Market Authorization Holders
Marketing Authorization Holders (MAH’s)
as key stakeholders and financiers of the computerized medicines verification system are required to play a very important social role in protecting Public Health.
The unified computerized system that will be mandatory in all countries of the European Economic Area will allow authentication of medicinal products that are dispensed to patients by preventing falsified medicines from intruding in the legal delivery chain.
From 8 February 2019 onwards, MAH’s supplying prescription medicines on the Cyprus market should ensure that all commercially available packaging meets the safety requirements set out in Regulation 161/2016 (two-dimensional code data matrix containing, amongst other information, the unique alphanumeric code for each package and a mechanism enabling the detection of falsification on the packaging). It is expected that a large number of MAH’s will start marketing their products, meeting the above requirements, much earlier than 9/2/2019.
The most important steps to comply with the new requirements are:
- Diversification of the packaging with the introduction of the above mentioned security provisions and obtaining of the relevant approval by the Pharmaceutical Services,
- Upgrading production facilities to allow the introduction of the 2D code and safety mechanisms onto the packaging of prescription medicines,
- Participation in a single EU database operated by the European Medicines Agency (EMVO),
- Transfer of unique packaging data to the EMVO repository after the ΜΑΗ has been registered as OBP (On Boarding Partner). These data will then be forwarded to the National Repositories (CyMVS in the case of Cyprus) where these packs are intended to be placed on the market,
- Registration to KOEΦ and payment of the corresponding registration fee. In addition, there will be a fee to be paid on an annual basis.
More information is available on the EMVO document’s page which can be found at the following address: