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The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced new regulations regarding the prescription and dispensing of tramadol, codeine, and dihydrocodeine, which will take effect on 1 March 2025. These changes aim to improve patient safety, reduce misuse, and ensure stricter control over these opioid-based pain medications.
Key Changes Taking Effect on 1 March 2025
Secure Prescriptions Required
Doctors must now prescribe tramadol, codeine, or dihydrocodeine on a secure prescription.
The dosage, dose, and duration of treatment must be fully written out in the prescription.
Pharmacists will only dispense these medications if the patient presents a secure prescription.
Shorter Prescription Validity for Codeine & Dihydrocodeine
Prescriptions for codeine and dihydrocodeine will now be valid for 12 weeks (3 months), matching tramadol’s existing rules.
A new prescription will be required for treatment beyond 12 weeks.
Transition Period: 1-31 March 2025
Prescriptions issued before 1 March 2025, including non-secure prescriptions, remain valid until the end of the prescribed treatment period but cannot be renewed under the old format.
Exception: To ensure continued patient access to treatment, ANSM has stated that prescriptions issued between 1 March and 31 March 2025, even if not on a secure prescription, will still be honoured for the full duration of the prescribed treatment, including renewals.
What This Means for Healthcare Professionals
Doctors must switch to secure prescriptions and specify the full dosage details.
Pharmacists can only dispense these medications upon presentation of a secure prescription.
Hospitals & Clinics: Must ensure compliance with the new prescription format to avoid disruptions in patient care.
What This Means for Patients
If you require tramadol, codeine, or dihydrocodeine, you must obtain a secure prescription from your doctor starting 1 March 2025.
If you have a prescription issued before this date, it remains valid until the end of the prescribed treatment period.
If your treatment extends beyond 12 weeks, you will need a new prescription from your doctor in a secure format.
Why These Changes Matter
The ANSM has implemented these regulatory updates to enhance patient safety, prevent misuse, and improve the monitoring of opioid-based pain medications. Healthcare providers and patients should prepare in advance to comply with the new requirements and avoid any disruptions in treatment.
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