Bucharest, February 7th, 2019 – The Romanian Organization for Serializing Medicines (OSMR), marks today, in Bucharest, during the press conference: „Patient Safety through Medicines Safety”, the fact that in two days the National Medicines Verification System (NMVS) becomes operational in Romania, providing patients, as well as all those who are part of the production and supply chain, safe access to non-falsified medicines.
Falsifying medicines is a major problem at EU level. According to the European Commission, during the period: 2013 – 2017 alone, there were at least 400 medicines falsification incidents reported.
“The purpose of this system is to function as an integrated and interconnected platform through which each medicines pack released in the European Union and the European Economic Area is verified so as not to be falsified when released to the patient. National systems are connected through the European Hub and between them, providing thus an increased level of patient safety “ has stated Dan Zaharescu, President of the Romanian Organization for Serializing Medicines (OSMR), responsible for the implementation and management of the System in Romania.
Starting with February 9th, 2019, according to the provisions of the Directive 2011/62 and the Delegated Regulation 2016/161, the European Medicines Verification System (EMVS) becomes operational in the Member States of the European Union and the European Economic Area, and from this date onwards, only medicines which comply with the new safety rules may be put into circulation. Serializing envisages medicinal products subject to prescription as well as a medicinal product not subject to prescription whose active substance is omeprazole.
Attending the event, Octavian Alexandrescu, State Secretary in the Ministry of Health, restated the importance of this moment in the context in which Romania holds the rotating presidency of the European Union Council and firmly assured that support will be provided regarding the identification of those aspects which need to be regulated.
“The Ministry of Health provides permanent support to promoting the necessary legislative acts, so that the entire supply chain, from manufacturers to the open or closed-circuit pharmacies, can be aligned with the new European provisions. Two new normative acts have been developed, creating thus the framework for the implementation of the Delegated Regulation, namely: Order no. 985/2018 and Order no. 1347/2018. Additionally, in order to emphasize the obligation to comply with the legal provisions and to ensure that all the entities align to these, a draft normative act is being developed to create the sanctioning legal framework and will be promoted in the following period,” has stated Octavian Alexandrescu.
As a result of a multi-year effort, “The European Medicines Verification System (EMVS) is a project unique world-wide, both in complexity and purpose, as well as in the finding and operating mode, the latter being exclusively the responsibility of private, non-governmental entities, which bring together the main actors of the pharmaceutical industry, namely manufacturers, distributors and pharmacists”, has pointed out Laurenţiu Mihai, OSMR General Manager.
The President of the National Agency for Medicines and Medical Devices (ANMDM), Marius Daniel Şişu said that the “Agency has the obligation to oversee the System’s implementation process and, since last year, has been present in the working groups, providing answers to frequently asked questions on the implementation requirements regarding the safety features on the medicinal products packaging.”
The verification is carried out by the scanning done by the pharmacist of the two-dimensional code printed on each medicinal product pack, an operation whereby the encoded information is compared to the one uploaded by the manufacturer in the European database.
The safety features which can be found on the medicinal products packs are:
– The Unique Identifier (two-dimensional code), enables the verification of the authenticity and the identification of an individual pack of a medicinal product, including the following elements: product code; batch number; expiry date; serial number – a numeric or alphanumeric sequence of maximum 20 characters;
– Anti-tempering device is the safety feature which does not allow the unauthorized opening of the medicinal product pack. The anti-tampering device has to be placed on the packaging in such a way that, after tearing it, the information related to the batch number and expiry date remain visible.
Alongside officials, more than 80 representatives of the medicinal products manufacturers, distributors and pharmacies were present at the conference organized today by the Organization for Serializing Medicines (OSMR).