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Serialization, state of the art

Serializzazione e tracciabilità

A webinar held on 8th May took the stock of the situation of the serialization for drug traceability, provided for by Directive 2011/62/EU on falsified medicinal products and Regulation (EU) 2016/161.

Italy has been enjoying a waiver, thanks to the presence of antifraud stickers on drug packs marketed in our market, however the time extension for the implementation of serialization will expire in February 2025 and concerned parties are already evaluating any actions to be taken as well as any procedures to be implemented.

The webinar attempted to recap with the trade associations Farmindustria and Egualia what has been done so far and what must still be done to comply with the European regulations, making available all information currently known.

The difficulties for our country in implementing the norm are actually linked to the presence of a pre-existing tracking, completely absent in the other Member States.

Italy switches to serialization

Therefore, it will be complicated for Italy to switch to serialization from a system that is efficient and tested, and this has prompted our regulatory authorities to a greater attention in order to maintain the level of controls against counterfeiting.

The activities aimed at implementation are managed by the Ministry of Health, currently responsible for drug traceability through the antifraud sticker: contacts are ongoing with Farmindustria/Egualia to harmonize the efforts of institutions and pharmaceutical companies.

The regulations to allow the switch from the antifraud sticker to serialization is still under definition hopefully within May, with any relevant implementing decrees hopefully within June.

Refund Tracking

The most critical aspect of its application is linked to reimbursement tracking, due to the difficulties in including all information of the pack sizes to be reimbursed into the data-matrix used in the European countries that have already implemented the regulation: the distinction based on posology, pharmaceutical form and pack size is in fact a very Italian approach, that seems not to be confirmed in the traceability needs of the other Member States.

In any case, Italian regulatory authorities intend to find a specific way to manage the difference between prescription and non-prescription drugs, and between reimbursed and not reimbursed drugs. The most delicate phase will be the definition of the means to transfer all information currently included in the antifraud sticker into the data-matrix.

One of the proposals on the table is to maintain reimbursement management via the sticker, however manufacturers do not agree to the concomitant and parallel use of data-matrix and sticker. Moreover, the European Union will force us to have only one kind of tracking on each pack: either the antifraud sticker or the data-matrix system.

Because of these criticalities, it seems difficult to meet the deadline provided for the implementation, i.e. February 2025, with a delay currently estimated in further 12 months.

Transition period

Nonetheless, it was confirmed that there will be a transition period, potentially lasting 1 year. Packs already bearing the sticker before the time extension expires can be sold off.

Serialization will concern all medicinal products, including OTCs and SOPs, but for the latter a simplified serial numbering is under discussion. A parallel system is also under design to track hospital drugs.

At regulatory level, it seems an agreement has already been reached with AIFA, by which costless notifications to the Agency will be sufficient for the change of the packs, with no need of submitting dedicated variations.

Moreover, for these implementations, at the level of manufacturing sites, there should be no inspections in case of non essential changes (that is, excluding other changes or revamping).

The role of the IPZS

The future role of the State Printer IPZS, current manufacturer of the antifraud stickers, is also being discussed. This will certainly continue to manufacture the stickers for the drugs manufactured on manufacturing lines not yet equipped for serialization; they should also become the manager of the internet provider, a sort of link between the NMVO (National Medicines Verification Organization) Italia (the company created between pharmaceutical companies to manage the serialization) and the European hub.

Speakers were asked questions at the end of the webinar, including those regarding practical aspects, such as the presence of the price, that will not be included in the data-matrix but will be imprinted as already occurs, and special wording like “Free Sample”, for which nothing has been yet defined.

As for the most impacting aspect for industry, i.e. the economic impact, it seems there will be fees charged to MA holders, but with adjustments based on turnovers or sales volumes. Nothing has been decided on this yet.

Di Renzo Regulatory Affairs will keep monitoring the progress of the serialization implementation. We will be back soon with new updates.

Written on 10/05/2024 by Maria Pia Felici