SYSTEM USERS

MARKETING AUTHORIZATION HOLDERS (MaH's)

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.

USEFULL LINKS

More information is available on the EMVO document’s page which can be found at the following address:

WHOLESALERS

Wholesalers in Cyprus will have to verify the medicinal products in their warehouses, under specific conditions provided for, by the relevant Regulation 161/2016. They may also be required to decommission product codes of prescription medicine which are distributed to doctors, hospitals or prisons.

The wholesalers in Cyprus should adapt their computer systems before the date of application of the Regulation (9 February 2017) by linking them with the repository of the CyMVS.

The participation of wholesalers in the in the CyMVS is free and no annual fees will be implemented.

Pharmacies

Pharmacists, as healthcare professionals, have a very important role to play in the medicines verification system because; they are, by the nature of their profession, the final link in the distribution chain, before a medicinal product reaches its final recipient, the patient.

The pharmacist, when selling the medicinal product, will visibly examine whether the package has been tampered with. Then, using a 2D barcode reader and dedicated software to be installed on the pharmacy’s computer, decommissioning of the unique code will be performed, before delivering the drug to the patient. By implementing this procedure, which lasts only a few milliseconds, the medicinal product will be verified as authentic before, it is dispensed to the patient. The above procedure makes the pharmacy the most suitable location in the distribution chain for the detection of falsified drugs.

Pharmacies in Cyprus should adapt their computerized systems prior to the date of application of the Regulation (9 February 2017) by linking them with the repository of the Cyprus Medicines Verification System.

The participation of pharmacies in the CyMVS is free and no annual fees will be implemented.

Pharmaceutical Services

The Pharmaceutical Services provide secretarial support to the Drugs Council, which is the competent regulatory, decision making body, for the implementation of the Laws and Regulations for pharmaceutical products. The purpose of the Drugs Council and of the Pharmaceutical Services is to ensure the Safety, Quality and Efficacy for all pharmaceutical products marketed in Cyprus and in doing so, to protect Public Health.

The implementation of the Laws and Regulations on pharmaceutical products is achieved, inter alia, by regulating the following:

  • Licensing of Pharmaceuticals,
  • Licensing of Wholesalers,
  • Pharmacovigilance,
  • Advertising,
  • Price setting for Pharmaceuticals,
  • Inspections of wholesalers and manufacturers of pharmaceutical products in Cyprus.

The Drugs Council and the Pharmaceutical Services being the Regulatory Authority in Cyprus for pharmaceuticals will have both a supervisory and a regulatory role to play in the implementation of the legal framework for falsified pharmaceutical products. . It is expected that the cooperation between KOEΦ and the Pharmaceutical Services will be benevolent and continuous, aiming at jointly combating the scourge of falsified medicines and protecting patients.

For more information regarding the Pharmaceutical Services follow the link below:
https://www.moh.gov.cy/moh/phs/phs.nsf/dmlindex_en/dmlindex_en?opendocument