Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
Section 12
Empowerment in respect of labelling, package leaflet and package sizes
(1) The Federal Ministry is hereby empowered, in agreement with the Federal Ministry for Economic Affairs and Energy by ordinance subject to the approval of the Bundesrat:
1. to extend the provisions of Sections 10 and 11a to cover other medicinal products and to extend the expert information to include further details,
2. to stipulate that the information indicated in Sections 10 and 11 are to be made known to the consumer in another way,
3. to stipulate that, for certain medicinal products or certain groups of medicinal products, warnings, warning symbols or recognition marks shall be contained in or affixed to:
a) the containers, the outer packaging or the package leaflet or
b) expert information
4. to stipulate that specific constituents are to be listed by nature on the containers and outer packaging or that attention should be drawn to them in the package leaflet,
if this is deemed necessary in order to ensure the proper handling and proper administration of medicinal products within the purview of this Act and in order to prevent any direct or indirect risk to human or animal health, which could occur as a result of inadequate information.
(1a) Furthermore, the Federal Ministry is hereby empowered to allow, by ordinance subject to the approval of the Bundesrat, the use of summarizing names for substances or preparations from substances in the information provided on containers and outer packaging or in package leaflets or in expert information, as long as active constituents are not involved and no direct or indirect hazard to human or animal health arising from inadequate of information is to be feared.
(1b) Furthermore, the Federal Ministry is hereby empowered, in agreement with the Federal Ministry for Economic Affairs and Energy, by means of an ordinance subject to the approval of the Bundesrat to regulate:
1. the labelling of starting materials intended for the manufacture of medicinal products, and
2. the labelling of medicinal products intended for clinical trials,
where it is deemed necessary to prevent a direct or indirect hazard to human or animal health owing to inadequate labelling.
(2) In the case of medicinal products intended for administration to animals, the Federal Ministry of Food and Agriculture shall take the place of the Federal Ministry in the cases provided for in sub-section 1, 1a, 1b or 3, and shall in each case issue the ordinance in agreement with the Federal Ministry. The ordinance pursuant to sub-section 1, 1a or 1b shall be issued in agreement with the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety in the case of radiopharmaceuticals and medicinal products in the manufacture of which ionizing radiation is used or where, in the cases provided for in sub-section 1 number 3, warnings, warning symbols or recognition marks with regard to the information stipulated in Section 10 sub-section 1 sentence 1 number 13 or sub-section 5 sentence 1 number 10, Section 11 sub-section 4 sentence 1 number 9 or Section 11a, sub-section 1 sentence 2 number 6 letter f are required.
(3) Furthermore, the Federal Ministry is hereby empowered to stipulate, by ordinance not subject to the approval of the Bundesrat, that medicinal products may only be placed on the market in specific package sizes and that they shall be labelled accordingly by the pharmaceutical entrepreneur on the container or, if used, on the outer packaging. The fixing of these package sizes shall be done for specific active substances and shall take into account the therapeutic indications, the duration of application and the pharmaceutical form. In fixing the package size, the following sub-division shall, in principle, be used as a basis:
1. packages for a short duration of application or tolerance tests,
2. packages for an intermediate duration of application,
3. packages for a relatively prolonged duration of application.
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