Medicinal Products Act (Arzneimittelgesetz – AMG)
What is the subject of the German Medicine Act (AMG)?
The purpose of the German Medicine Act is to provide through the following regulations, the safety of the medicinal products, proving their quality, efficacy and harmlessness in order to obtain an appropriate pharmaceutical supply for people and animals.
This Act is also applicable to medicinal products; these are substances and preparations of substances that are meant to be used on human or animal bodies in case of diseases, sorrow, injuries or illness that need to be cured, alleviated or prevented.
The German Act on Medical Products (the AMG) is not applicable on medical devices. In this case the AMG comprehends numerous prohibitions and obligations. It is severely forbidden, to place “serious” drugs ( transl. “bedenkliche” Arzneimitteln) on the market (§ 5 AMG). With “serious” drugs, are intended all the medicinal products which, according to the state of the scientific knowledge, can have harmful effects on the human body.
Nonetheless, the German Medicine Act regulated traffic requirements of medical products (e.g. labeling obligations of active pharmaceutical products, package inserts, obligations to provisions of particular technical information), manufacture of medicines (e.g. requirements of manufacturing authorizations) and obviously, the related permissions, and the medical products dispensing (e.g. pharmacy obligations, self-serve prohibition, mail-order business, drug prescription, over the counter drugs).
What does the Medical Devices Act ( Gesetz über Medizinprodukte – MPG) regulate?
The purpose of the MPG is to regulate the transportation of medical devices, thereby ensuring the safety, suitability and efficiency of medical devices and the health and protection of patients, users and third parties.
Medical devices are all instruments, appliances, devices, substances and preparations of substances or other objects, including those used for the proper functioning of the medical device and the utilized software; those latter are used by the manufacturer for the application on people for the purpose of detection, prevention, monitoring, treatment or alleviation of diseases (§ 3 MPG).
The German MPG regulates e.g. infringements on the protection of patients, users and third-parties, the transportability of the products, responsibilities and also handle penal and bureaucratic regulations.
What is this German Act on Pharma Law all about?
Pharmacy Law (Apothekenrecht) is actually fluctuating between standardized European guidelines and national traditions. Central aspects of Pharmacy Law are regulated by the Pharmacy Act, the Pharmacy Operating Regulations as well as the legal regulation. In addition, there are numerous ordinances, e.g. the Pharmaceutical Price Regulation.
As far as concerned the Section 1 of the Pharmacy regulations (ApoG), pharmacies are obliged to ensure a proper supply of medicines for the public benefit of the citizens. Anyone who wants to open a pharmacy requires specific permissions of the competent authority. The authorization is valid only for the pharmacist who requested the permission, only for the premises designated in the license certificate.
The resulting particular cases (prohibition of mail-order business, branching, advertising bans, pricing principles, alternative products, etc.) can not be generalized; even insolvency law issues are arising nowadays.
Why is the Food Act or the Medicines Act a matter of particular importance?
In communications (advertising, packaging, etc.), foodstuffs, in particular dietary supplements, are often advertised as “marginal”; statements which are more likely to be attributed to a medicament, are particularly used in this cases. This could considerably affect the ability to transport and the applicability of the law on medicinal products.
According to § 2 (3) no. 1 of Medicine Law in connection with § 2 Code of covering food, articled of daily use and feeding stuff (LFGB), the issues regards the presence of foodstuffs in accordance with § 2 LFGB. According to this regulation, foodstuffs are products which are intended to be consumed by human beings, with the exception of those substances that are “predominantly” consumed for other purposes instead of nutritional or pure enjoyment´s purposes. The use of such foodstuffs is an essentially objective feature; food supplements as foodstuffs can only be obtained if the consumption is attributable to nutritional reasons, for example, an inadequate provision leads to the recourse of such food supplements. Thus, numerous labeling requirements as well as peculiarities in relation to the specific foodstuff, such as, for example, the dietary regulations, must be observed.
What do we need to work on your pharmaceutical legal issues?
As the respective problems in the individual legal areas are already really complex, it is opportune to discuss with us all the information and documents that are necessary to handle and solve your pharmaceutical legal questions.