The Series of Questions and Answers – Perspectives on Serialisation continues with the point of view of Mr. Virgil Dinulescu, member of the OSMR Board, representative of the Association of Pharmaceutical Distributors and Retailers in Romania (ADRFR).
1. What has been the biggest challenge that serialisation brought in the industry you are representing?
Since the implementation of the Falsified Medicines Directive on February 9th, 2019, the wholesalers have fully complied with their legal obligations, and thus have contributed to the protection of the legal supply chain by preventing the entry of falsified medicines.
Their role is to verify the medicine packs upon reception, for those medicines they receive from a wholesaler who is neither the manufacturer, nor the marketing authorization holder, nor the wholesaler who is designated by the marketing authorisation holder to store or distribute the products on its behalf.
A significant challenge was the change related to the equipment of the working points with the scanners necessary for the medicines’ verification, to the update of the operational flows and to the training of the personnel regarding the level of novelty and complexity of the new activity.
A novelty brought by the serialisation project was the replacement of the linear code, which was not designed to incorporate the amount of information associated with this new unique identifier: product code, batch number, expiration date, serial number, with a new type of code – Data Matrix. Consequently, the new type of code contains all the necessary information for serialisation, it can be printed on smaller packages and it’s flexible, it can adapt to various technical requirements that may appear in the future.
The process of adapting the internal software applications to connect with the National Medicines Verification System (NMVS), was also an extremely important stage in the timely implementation of the provisions of the Falsified Medicines Directive. And of course, the training of the wholesalers regarding the implementation of the new obligations entailed by the serialisation, at national level, was a step that required a lot of effort and a lot of dedication.
2. What is in your opinion the biggest advantage that the Falsified Medicines Directive (FMD) has to offer?
Representatives of the entire pharmaceutical supply chain, together with other relevant actors in this process and with the support of the National Competent Authorities at national level have placed patients’ safety first by implementing the provisions of the Falsified Medicines Directive.
At the same time, the implementation of this Directive has given rise to an ecosystem at European level, the first of its kind, which is based on effective collaboration between all stakeholders and which has as sole purpose the protection of patients’ safety.
Last but not least, the inclusion in the Data Matrix code of relevant data in ensuring traceability of products such as batch number and expiry date, as well as the introduction at national level of a unique code – GTIN – for each product that wholesalers can build on by making current operations more efficient and automated.
3. What have been the major concerns expressed by members within the industry you represent?
The concerns expressed by the wholesalers within the serialisation project implementation focused on the necessary investments in the equipment used, on an open communication with the National Competent Authorities for a successful project implementation and on the integration of the new legislative obligations in the workflow.
Since the beginning, Working Groups have been set up involving representatives from all the sectors impacted by the serialisation, including representatives of the National Competent Authorities and the emphasis has been placed on establishing a transparent and effective communication to facilitate the implementation of the necessary steps for the fulfilment of the legislative obligations regarding serialisation.
4. What are some of the dangers associated with medicines falsification?
Falsified medicines pose a real risk to patients’ health because they do not go through the normal quality and safety assessment required in order to obtain the marketing authorisation at European level.
It is important to take into account the fact that falsified medicines may contain ingredients of lower quality or in incorrect doses, moreover, active substances may be completely absent.
Unauthorised distribution chains that do not comply with the quality requirements set by the manufacturer are also sources that can contribute to reducing the therapeutic impact. These can be identified by verification at various points in the distribution chain and by uniquely identifying scanning points in the verification system.
5.What are the most valuable lessons learned that can be taken by the industry from the serialisation experience so far?
A project of such magnitude and complexity can only be carried out with complete commitment of the stakeholders. This experience of a fruitful collaboration at European level represents an important lesson for wholesalers and an example of cooperation between the parties actively involved in the medicines supply chain – Authorities, medicines’ manufacturers, wholesalers and retailers, moderated by OSMR and the professional associations in the field.
Although there are still things that need to be improved along the way, such as unifying the codification used in prescribing, distribution, reporting and verification of medicinal products, it is clear that any new action that will be successfully implemented must be the result of a joint effort of all actors involved.
At national level, with a number of approximately 400 wholesalers connected to the NMVS, legislative obligations are complied with and all efforts are made to ensure patients’ access to authentic medicines.