, operating and controlling the European verification system (EU hub/EMVS). However, the Danish database (DMVS) is administered by the Danish Medicine Verification Organisation (DMVO), which was established in November 2016 to ensure the implementation of the new rules in Denmark.

Manufacturers of medicinal products, including manufacturers of original products and generic manufacturers, and parallel importers must add a unique bar code on all packaging. According to the verification system, the manufacturer or the parallel importer then uploads the bar codes’ content to the EMVS, which will then store the information on all packaging sold in the EU. The information is sent from the European database to the national databases.

Pharmacies may not hand out medicinal products to citizens before the products have been verified. The verification takes place in the European database via the national databases as soon as the pharmacy scans the bar code. If the scan shows that the medicinal product has not been sold before or appears somewhere else in the system, the product is genuine and may be handed out to the citizen.

If the product does not appear in the system, or the scan shows that the product has already been sold somewhere else in the EU, it is falsified. The medicinal product may therefore not be handed out and must be handled according to a special procedure.

In order to be able to continue to sell medicinal products after 9 February 2019, the manufacturers and parallel importers must upload their product data to the EMVS and conclude an agreement with the EMVO. If the manufacturers and parallel importers have a marketing authorisation in Denmark, they must be registered and conclude an agreement with the DMVO in order to sell the medicinal products on the Danish market.

MANUFACTURERS AND PARALLEL IMPORTERS MUST PAY A FEE

Manufacturers and parallel importers with marketing authorisations in Denmark that wish to sell their medicinal products on the Danish market must pay an initial fee and a yearly verification fee to the DMVO. The yearly verification fee is a flat fee fixed at European level. The rules governing payment of fees are a consequence of the fact that the establishment and operation of the verification system must be financed by the manufacturers and parallel importers. The fees are to be paid from 2019.

FIVE TIPS ON THE VERIFICATION SYSTEM

  • The manufacturing should already now be prepared for the packagings being provided with bar codes and safety sealings from 19 February 2019.
  • Be aware that the new safety features do not replace the current requirements for labelling etc.
  • The marketing authorisation holders may conclude agreements with the DMVO from September 2017.
  • The safety features may be placed on the packagings prior to February 2019 when the verification system comes into force.
  • The procedure concerning uploading of product data to the EMVS is called On-boarding, and the manufacturers and parallel importers are called On-boarding-Partners (OBPs). For more information on the uploading procedure, see the EMVS' website.

Read more about the Directive

Read more about the regulation

contacts

Anders Valentin

Partner