BfArM - Federal Institute for Drugs and Medical Devices

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Licence and Registration

Any person who possesses, places on the market, imports, or exports precursors of Category 1 and/or engages in intermediary activities or drop shipping with them, requires a licence in accordance with Article 3 (2) of Council Regulation (EC) No. 273/2004 and/or Article 6 (1) of Council Regulation (EC) No. 111/2005 in order to do so. Exceptions to this rule are customs agents and carriers when acting solely in that capacity.
The Federal Institute for Drugs and Medical Devices issues licences for operators based in Germany.
Such a licence is applied for in an informal letter accompanied by the information and documents specified in Article 3 of Commission Delegated Regulation (EU) No. 2015/1011.

Please use the corresponding form sheet ("Erklärungsformblatt für den verantwortlichen Beauftragten") to notify the Federal Institute for Drugs and Medical Devices of the responsible officer appointed for the trade in scheduled substances ("Grundstoffverantwortlicher").

Pharmacies, the Bundeswehr (the German armed forces including administration and procurement authorities) as well as police and customs authorities were granted a special licence, published by announcement in the Federal Gazette ("Bundesanzeiger").

The handling of substances of Category 2 is subject to the registration obligation in accordance with Article 3 (6) of Council Regulation (EC) No. 273/2004 and/or with Article 7 (1) of Council Regulation (EC) No. 111/2005.
A registration for substances of Subcategory 2a is required for placing on the market and for possession, if the quantities of the substances exceed the threshod specified in Annex II of Reg. (EC) No 273/2004 over a period of one year.

For Subcategory 2b a registration is only required for placing on the market (if the quantities of the substances exceed the threshod specified in Annex II of Reg. (EC) No 273/2004 over a period of one year).
The handling of substances of Category 3 only requires a registration if these substances are exported to non-EU countries and if the annual export amount listed in Annex 1 of Commission Delegated Regulation (EU) No. 2015/1011 is exceeded.
Category 4 substances do not require a licence neither for trade within the EU nor for the import from or export to non-EU countries.
Both licence and registration are subject to fees; the taxation of costs to be charged is laid down in the Special BMG schedule of fees (Besondere Gebührenverordnung BMG).