Pharmaceutical Act, Medical Devices Act and Act on Pharmacies
What is the scope of the German Pharmaceutical Act (Arzneimittelgesetz, AMG)?
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 only, prohibition of self-service, prescription requirement, mail-order trade with medicines, etc.).
What is the scope of the Act on Medical Devices (Medizinproduktegesetz, MPG)?
The purpose of the Medical Devices Act is to regulate the trade in medical devices and, by doing so, to guarantee the safety, suitability and performance levels of medical devices as well to ensure adequate health protection of patients, users and other persons.
Medical devices are all instruments, apparatus, appliances, substances or preparations made from substances or other articles, used alone or in combination, including the software necessary for the medical device's proper application intended by the manufacturer to be used for human beings, by virtue of their functions, among others for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease (§ 3 of the Medical Devices Act).
The Medical Devices Act contains prohibitions the purpose of which is to ensure protection of patients, users and other persons, prerequisites for placing medical devices on the market and putting them into service, definition of responsibilities of competent authorities as well as fining provisions.
What does the Act on Pharmacies regulate?
The pharmaceutical law comprises in the first place the Act on Pharmacies (Apothekengesetz), the Rules Governing the Operation of Pharmacies (Apothekenbetriebsordnung), the professional code and other regulations, such as the Regulation on the Prices of Medicines (Arzneimittel-Preisverordnung). The German pharmaceutical law is presently undergoing transition from a national tradition towards European harmonisation.
Pursuant to Section 1 of the Act on Pharmacies, pharmacies are obliged to ensure the orderly supply of medicines to the entire population of Germany. Anyone who wants to pursue the profession of pharmacist in Germany needs certification as a pharmacist. Any qualified pharmacist must be ad personam authorised to run a pharmacy.
Mail-order trade with medicines, price maintenance rules, price advertising prohibitions are examples of other issues that are dealt with in the Act on Pharmacies.
What role does the Pharmaceutical Act 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 of § 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, Medical Devices Act or Act on Pharmacies?
Due to the complex nature of the abovementioned areas 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.