By extending the shelf life of dozens of common medicines, the ANSM hopes to avoid unnecessary disposal and better preserve available stock.
In brief
- The ANSM is partnering with 14 laboratories to reexamine the shelf life of 73 medicines.
- For 47 specialties, the proposed shelf life could reach four years or more.
- This extension must be validated for each drug, based on stability data.
- Patients must still follow the date printed on the package.
- Expired or unused medicines should be returned to the pharmacy.
Medicines: ANSM targets longer shelf lives
On August 26, 2026, the French Agency for the Safety of Medicines and Health Products announced the participation of 14 pharmaceutical laboratories in its “Long Life to Medicines” initiative. In total, 73 medicines are covered in this phase. The list includes especially specialties containing acetaminophen (paracetamol), levothyroxine, melatonin, lithium, and several antibiotics. The initiative does not mean patients can now ignore the printed dates on their boxes. It is a regulatory and scientific process: manufacturers must demonstrate, with stability data, that each affected medicine can retain its essential characteristics for the longer period, and then obtain a modification to its marketing authorization.
Today, most medicines authorized in France have a shelf life of two to three years, and fewer than 10% reach five years, notes the ANSM. This period is not a rough estimate: it is defined from stability studies conducted according to standardized references to ensure the product remains compliant throughout the stated duration.
However, the agency believes that some authorizations could be reevaluated when a lab has the necessary data. “For example, 47 of the 73 medicines could reach a shelf life of 4 years or more,” the ANSM notes. These are targeted durations to be considered, not a blanket change to the boxes currently in patients’ hands.
The official list provides a concrete sense of how substantial the potential extensions are.
- For DAFALGANTABS 1,000 mg
- EFFERALGAN 500 mg, both paracetamol-based, the indicated shelf life moves from 36 months currently to 60 months in the proposed scenario.
- Zolpidem marketed by Biogaran
- Almus would move from 48 to 60 months.
The gaps vary by molecule. Téralithe LP, a lithium-based product, is listed at 24 months today and 36 months in the proposed duration, according to the same ANSM list. Several dosages of Xurta, a lisdexamfetamine-based medicine, could move from 24 to 48 months. For the various presentations of Tcaps with levothyroxine, the duration would rise from 18 to 24 months. Actiskenan, a morphine-based product, targets 48 months instead of 36 today, while Baclocur could reach 60 months instead of 48.
Expiration date: what the ANSM does not change yet
The ANSM does not erase existing expiration dates with a stroke of a pen. The expiration date is tied to the authorization to market. To alter it, the manufacturer must provide elements showing that the product’s quality and properties are preserved during the additional period claimed. The competent authority can then consider a modification of the Marketing Authorization (MA). The French initiative is designed to support laboratories that commit to this process over the next five years.
This distinction prevents a very sensitive health misinterpretation. A theoretical duration that might be extended tomorrow does not guarantee that a medicine already expired today could be used. Storage conditions, packaging, product-specific stability data, and regulatory decisions continue to apply. The selected laboratories will be supported by the ANSM in their MA modification requests.
Medicines: the ANSM targets waste, shortages, and the carbon footprint
Behind this revision of dates lies, first and foremost, a matter of volume. More than 8,200 metric tons of medicines not consumed were collected in France in 2025 to be incinerated and valorized. Not all of these products were necessarily expired: the collections also include treatments that have become unused by their owners.
The PERIMED study provides further insight into this phenomenon. In 2024, 7,675 metric tons of unused medicines were returned to pharmacies. The study covered 32,840 units representing 1,125 different specialties. About four products out of ten analyzed were not yet expired at the time of return, and nearly 70% of the units studied were prescription-only.
Simply extending shelf lives will not, therefore, eliminate drug waste. The causes are multiple: packaging sometimes larger than needed, premature stopping of a treatment, adverse effects, poor adherence, or changes in health status. Nevertheless, PERIMED also highlights the role of short shelf lives for some everyday products, notably acetaminophen, ibuprofen, or anti-diarrheal medicines.
The issue is also financial. The cost of medicines that are ultimately not used is projected to be 517 million euros per year for Health Insurance. Of this amount, 278 million euros would correspond to medicines that were not yet expired at the time of consideration, notes the same outlet. La Tribune also cites the overall estimate of 517 million euros.
The lever is finally environmental. The French healthcare system accounts for more than 8% of national greenhouse gas emissions, nearly 50 million metric tons of CO2 equivalent. Medicines and medical devices represent 55% of this footprint, according to the agency. Avoiding the manufacture of a product that will ultimately be destroyed unused thus helps address multiple levels: raw materials, energy, packaging, transport, storage, and waste treatment.
Expiration date: how laboratories will need to evolve MAAs (Marketing Authorization)
The mechanism chosen by the ANSM is voluntary participation by industry. Fourteen laboratories answered the call, covering 73 medicines. The selection spans very different profiles, from medicines widely used in community settings to hospital products. The official document notably cites UPSA, Biogaran and Almus, AstraZeneca, Viatris Santé, IBSA Pharma, Ethypharm, Fresenius Kabi France, and Grünenthal.
The objective is not necessarily to extend every medicine to five years. Durations will be examined on a case-by-case basis. Some specialties would gain only six or twelve months, while others could see their shelf life double. Viatris’ diclofenac LP appears in the official document with a current duration of 36 months and a proposed 60 months. Inexium 40 mg injectable would go from 24 to 36 months and Versatis 700 mg from 36 to 48 months.
For pharmacies and health care facilities, the potential benefit lies in a less burdensome rotation of stock. A box that remains usable for longer is less likely to be pulled solely for expiration before it has been dispensed. The ANSM explicitly links this lever to better availability of treatments and to a reduced risk of shortages along the medication supply chain, while not presenting shelf-life extension as a universal fix to supply tensions.
The ANSM ties this lever to improved drug availability and to a reduced risk of medication shortages.
For patients, no new instruction directly follows this announcement. Until a new duration is validated and listed on the medication’s label, the indication on its packaging remains the one to follow. Expired or unused medicines must continue to be returned to the pharmacy rather than kept in anticipation of later regulatory changes.
Expired or unused medicines should still be returned to the pharmacy. Also find best practices for sorting expired or unused medicines.
