To the attention of interested persons
Following the suspension by the EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES (EDQM) of Certificates of Suitability (CEP) to the Monographs of the European Pharmacopoeia for the active substance ranitidine hydrochloride, resulting from detection of nitrosamine impurities (NDMA), the National Agency for Medicines and Medical Devices of Romania (ANMDMR) has requested the barring from sale at pharmacy level of pharmaceutical forms for both oral administration and solution for injection of ranitidine containing medicinal products. This is a precautionary measure pending the European Commission decision on ranitidine containing medicines affected by this quality nonconformity.
In this respect, the NAMMDR has requested Marketing Authorisation Holders for these medicines to submit the following:
– an evidence of valid manufactured batches currently both held in their own warehouse and already distributed within the pharmaceutical network (warehouses and pharmacies), as well as of the batches manufactured and not yet released for sale;
– an inventory of distributors to whom the ranitidine containing batches have been distributed and the evidence of their notification on the barring from sale measure;
– an evidence of the quantities held in their own warehouse of the active substance ranitidine hydrochloride from manufacturers with suspended CEPs.
Under the circumstances, the NAMMDR advises healthcare professionals on the market availability of alternative treatments and recommends that patients see their doctor in this regard.