Market Authorization Holders

Marketing Authorization Holders (MAH)

MAHs as key stakeholders and funders of the electronic drug verification system are required to play a very important social role in protecting Public Health.

The uniform computerized system that is mandatory in all countries of the European Economic Area allows the authentication of medicines dispensed to patients preventing the intrusion of counterfeit medicines into the legal supply chain.

From 9 February 2025 onwards, each MAH supplying prescription medicines to the Greek market will have to ensure that all commercially available packaging meets the safety requirements set out in Regulation 161/2016 (two-dimensional code data table containing, among others, for each package, combination of product code and serial number and a mechanism that allows detection of tampering in the package). Consequently, MAHs should be able to produce serialized packages earlier than 9/2/2025.

The most important steps to comply with the new requirements are the following:

• Modification of packaging by introducing the safety features mentioned above and receiving the corresponding approval from EOF,
• Upgrading the production facilities to allow the introduction of the two-dimensional code and security mechanisms in the packaging of prescription drugs,
• Participation in a single EU database. operating under the European Medicines Agency (EMVO),
• Transfer of the data of the unique packages to the EMVO repository, after the relevant registration of the MAHs as OBPs (On Boarding Partners). Subsequently, this data will be routed to the National Repositories (HMVS in the case of Greece), that is, to the repository of the country where the packages of the registered medicines are intended to be disposed of.

• See the instructions to register to HMVO here