Pharmaceutical law

What is the scope of the German Pharmaceutical Act?

The purpose of the Pharmaceutical Act is to guarantee, in the interest of furnishing both human beings and animals with a proper supply of medicines, safety in respect of the trade in medicines, ensuring in particular the quality, efficacy and safety of medicines in accordance with the provisions of this Act.

The Pharmaceutical Act applies to medicines. Medicines are substances and preparations made from substances which, by application on or in the human or animal body are intended among others to cure, alleviate, prevent or diagnose diseases, suffering, bodily injury or disease symptoms.

The Pharmaceutical Act does not apply to medical devices.

The Pharmaceutical Act contains numerous prohibitions and duties. It is for instance prohibited to place „unsafe“ medicines on the market (§ 5 of the Pharmaceutical Act). Medicines are considered „unsafe“ if, according to the current level of scientific knowledge, there is reason to suspect that, when used in accordance with their intended purpose, they have harmful effects which exceed the limits considered tolerable in the light of current medical knowledge.

The Pharmaceutical Act also regulates requirements for medicines which are placed on the market (e.g. labelling of finished medicines (§ 10 of the Pharmaceutical Act), package leaflets, expert information), as well as the manufacturing of medicines (manufacturing authorisation is necessary) their registration and supply (keywords: obligation to dispense medicines in pharmacies, prohibition of self-service, prescription requirement, mail-order trade with medicines, etc.).

What role does the Food and Commodity Goods Law or the Law on Advertising in the Healthcare System play?

As far as communication (advertising, package, etc.) is concerned, articles of food, especially dietary supplements are often advertised „in a boundary area“, namely by means of statements which could rather be attributed to medicines. The latter would, however, significantly reduce the marketability of such products, and could moreover lead to the application of the Law on Advertising in the Healthcare System.

According to § 2 (3) Nr. 1 of the Pharmaceutical Act and § 1 of the Food and Commodity Goods Law, the question has to be answered first if we are concerned here with an article of food as defined by § 1 of the Food and Commodity Goods Law. This law defines articles of food as substances which are intended to be consumed by human beings, which excludes substances which are consumed „predominantly“ for purposes other than nourishment or pleasure. Considering the purpose of a substance and its actual role on the market, the possible ways it can be used are decisive as objective characteristics. Thus, dietary supplements can be regarded to be articles of food, only if their consumption can be put down to nutrition grounds, i.e. if insufficient nutrition leads to consuming such dietary supplements.

What do we need to handle your legal question relating to the Pharmaceutical Act?

Due to the complex nature of the abovementioned area of law, we cannot state in general what information and documents we need in order to handle your legal question. Please contact us for details.