Institute within the scope of the Federal Ministry of Health (BMG)
Institute within the scope of the Federal Ministry of Health (BMG)
(1) The authorities of the Federal Government and Laender responsible for the enforcement of this law shall work together with the Deutsches Institut für Medizinische Dokumentation und Information (German Institute for Medical Documentation and Information - DIMDI) to set up a joint central information system on drug products. This system puts together the information necessitated to fulfil the respective tasks, embracing all the authorities concerned. DIMDI sets up this information system on the basis of the data made available by the responsible authorities in line with the statutory instrument pursuant to subparagraph 3 and ensures its operational capacity. Data from the system shall be given to the competent federal higher authorities for their assignments regulated by the law. The transfer of data to other offices shall be permissible, as far as this is covered by the statutory instrument pursuant to subparagraph 3. DIMDI shall charge for its services subject to the statutory instrument pursuant to subparagraph 3.
(2) DIMDI may enable access to all generally available databanks that are related to drugs.
(3) The Federal Ministry shall be authorised to concede powers to process and use the data for the purposes defined in subparagraphs 1 and 2 and to collect data for the purposes of subparagraph 2 in agreement with the Federal Ministry for the Interior and the Federal Ministry of Economics by statutory instrument in consent with the Bundesrat and to draw up regulations for the transfer of data by authorities of the Federal Government and the Laender to DIMDI, including personal data for the purposes governed by this law, and in respect to the type, scope and requirements of said data. In this statutory instrument, it may also be stipulated that notifications on electronic or optic storage media may or must be effected, as and when this is necessary to ensure the correct enforcement of the regulations governing the market placement of drugs. Furthermore, charges may be set in this statutory instrument for services of DIMDI.
(4) The statutory instrument pursuant to subparagraph 3 shall be issued in agreement with the Federal Ministry for the environment, Nature Conservation and Nuclear Safety, if radioactive drugs are concerned or drugs, the production of which involves ionising radiation and, in Agreement with the Federal Ministry of Food, Agriculture and Forestry, if drugs intended for animal application are concerned.
(5)DIMDI takes the necessary measures to ensure that data are only transferred to duly authorised persons, solely said persons having access to said data.
Extract of the German Drug Law (AMG) (8th amending act, 7th September 1998)
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