The Medicines Law regulates all aspects of the pharmaceutical market. It ensures that medicines are safe, effective and of high quality, and it protects public health. To this end, it regulates, among other things, the manufacture, authorisation/registration, distribution and advertising, as well as clinical trials of medicinal products. Pharmaceutical law encompasses both national and EU law. Due to the ongoing harmonization, the latter plays a central role, especially since many medicinal products are marketed throughout the EU.
Pharmacy operations, the handling of narcotics, and activities involving substances of human origin (SoHO – blood components and cells/tissue for human use) are subject to special, additional regulations. In addition to national regulations and EU law, there are numerous international agreements and standards, such as those of the World Health Organization (WHO) or the International Conference on Harmonization of Technical Requirements for Medicinal Products for Human Use (ICH), that are of global importance.
Central areas of pharmaceutical law:
1. Admission and registration: Medicines may only be placed on the market after they have been authorized by the competent authority (in Germany, for example, the Federal Institute for Drugs and Medical Devices (BfArM) or at the EU level European Medicines Agency (EMA)) have received. The approval process includes evaluating the quality, safety, and efficacy of the medicinal product. For certain preparations (homeopathic medicinal products, traditional herbal medicinal products), registration is provided instead of approval.
2. Manufacture and Import: The pharmaceutical law regulates the requirements for the manufacturing and importation of medicinal products from countries outside the EU, including good manufacturing practice.Good Manufacturing Practice – Good Manufacturing Practice), which ensures that medicinal products and active pharmaceutical ingredients are manufactured under controlled conditions. Permission is generally required for the manufacture and import of medicinal products.
3. Sales: The distribution channel for medicinal products from the pharmaceutical manufacturer via the wholesaler or directly to pharmacies is also regulated. In principle, the dispensing of medicinal products to consumers, including doctors and hospitals, is reserved for pharmacies or hospital pharmacies. However, for certain preparations, direct distribution to hospitals/doctors is permitted exceptionally. In trade, the rules of Good Distribution Practice (Gross Domestic Product – Comply with Good Distribution Practice) and pharmacy law in pharmacy distribution. Furthermore, the provisions of the Medicines Pricing Ordinance must be observed. A license is also required for the wholesale trade of medicines.
4. Clinical TrialClinical trials with medicinal products serve to gain insights into their safety and efficacy. A clinical trial may only be commenced after it has been approved by the competent authority for the trial site, with significant consideration given to the opinion of the ethics committee. The principles of Good Clinical Practice (Google Cloud Platform – to observe Good Clinical Practice).
5. Pharmacovigilance: Medicines must also be continuously monitored by the marketing authorization holder during the marketing phase after authorization has been granted in order to ensure that they do not pose unacceptable health risks. The associated pharmacovigilance, documentation, and reporting obligations are subject to the requirements of the GVP Good Vigilance Practice
6. Advertising and information: The advertising of medicinal products is strictly regulated in the pharmaceutical advertising law. In particular, advertising may only take place if it is sufficiently scientifically proven and does not conflict with public health interests that limit the admissibility of advertising. Different requirements apply to advertising to laypeople and professionals (e.g. doctors).
7. Monitoring: Activities involving medicinal products, such as their production, trading or clinical testing, are subject to official monitoring. This ensures, including during inspections, that the actors comply with the law. The authorities are taking the necessary measures to this end.
8. Pricing and Reimbursement: In some countries, such as Germany, the pricing of medicines and their reimbursement are also regulated by statutory health insurance companies. SGB V contains detailed regulations on the pricing of medicines and their discounts.
9. Drug criminal law: Compliance with the strict regulation of medicines is sanctioned by a large number of criminal regulations and administrative offenses. This becomes important, for example, if medicines are manufactured, distributed or advertised in an unauthorized manner or if medicines are counterfeit.
Pharmaceutical law is closely linked to other legal areas such as medical law, data protection law, product liability law and competition law. Drug law not only protects public health, but also helps promote innovation in the pharmaceutical sector.
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