Preparations of tramadol, containing not more than 400 mg tramadol per measured dose in a mixture withone or more other ingredients or containing not more than 10 % tramadol if the preparations are not in doseform

Regulations amending the Swedish Medical Products Agency’s regulations (HSLF-FS 2021:75) onprescribing and dispensing medicinal products and industrial alcohol

Annex 11 to the Swedish Medical Products Agency’s regulations (HSLF-FS 2021:75) on prescribing anddispensing medicinal products and industrial alcohol lists which medicinal products constitute ‘specialmedicinal products’. Special medicinal products are subject to special regulation in certain cases in thespecified regulations. The draft regulations mean that tramadol is deleted from the second indent of Annex 11and that medicinal products containing tramadol in accordance with the Annex to the Swedish MedicalProducts Agency’s regulations (LVFS 2011:9) on the control of narcotic drugs are thus no longer specialmedicinal products within the meaning of that indent. Medicinal products containing tramadol will continue toconstitute special medicinal products in accordance with the first indent of Annex 11. The amendment is aconsequence of the amendment proposed in the Annex to LVFS 2011:9, whereby certain preparations oftramadol are no longer to be listed in the Annex.