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id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jaqbel fuq id- dettalji tal- kard ta ’ twissija tal- pazjent (pac) ma ’ l- awtoritajiet kompetenti nazzjonali u għandu jipprovdi dan il- pac direttament lill- ispiżerija ma ’ kull kunsinna ta ’ ranexa.
the mah must agree the details of a patient alert card (pac) with the national competent authorities and must provide this pac directly to the pharmacy with each ranexa shipment.