Romania has entered the straight line in the process of implementing the European Medicines Verification System
09.02.2018 Bucharest – “Today the process of implementing the European Medicines Verification System has been officially launched in Romania, a system that will become operational in all EU countries starting with February 9, 2019. As of this date, only the medicines that comply with the new safety rules may be put into circulation within the European Union. The serialization of medicines is an essential initiative for the safety and health of patients, given that the danger of entry of falsified medicines into the commercial chain is increasing. This is the first European directive whose implementation and financing are 100% the responsibility of the private sector and the pharmaceutical industry, ”said Dan ZAHARESCU, President of the Medicines Serialization Organization of Romania (OSMR) and Executive Director of ARPIM, at the National Conference Patient Safety through Medicines Safety – 1 year until the National Medicines Verification System is operational.
The event marked the official launch of the system implementation process in Romania and confirmed the firm commitment of all parties involved in the implementation of the new legislation, from the representatives of the pharmaceutical industry, to the authorities directly involved, such as the Ministry of Health and the National Agency for Medicines and Medical Devices. The present authorities have undertaken to ensure the completion of the national project within the established deadline and to offer all the support to OSMR in order to implement the system under the best conditions.
Mrs. Diana Loreta PĂUN, State Counselor in the Department of Public Health within the Presidential Administration and Mrs. Melania Gabriela CIOT, Secretary of State within the Ministry of Foreign Affairs, underlined that the process of implementation of the National Medicines Verification System is extremely important, in the context in which Romania will hold the presidency of the EU Council in 2019, which implies an even greater responsibility for our country, which goes beyond the local area and extends to the European level. Dr. Florin BUICU, President of the Committee on Health and Family of the Chamber of Deputies drew attention to the fact that we are facing an extremely busy year, that there are many things to do in a short time and that is why it is important that today’s debate to generate a plan outlining the steps we have to take very clearly.
The current state of implementation at the European Union level and the efforts of coordination and supervision by the authorities were presented by His Excellency Mr. Cristian BUCHIU, Deputy Head of the Representation of the European Commission in Bucharest, and the presentation of the technical details regarding the implementation at European level was made by Andreas WALTER, Director General of EMVO – European Medicines Verification Organization and Mrs. Ulrike KREYSA, First Vice President of Healthcare of GS1 Global, the global standardization organization that facilitates the implementation of unique global identifiers and two-dimensional bar code symbology, Data Matrix ECC 200.
“Marketing authorization holders and manufacturers are required to produce the medicines covered by the new legislation with two safety elements that must be checked before being released to the patient: a unique identifier that allows authentication of the individual packaging on which it is printed and a protection device against illicit modifications, which allows verification of the physical integrity of the packaging and can highlight any attempt to modify it unlawfully ”, explained Alexandru CHETRUȘCĂ, Project Manager Arvato, the company that will be responsible for the implementation of the national module in Romania, which will be an integral part of the European Medicines Verification System.
“The implementation of the National Medicines Verification System involves the following steps, which are mandatory: clarifying the national regulations necessary for manufacturers to start the transition to new packaging and to successfully ensure the transition period in the market to the new rules, introduced through the Hub European in the national module of data on medicines to be issued to Romanian patients and clarification of the national rules necessary for organizations involved in the distribution and delivery of medicines to patients, in order to know who, when and how to perform system checks and physical inspections of packaging ”, continued Alexandru CHETRUȘCĂ.
EU Delegated Regulation no. 2016/161 stipulates the obligation to introduce safety elements on prescription medicines and on certain non-prescription medicines, mentioned by them
Dan Zaharescu – OSMR President
“While such a process of verification might seem trivial in the era we live in, it represents a challenge for the pharmaceutical industry, requiring the coordination of all stakeholders in the European pharmaceutical market in a concerted effort to create a European Medicines Verification System, which is then replicated at the level of each Member State and with which it continues to interact.”
