Changes to the conditions for dispensing tramadol
The French Medicines Agency has recently amended the conditions for dispensing tramadol, which is included in all medical supplies.
You will find below a joint SSGM/CCMM note on the new regulations and, in particular, on the need to prescribe on secure prescriptions.
You will find below a translation of this note:
From 1 March 2025, medicines containing tramadol, codeine or dihydrocodeine must be prescribed on a secure prescription.
These provisions apply to new prescriptions issued on or after 1 March 2025. Prescriptions issued before this date, including non-secure prescriptions, will remain valid until the end of the prescribed treatment period, but may not be renewed in the old format.By way of derogation, in order to ensure that patients have access to treatment and to finalise the roll-out to all prescribing healthcare professionals, we are asking that prescriptions drawn up between 1 March and 31 March 2025, which are not yet on secure prescription, still be honoured for the duration of the treatment prescribed, including any renewals. This derogation and transitional measure applies to both hospital and outpatient prescriptions.
These medicines are subject to the provisions of articles R. 5132-5 and R. 5132-29 of the French Public Health Code concerning narcotics.This applies to medical supplies A, B, B restricted, C, C restricted and P2. As with ampoules of morphine hydrochloride, Tramadol must be prescribed on secure prescriptions and the boxes of the drug kept under lock and key in a dedicated safe.
Similarly, prescriptions must be made by a doctor (art 217-3.05 and 217-3.07 of division 217), and a logbook for monitoring Tramadol will be created or added to that for morphine.