BfArM - Federal Institute for Drugs and Medical Devices

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Narcotic drugs

Narcotic drugs

Narcotic drugs ("Betäubungsmittel", BtM) as defined by the German Narcotic Drugs Act ("Betäubungsmittelgesetz", BtMG) are the substances and preparations listed in Schedules I to III of that Act. A substance or preparation is included in these Schedules if this is scientifically justified based on its mode of action. Also a substance's potential to cause dependence, the possibility of producing narcotics from it, or the extent of abuse as well as its direct or indirect danger to health can lead to its inclusion in the Schedules. Such substances and preparations are also subject to the BtMG if required based on amendments to the Schedules to the Single Convention on Narcotic Drugs of 1961 or the Convention of 1971 on Psychotropic Substances.

In Germany, control of the legal trade in narcotic drugs belongs to the tasks of the Federal Opium Agency at the BfArM. However, there are the following exceptions to this rule that are within the responsibility of the respective competent health authorities of the "Laender": the traffic in narcotics involving physicians, dentists, and veterinarians as well as in pharmacies, veterinary dispensaries, hospitals, and animal hospitals.

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.

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Notifications

In accordance with Section 18 of the German Narcotic Drugs Act ("Betäubungsmittelgesetz", BtMG), all participants in the trade with narcotic drugs who have been issued a licence in accordance with Section 3 BtMG, are obligated to submit regular notifications on all movements and manufacturing processes in that connection. These notifications shall be submitted to the BfArM for the preceding calendar half-year by 31 January and 31 July. This does not apply to notifications in connection with the cultivation of narcotic drugs; such notifications only have to be submitted once by 31 January for the preceding calendar year.

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Records

The holder of a licence pursuant to Section 3 of the German Narcotic Drugs Act ("Betäubungsmittelgesetz", BtMG) is obligated to document every quantity received or supplied and the resulting stock consecutively and separately for each narcotic drug and each site. For details on the information to be given for every increase and decrease in stock please refer to Section 17 BtMG.

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Import and Export

In accordance with Section 11 sub-section 1 of the German Narcotic Drugs Act ("Betäubungsmittelgesetz", BtMG), an authorisation from the BfArM is necessary for each import and export of narcotic drugs.

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Travelling with narcotic drugs

Patients can export or import narcotics that they have been prescribed by a doctor in the amount required for the duration of a trip.

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Information on groups of substances

The following groups are wholly or partly subject to the legal provisions on narcotics and psychotropic substances

  • the esters, ethers, molecular compounds and salts of the substances listed in the schedules of the Narcotics Act, with the exception of the esters and ethers of gamma hydrobutyric acid
  • the stereoisomers of the substances listed in the schedules of the Narcotics Act if drugabuse is intended
  • organisms and parts of organisims in a processed or unprocessed form with substances listed in the schedules of the Narcotics Act, as well as biologic materials, which are suitable for reproduction or extracting organisms mentioned above, if drugabuse is intended
  • the preparations of the substances listed in the schedules of the Narcotics Act if they
  1. are not to be used exclusively for diagnostic or analytical purposes without being used in human and animal bodies and their content of one or more narcotics does not exceed 0.001 (for substances under Schedule I) or 0.01 (for substance under Schedules II or III), or the substances have been isotopically modified or
  2. have not been specifically exempted. For exempted preparations under Schedule III - except for those containing codeine or dihydrocodeine -, however, the legal provisions on import, export and transit through Germany apply. Exempted preparations under sub-paragraph (b) of the position barbital (cf. list of substances listed in the schedules of the Narcotics Act), however, may be imported, exported or transited through Germany without authorization under Section 11 of the Narcotics Act if there is no cause for concern that they will be misused.