Dr. Diana Loreta Păun – State Counselor – Public Health Department – Presidential Administration
“We are talking about the medicines market, about a supply chain that goes beyond the physical borders of states, so the solution can only be that of cooperation in this area, of harmonizing and using the same safety features used by all Member States for preventing the penetration of falsified medicines into the supply chain, in essence about what the European Medicines Verification System stands for.”
Melania Gabriela Ciot – State Secretary – Ministry of Foreign Affairs
“The subject is a multifaceted one, considering, on one hand the need to ensure a suitable treatment to patients, and on the other hand, the benefits that operating a European Medicines Verification System will generate for all European citizens.
The European health policy is a subject that we are considering as a priority also from the view point of the future Presidency of the European Union Council in the first semester of 2019.”
Dr. Florin Buicu -President of the Health Commission of the Chamber of Deputies
“One year may seem like a long time, but actually, it is not. Following the supply chain, back from the patient, we also need the medicine’s safety. This serialization, applying this unique code for each pack of medicines is actually a tool. I guarantee total openness from the Health Commission of the Chamber of Deputies, and also from the Senate Public Health Commission, through the President LÁSZLÓ Attila, who sends his regards.”
Dr. Alexandru Velicu – ANMDM President
“According to the provisions in force, our institution will adopt and apply the detailed rules for the safety features. ANMDM is committed to actively take part in the Working Groups set-up by the OSMR Board of Directors, where Agency representatives will work closely with representatives of the Ministry of Health, NHHI (National House for Health Insurance), with MAH representatives, representatives of public and private pharmacies, representatives of distributors and medicines importers.”
Lidia Onofrei – Director – Medicines Policy Department and Medical Devices Ministry of Health
“Given the importance of successfully implementing this system, on which patient safety depends on, national authorities will support OSMR in its endeavor to implement the Directive.”
Andreas Walter – General Manager European Medicines Verification Organization (EMVO)
“We need to connect 32 countries, 100 000 distributors; 10,5 billion packs/year which need to be serialized; it’s a big challenge for all stakeholders, but also for the competent national authorities, as they are not only supervising, but they are also stakeholders.”
Cristian Buchiu – Deputy Head of the European Commission Delegation in Romania
„The next critical steps: 2019, of course, it’s just around the corner. Still many things remain to be done. In particular, it is now critical that the NMVO signs a contract with an appropriate IT provider, in order for the national database infrastructure to work and start. Last, but not least, the onboarding of verified users need to be completed as soon as possible. (Users) need to be connected to the databases so that the system can be pilot tested in advance of the date in February 2019.
Everybody’s efforts, industry, pharmacies, hospitals, competent authorities, are needed to make the safety features a success.”
Ulrike Kreysa – First Vice President of GS1 Global- Responsible for Health, First Vice President pf GS1 Global ever since 2004, Ulrike Kreysa was GHX Project Manager, later on becoming Executive Manager of this company.
GS1 is a global organization dedicated to creating and implementing global standards and solutions to improve the efficiency and visibility of the distribution chain across the globe. The GS1 Standards System is the most common and widely used standard system for the distribution chain at a global level.
The Global Standardization Organization has been a strategic European partner for the industry and the regulatory environment in the preparation phase of the legislation and is a strategic partner for the implementation phase through the unique global identifier standards and the DataMatrix ECC 200
“I can’t point out enough that it’s important that the countries are moving forward; we can make 2019 happening with countries which have decisions in time and the stakeholders are working together, but, if the manufactures do not know yet what was decided in their country, it’s really hard for them to move forward.”
Valentin Popescu – Technical and Operations Director, OSMR
”The Romanian authorities, the Ministry of Health, ANMDM, the National Health Insurance House were the first to respond, with empowered persons to represent the institution and its opinion in these Working Groups. This is the agreed method, approved by the OSMR Board of Directors so as to achieve rapid results, in order to be able to work collaboratively and to make consensus-based decisions related to the national implementation, but through the principle of inclusion, each involved entity, each organization has guaranteed access to these Working Groups.”