Federal Opium Agency
The Bundesopiumstelle (Federal Opium Agency) is one of 13 departments at the Federal Institute for Drugs and Medical Devices. It was set up in 1952 to succeed the Opium Department which in turn had been established following the International Opium Convention of 1912. Hence the obviously historically motivated name "Federal Opium Agency".Its four subdivisions, each headed by a pharmacist, are run by a staff of about 60 scientists and civil servants.
The trade in narcotics and psychotropics is regulated by the Narcotics Act of 1981 as well as in the subsequent orders (i.e.: Order concerning the Foreign Trade in Narcotic Drugs, Order concerning the Domestic Trade in Narcotic Drugs, Narcotic Drugs Prescription Order) and the trade in precursors by the Regulations (EC) No 273/2004, 111/2005 and the Delegated Regulation 2015/1011 as well as the Implementing Regulation and the Precursors Monitoring Act. Since 2009 the department is additionally responsible for the distribution of the special T-prescription forms for medicinal products containing the active substances lenalidomide, pomalidomide and thalidomide.
The agency's major tasks are the following:
- granting general licences to trade in narcotic drugs, psychotropic substances and precursors,
- supervising the trade in narcotic drugs, psychotropic substances and precursors among licence holders (manufacturers, traders, importers, exporters, cultivators and scientific institutions) by checking the reports submitted under Section 18 of the Narcotics Act and Article 9 of Delegated Regulation (EU) 2015/1011 and Article 10 of Implementing Regulation (EU) 2015/1013 and inspecting manufacturing sites, trading enterprises and storage facilities,
- issuing import and export authorisations for narcotic drugs and psychotropic substances
- granting import and export authorisations for precursors
- preparing and distributing special prescription forms for narcotic drugs
- maintaining a data base, also referred to as a substitution register
- distributing the special T-prescription forms for medicinal products containing the active substances lenalidomide, pomalidomide and thalidomide
- supplying statistical returns and regular reports to the International Narcotics Control Board (INCB) in Vienna concerning the use of narcotic drugs and psychotropic substances for medical and scientific purposes in Germany, and reports on the nature and extent of international trade where Germany is involved
- supplying reports to the European Commission on the nature and scope of cross- border trade in precursors
Those running a chemist's shop or a veterinary pharmaceutical store do not require a general licence as defined in the Narcotics Act. However, they must notify the Federal Opium Agency in writing beforehand that they are engaged in the trade with narcotics. Following notification, they receive confirmation together with a narcotics number allowing them to trade.Under the official notification of 9 th December 2002 (Federal Law Gazette I, page 26345) the Federal Opium Agency is named as the national contact agency for the implementation of the decision of the Council of the European Union concerning the transfer of samples of controlled substances.