Patient safety has proven to be a priority at the European level by the passing of the Falsified Medicines Directive in June 2011.
Thus, according to Directive 2011/62/EU of the European Parliament and of the Council, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, prescription medicines need to bear safety features which should allow verification of the authenticity and identification of individual packs, and provide evidence of tampering.
The detailed rules for the safety features appearing on the packaging of medicinal products have been laid out in a Delegated Act – the Commission Delegated Regulation (EU) 2016/161 of 2 October 2015. The safety features consist of a unique identifier that enables the authenticity of the medicinal product to be verified and each individual pack to be identified and an anti-tempering device that allows the verification of whether the packaging of the medicinal product has been tampered with.
Undergoing an extensive preliminary process of preparation, creation, testing, of which Romania, through OSMR, has been a partner since the early stage, starting with February 9th, 2019, a European Medicines Verification System, meaning the EU-Hub and National Medicines Verification Systems (NMVS) have been implemented and are fully functional, allowing the upload, the processing, and the storage of the information on the safety features as well as the verification of the authenticity of the medicines packs and the decommissioning at any point of the legal supply chain.
All stakeholders have understood the extremely important value that this initiative brought for patient safety in Europe and have taken all the necessary steps to abide to the current legislation.
In the application of the Delegated Regulation in Romania, the Ministry of Health Order no. 1,437 of November 22, 2018 was issued as the first important law provision. Manufacturers, pharmacies, wholesalers, parallel distributors, hospital, marketing authorisation holders and software providers are the key actors in the implementation of this complex project at local level and they have all shown great commitment, lots of effort and dedication towards the successful implementation of all the legislative requirements.
The National Competent Authorities have also played a crucial role in the successful project implementation by being open to collaboration and by continuously offering their support in matters falling under their responsibility. One very important document that has been passed by the Romanian Government in the afore-mentioned context is the Ordinance no. 9 of August 8, 2019, for amending and supplementing Law no. 95/2006 on the health reform, as well as for the change and update of some normative acts in the health area, of some regulations regarding the national governmental programs and regarding fiscal-budgetary measures.
Remus Ciuraru, OSMR legal consultant states:
“The involvement of the National Competent Authorities in this challenging endeavour has proven extremely beneficial in consolidating the legislative framework for all parties involved and especially for the patients that are now guaranteed access to authentic medicines.
In Romania there are approx. 11,000 pharmacies, 590 hospitals, 400 wholesalers and 300 MAH registered in the NMVS and approx. 1,270 billion of packs uploaded in the system, portraying thus the large scale of individuals involved and of data being handled.
Close, continuous collaboration with the European Medicines Serialization Organization (EMVO), IT service providers and the corresponding national OSMR organizations in the other European Economic Area (EEA) States also ensures the functionality and continuity of the EMVS and, implicitly, of the NMVS.”