BfArM - Federal Institute for Drugs and Medical Devices

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Licences

Section 3 of the German Narcotic Drugs Act ("Betäubungsmittelgesetz", BtMG) specifies that a licence is necessary for engaging in the traffic with narcotic drugs. This licence is granted by the BfArM's Federal Opium Agency upon request. It is issued for the relevant company, institution etc., for the respective site, and for the required scope of the traffic in narcotic drugs. Such licences are granted with time limits for equally temporary undertakings. The BfArM's homepage provides forms and explanations regarding requests for such licences from different types of applicants. Licences are subject to fees; the taxation of costs to be charged is laid down in the Ordinance on Charges for Narcotics ("Betäubungsmittel-Kostenverordnung", BtMKostV). New licences are to be applied for if there are changes as to the holder of the licence or the location of the site.

The holder of a licence accepts certain obligations along with the issuance of the licence. These include the obligations to keep records in accordance with Section 17 BtMG and to submit notifications in accordance with Section 18 BtMG on a half-yearly basis (or yearly for cultivators).

If the licence is waived, this can be indicated informally by attaching the original licence document and a final notification covering the last reporting period.
Exemptions from this obligation to obtain a licence are listed in Section 4 BtMG.