Medicines law

Key areas of pharmaceutical law:

• Authorization and registration: Medicinal products may only be placed on the market after receiving authorization from the competent authority (in Germany, for example, the Federal Institute for Drugs and Medical Devices (BfArM) or, at the EU level, the European Medicines Agency (EMA)). The authorization procedure includes testing the quality, safety, and efficacy of the medicinal product. For certain preparations (homeopathic medicinal products, traditional
  herbal medicinal products), registration is required instead of authorization.
• Manufacturing and import: Pharmaceutical law regulates the requirements for the manufacture and import of medicinal products from countries outside the EU, including Good Manufacturing Practice (GMP), which ensures that medicinal products and active ingredients are manufactured under controlled conditions. A permit is generally required for the manufacture and import of medicinal products.
• Distribution: The distribution of pharmaceuticals from pharmaceutical companies via wholesalers or directly to pharmacies is also regulated. In principle, the dispensing of pharmaceuticals to consumers, including physicians and hospitals, is reserved for pharmacies or hospital pharmacies. However, for certain preparations, direct sales to hospitals/doctors are permitted in exceptional cases. The rules of Good Distribution Practice (GDP) must be observed at the retail level, and pharmacy law must be observed in pharmacy sales. Furthermore, the requirements of the Pharmaceutical Price Ordinance must be observed. A license is also required for the wholesale distribution of pharmaceuticals.
• Clinical trial: Clinical trials of medicinal products are intended to gain insights into their safety and efficacy. A clinical trial may only begin after it has been approved by the authority responsible for the trial site, taking significant account of the opinion of the ethics committee. The principles of good clinical practice (GCP) must be observed during planning and conduct.
• Pharmacovigilance: Medicinal products must be continuously monitored by the marketing authorization holder, even during the marketing phase after approval has been granted, to ensure that they do not pose unacceptable health risks. The monitoring, documentation, and reporting obligations applicable in this regard are subject to the requirements of GVP (Good Vigilance Practice).
• Advertising and information: Advertising for medicinal products is strictly regulated by the law on advertising medicinal products. In particular, advertising may only be carried out if it is sufficiently scientifically sound and does not conflict with public health interests that would otherwise restrict the admissibility of advertising. Different requirements apply to advertising directed at laypeople and members of the medical profession (e.g., physicians).
• Monitoring: Activities involving medicinal products, such as their manufacturing, distribution, or clinical trials, are subject to regulatory monitoring. This ensures, including through inspections, that operators comply with legal regulations. The authorities take the necessary measures to this end.
• Pricing and reimbursement: In some countries, such as Germany, the pricing of pharmaceuticals and their reimbursement are also regulated by statutory health insurance funds. The German Social Code (SGB V) contains detailed regulations on pharmaceutical pricing and discounting.
• Pharmaceutical criminal law: Compliance with the strict pharmaceutical regulations is punished by a variety of criminal provisions and administrative offenses. This becomes relevant, for example, when pharmaceuticals are manufactured, distributed, or advertised illegally, or when they are counterfeit.

Pharmaceutical law is closely intertwined with other areas of law, such as medical law , data protection law , product liability law , and competition law. Pharmaceutical law not only protects public health but also contributes to promoting innovation in the pharmaceutical sector.