Redispensing unused medicinal products under the EU pharma law package

Current framework for unused medicinal products

Under the current EU pharmaceutical legislative framework, there is no harmonised pathway for the redispensing of returned or unused medicinal products. Once a medicinal product has been dispensed to a patient and subsequently returned to a pharmacy, it cannot be redispensed to another patient. Pharmacies are required to dispose of any such products, typically through designated take-back and disposal programmes. This approach has a clear patient safety rationale: once a medicinal product has left the controlled dispensing environment, its integrity – in terms of storage conditions, potential falsification, and physical condition – can no longer be guaranteed.

However, the inability to redispense unused medicinal products is seen as a missed opportunity to mitigate medicine shortages, particularly for medicines with limited availability or complex supply chains. Against this background, article 207(a) of the revised Directive introduces a regulatory framework for the redispensing of unused medicinal products.

Redispensing medicinal products under the EU pharma law package

Under article 207(a) of the revised Directive, the baseline remains a prohibition: medicinal products collected after having been dispensed to a patient shall not, as a general rule, be redispensed to another patient. However, article 207(a) creates an exception, allowing Member States to establish national frameworks under which certain unused prescription-only medicines may be redispensed, subject to several cumulative conditions. A key condition is that the medicinal product must have been initially dispensed with a view of being potentially redispensed, with the dispensing pharmacy having applied the necessary safeguards from the outset to prevent tampering and ensure appropriate storage and transport conditions. Redispensing is therefore not a purely retrospective process; it requires pharmacies to prospectively identify and safeguard eligible products at the point of original dispensing.

The pharmacy that originally dispensed the product must also be the one to collect and redispense it, having sought and obtained authorisation from the competent national authority at its own request. A product may only be redispensed once, the original patient must not be disadvantaged by the collection, and the redispensed product must be assigned to a named patient who has given explicit written consent after being informed of the applicable rules and associated risks.

Before redispensing, the pharmacy must verify that the product is not falsified, has not expired, and has been adequately stored and transported. Detailed records must be kept for traceability purposes, covering the product name, batch number and the identities of both the original and receiving patient.

Member States may impose additional restrictive conditions and must ensure that redispensing is not used for economic gain or to channel medicines back into the broader supply chain. Liability rules must be established for damages arising from failure to ensure appropriate storage or transport conditions, or from redispensing a falsified product. The article expressly does not apply to medicinal products offered through online pharmacies or other ways of distance selling. Member States implementing national redispensing frameworks are required to notify the European Commission of the types of medicines and categories of pharmacies covered, as well as any additional conditions they have applied.

Conclusion and next steps

The upcoming EU pharmaceutical law package opens the door for unused medical products to be redispensed to patients. As redispensing will be subject to strict conditions and article 207(a) of the revised Directive leaves its adoption to the discretion of Member States, the practical effect of this measure remains to be seen. For Member States that do choose to implement a redispensing framework, transposition into national law will be required. Please reach out to the authors of this article or the Hogan Lovells attorneys with whom you regularly work, to discuss what the new legislation could mean for your products.

Authored by Hein van den Bos and Milan Tuijp.