- Tramadol preparations

- Cocaine preparations

Regulations amending the Swedish Medical Products Agency's Regulations (LVFS 2011:9) on the Control of Narcotic Drugs

Section 2 and the Appendix to the Swedish Medical Products Agency's regulations (LVFS 2011:9) on theControl of Narcotic Drugs regulate which narcotic substances are exempted from certain provisions in theregulations on the control of narcotic drugs. The exemptions concern, inter alia, authorisation requirements incertain situations and rules concerning the handling of narcotic drugs. Certain Tramadol preparations arecurrently exempted from these provisions. The draft regulation means that these preparations will no longer beexempt, which results in tighter regulation for these Tramadol preparations. Furthermore, the draft means thatcertain cocaine preparations will be included in the exemptions.

The draft concerns the following goods:
- Tramadol preparations containing not more than 400 mg Tramadol per divided dose in a mixture with one ormore other ingredients or containing not more than 10 percent Tramadol, if the preparations are not dividedinto doses
- Cocaine preparations containing in a mixture not more than 0.1 percent cocaine, calculated as cocaine base,mixed with one or more non-narcotic substances in such a way that the constituent narcotic drug cannot beextracted by simple methods.