Last Updated on May 29, 2021 by LawEuro
Medicinal Products Act (Laws / Regulations of Germany)
CHAPTER TWO
Requirements on medicinal products
Section 5
Prohibition of unsafe medicinal products
(1) The placing on the market or the use of unsafe medicinal products on another human being is prohibited.
(2) Medicinal products shall be considered unsafe if, according to the current level of scientific knowledge, there is sufficient reason to suspect that, when used in accordance with their intended purpose, they have harmful effects that exceed the limits considered tolerable in the light of current medical knowledge.
Section 6
Empowerment in respect of health protection
(1) The Federal Ministry of Health (the Federal Ministry) is hereby empowered to specify, restrict or prohibit, by ordinance subject to the approval of the Bundesrat, the use of certain substances, preparations from substances or objects in the manufacture of medicinal products and to forbid the marketing and use of medicinal products that have not been manufactured in compliance with these regulations in so far as this is deemed necessary in the interest of risk prevention or in order to prevent medicinal products from posing a direct or indirect hazard to human or animal health. The ordinance pursuant to sentence 1 shall be issued by the Federal Ministry of Food and Agriculture in agreement with the Federal Ministry in so far as the medicinal products are intended for administration to animals.
(2) The ordinance referred to in sub-section 1 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.
Section 6a
(repealed)
Section 7
Radiopharmaceuticals and medicinal products treated with ionizing radiation
(1) The placing on the market of radiopharmaceuticals or medicinal products in the manufacture of which ionizing radiation has been used shall be forbidden, unless the authorisation to do so has been granted by ordinance according to sub-section 2.
(2) The Federal Ministry is hereby empowered to authorize, in agreement with the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety, by means of an ordinance subject to the approval of the Bundesrat, the placing of radiopharmaceuticals on the market or the use of ionizing radiation in the manufacture of medicinal products in so far as this is deemed, according to the current level of scientific knowledge, to be justified for medical purposes and in so far as it does not compromise human or animal health. The ordinance may prescribe the channel of distribution for the medicinal products and specify that certain data concerning their radioactivity are to appear on the container, the outer packaging and the package leaflet. The ordinance shall be issued by the Federal Ministry of Food and Agriculture in agreement with the Federal Ministry and the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety, in so far as medicinal products intended for administration to animals are concerned.
Section 8
Prohibitions to prevent deception
(1) It shall be prohibited for medicinal products or active substances:
1. that, by deviating from recognized pharmaceutical rules, are of considerably reduced quality, or
1a. (repealed)
2. that bear misleading names, specifications or presentations to be manufactured or placed on the market. Deception shall be deemed to exist, in particular, in cases where:
a) claims are made to the effect that certain medicinal products have a therapeutic efficacy or effects which they do not possess or that active substances exhibit an activity which they do not,
b) the erroneous impression is given that success can be expected with certainty or that no harmful effects can be expected to occur when the medicinal product is used in accordance with its intended purpose or over a prolonged period,
c) names, specifications or presentations having an influence on the assessment of the medicinal product or active substance are employed to mislead others with regard to its quality.
(2) It shall be prohibited for falsified medicinal products or falsified active substances to be placed on the market, or otherwise traded.
(3) It shall be prohibited for a medicinal product to be placed on the market after its expiry date has elapsed.
Section 9
The party responsible for placing on the market
(1) Medicinal products that are placed on the market within the purview of this Act shall bear the name or the company and the address of the pharmaceutical entrepreneur. This shall not apply to medicinal products intended for use in a clinical trial on human subjects.
(2) Within the purview of this Act, medicinal products may only be placed on the market by a pharmaceutical entrepreneur whose registered place of business is situated within the purview of this Act, in another Member State of the European Union or another State Party to the Agreement on the European Economic Area. If the pharmaceutical entrepreneur appoints a local representative, this shall not release him/her from his/her legal responsibility.
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