August 23, 2023
Managing Supply Issues with Labelling Exemptions and Foreign Language Packs at National Level in EU/EEA
It is of utmost importance to ensure that medicines are safe and effective for use by the public. Labelling of medicinal product allows its identification and provides crucial information required for safe and correct handling and administration of the medicinal product. Thus, the requirement to supply medicinal products labelled in national language is integral to patient safety. However, supply difficulties and shortages of medicinal products are becoming a big issue all around the world and both pharmaceutical companies and competent authorities have to search for options to buffer the shortages. In this article, we explore potential pathways and national specificities in obtaining exemptions to labelling requirements in European Union which allow pharmaceutical companies to redistribute stocks in different markets, minimize shortages and ultimately ensure patient access to medicines.
Although according to the WHO, there is no agreed-upon definition of “drug shortages” or “availability of medications” across all of Europe, a shortage generally occurs when supply does not meet demand at a national level. Limited or no availability of medicinal products can cause major problems to individual patients as well as hospitals and even national healthcare systems.
European Union legislation (Article 81 of Directive 2001/83/EC) obliges MAHs, and their distributors, within the limits of their responsibilities, to ensure appropriate and continued supplies to pharmacies and persons authorized or entitled to supply medicinal products so that the needs of patients in the Member State in question are met. In order to be able to notify any interruption of supply to competent authorities, MAHs must continuously monitor the supply and demand situation of their medicinal products and have open and continuous communication with all their operators in the supply chain, such as manufacturers and wholesalers.
The MAH should also be particularly vigilant where it markets medicines for which no or only limited alternatives are available, and where interruption of supply will result in a potential risk to public health and welfare. Essential medications (defined by WHO as those that address a population health need that is of the utmost importance) are meant to be accessible within the framework of operating healthcare systems, with consistent and dependable supplies, in the proper dosage forms, and with guaranteed quality. For those products, on top of standard stock monitoring requirements, competent authorities may require marketing authorization holders to develop a shortage prevention plan, as part of their obligation to ensure continuous supply. Such examples are “Iron stock” in the Netherlands or mandatory supply reserve in Finland. Also, regulatory agencies from across Europe are increasingly collaborating to lessen the effects of shortages on patients.
Shortages of medicinal products are a complex issue which cannot usually be assigned to just one cause or a company. Shortages are often related to production problems, however, the supply of medicines can also be disrupted due to logistical problems, increased demand or commercial reasons. Thus early communication of relevant information is essential in handling shortages and pharmaceutical companies are obliged to inform local Authorities about known and planned supply disruptions. Although not all shortages of medicinal products can be prevented, their impact may be buffered by redistributing stocks intended for other EU markets and bringing foreign language packs into the market under exemptions granted by competent authorities.
The review of exemption requests in case of shortages is generally considered a matter of national recommendation. Some shortages and availability problems are managed at EU level, yet most are managed at national level.
COVID‑19 pandemic is a great example of EU level response. Companies have encountered certain label exemptions and flexibilities, including those involving (possible) treatments and vaccinations for COVID‑19. The main exceptions adopted during the Covid period were the ability to supply medications for emergency usage across EU and in a foreign language in order to address shortages, the adoption of the package leaflet in English with a QR code linking to the product information texts in the national Member States language; temporary exemptions from the Falsified Medicines Directive; a waiver of the requirement for price stickering; the removal of the printed PIL and the provision of English packaging, expedited linguistics reviews, omitted national labelling rules for packaging that uses several languages.
However, as already mentioned, most requests for exemptions to labelling requirements in case of availability problems related to shortages are to be addressed at national level and the decisions are made in the light of the actual shortage situation. Below we share examples of how different Member States address labelling exemption requests to address shortages, including possible supply of packs with labelling in languages of other Member States.
Denmark
The Danish Medicines Agency reviews each individual application. Exemptions permitting the sale of medicines that do not comply with the rules of the executive order on labelling can be granted in special situations, for example, if medicines would otherwise go into short supply, implying that patients cannot continue their medical treatment. The applicant must justify why an exemption is needed and must clearly describe the difference between the present and the new packaging material (for example in table form). Generally, permissions are not granted to sell foreign packages if the medicinal product has not previously been marketed in Denmark.
France
In France, French is always required for labelling of medicines. Limited exceptions have been applied during the covid period for a few life-saving medicines needed for treatment of COVID-19 patients.
Latvia
In situations when a particular medicine in is not available on the national market, it is possible to distribute medicinal product in foreign packaging (intended for market of other European Economic Area State) with added leaflet and sticker in Latvian language.
Lithuania
In case of notified shortage, MAH may request a temporary permission to supply the medicinal product in other EEA language packaging. Each case is individually assessed and permissions are issued for a defined period of time (e.g., for reimbursed medicinal products the validity of permission is tied to reimbursed products pricelist).
Poland
In cases justified by the protection of public health, with serious availability difficulties of a medicinal product, taking into account the safety of the medicinal product, competent authority may for a specified period of time agree to the exemption of the obligation to indicate certain particulars on the packaging and in the package leaflet, or in whole or in part from the obligation to prepare the labelling of the packaging and the package leaflet in Polish. The application should clearly justify thee need for exemption.
The Netherlands
In Netherlands, supply in foreign packaging can be used only as a last resort, (usually for hospital products). Usually, there is a preference for a repackaged product in Dutch.
Sweden
In case of (expected) shortage which is considered a danger to public health if the product is not available on Swedish market, temporary permits to sell medicines in package which does not meet the labelling requirements are an option. This may concern, for example, the supply of medicinal products in packaging which is in foreign language, does not meet the requirements for safety features or that contains an older package leaflet than the last revision.
Conclusion
EU has strict labelling language requirements for medicinal products, but some exemptions are possible under certain circumstances to manage shortages and redistribute stocks across markets with varying acceptance of label exemptions/flexibility across national competent authorities in different EU Members States. However, it must be emphasized that this is only a temporary measure to ensure patient access to medicines. Such exemptions are often confined to a specified time period or batch/quantity and cover the complete package rather than the specific components addressed by the EU flexibilities. MAHs ultimately have to comply with the full labelling and packaging requirements.
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