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Legal Basis and Supervision

The trading of narcotic substances (narcotics and psychotropics) and precursors is regulated in the Betäubungsmittelgesetz – Narcotics Act – of 1981 (BtMG) and the regulations passed regarding this (BtM-Außenhandelsverordnung – Foreign Trade Regulation -, BtM-innenhandelsverordnung – Domestic Trade Regulation -, BtM-Verschreibungsverordnung – Prescription Regulation) as well as in regulations (EC) nos.273/2004, 111/2005 and the Delegated Regulation (EU) 2015/1011 as well as the Implementing Regulation (EU) 2015/1013 and the supplementary Commodities Control Act.

These regulations form the basis for the tasks of the Federal Opium Agency of the BfArM, which was established in 1952 from the opium department set up in response to the International Opium Convention of 1912. The designation of the Federal Opium Agency (BOPST) should therefore be viewed from a historical perspective. In the recent past (08 February 2009) the department undertook the issuing of special prescriptions for lenalidomide, pomalidomide and thalidomide. The approximately 50 staff (researchers, upper and mid-level civil servants, administrative clerks) are distributed across four specialist areas, each of which are headed by a pharmacist.

The implementing authority as per § 3 et seq, § 19 BtMG is the Federal Institute for Drugs and Medical Devices.

www.Federal Institute for Drugs and Medical Devices

Fachgebiet 83
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

The wholesale trading in pharmaceuticals is regulated by the Arzneimittelgesetz (AMG) – Medicines Act – (see § 52a AMG).

The supervisory authority is the State Office for Health and Social Affairs (LAGeSo)

Postal address: P.O. Box 310929, 10639 Berlin
Office building: Turmstr 21, 10559 Berlin
Phone: +49 30 90229-0


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