Pharmaceutical law

from Wikipedia, the free encyclopedia

The pharmaceutical legislation regulates the manufacture, clinical testing and dispensing of medicines . The pharmaceutical law is supported by special pharmaceutical laws and other laws as well as various guidelines and regulations.

The main focus is on preventing danger, which is intended to ensure the health of the population. Pharmaceutical law is intended to guarantee that only safe and effective drugs are used and that drugs are not misused. That is why the manufacture and dispensing of drugs is subject to strict requirements. In the German-speaking countries, the drug laws regulate not only drugs for humans, but also veterinary drugs , including in particular drugs for farm animals.

Although the Edict of Salerno of 1231 is often mentioned as the origin of European pharmaceutical law , pharmaceutical law was largely only developed in the 20th century. The replacement of the pharmacy preparation of pharmaceuticals by industrial production as well as various pharmaceutical scandals were decisive influencing factors.

Pharmaceutical law is primarily assigned to administrative law . At the same time, it is a sub-area of ancillary criminal law and medical law . It can be distinguished from pharmaceutical law , as the latter also covers, for example, patent and social law aspects of pharmaceuticals as well as medical device law .

Basics of pharmaceutical law

The two main areas that drug law deals with are drug manufacturing and drug delivery. In addition, there is the clinical testing of drugs in clinical studies .

Drug manufacturing

The manufacture of pharmaceuticals is strictly regulated. Pharmaceutical companies require a manufacturing license for which a suitable production facility as well as expertise and reliability must be proven. Drugs must be manufactured in accordance with Good Manufacturing Practice . Similarly, when importing pharmaceuticals, an import permit is generally required. Pharmacies generally do not require a special manufacturing permit.

In some countries there is a special drug liability for pharmaceutical companies; in other countries, general product liability applies to medicinal products .

Drug delivery

A large number of legal regulations deal with the dispensing of medicines. In most countries, finished medicinal products are only allowed to be placed on the market if they have been approved by a competent pharmaceutical authority. The legal basis of drug approval is therefore a core area of ​​drug law. For finished medicinal products, there are detailed regulations for labeling, package inserts and other production information.

In addition, there are other special regulations for dispensing, such as the pharmacy requirement and the prescription requirement . In a broader sense, parts of pharmacy law and drug advertising can also be included in this area.

Clinical trial

The clinical trial examines the safety and effectiveness of a drug. The legal regulation of this area is a relatively new branch of pharmaceutical law. For many years there were only informal regulations and medical ethics , which were based on the Helsinki Declaration .

In the meantime, Good Clinical Practice to protect study participants is legally binding in many countries . This also gives the ethics committees a stronger position in the approval process for clinical studies.

Pharmaceutical law in selected legal systems

European Union pharmaceutical law

Large parts of pharmaceutical law have been harmonized in the European Union . The aim of this harmonization was to remove technical and scientific obstacles on the way to the European single market . The EU pharmaceutical law consists of EC directives and regulations . Directives are addressed to the member states who have to transpose them into national laws, while regulations are directly binding in all member states.

The first directive on the manufacture and marketing of medicinal products was directive 65/65 / EEC of 1965. This and the following directives were repealed in 2001 and replaced by directive 2001/83 / EC on the creation of a Community code for medicinal products for human use and directive 2001/82 / EC for the creation of a Community code for veterinary medicinal products. These new directives cover the entire area of ​​pharmaceutical production and the trade in pharmaceuticals, including the non-centralized Community procedures for drug approval.

Commission Directive 2003/94 / EC prescribes good manufacturing practice for the manufacture of pharmaceuticals . According to European pharmaceutical law, a qualified person must be responsible for the manufacture, testing and approval of the pharmaceuticals in every pharmaceutical company . Pharmaceutical companies must be based in a member state of the European Union .

Among the EC regulations, particular mention should be made of Regulation (EC) No. 726/2004 on the approval and monitoring of medicinal products and the establishment of the European Medicines Agency , which also defines the centralized Community procedure for the approval of medicinal products. The Regulation (EC) no. 470/2009 regulates maximum levels of antibiotic residues in foods of animal origin.

The clinical testing of medicinal products has only been regulated EU-wide since 2001 by Directive 2001/20 / EC on the application of good clinical practice (GCP Directive). In 2005, this was supplemented by Directive 2005/28 / EC on principles and guidelines of good clinical practice of the Commission, which regulates , among other things, details on investigational medicinal products.

With the EU pharmaceutical package of 2008, a number of new regulations were introduced that concern the improved monitoring of drug risks ( pharmacovigilance ) and the fight against counterfeit drugs . The planned relaxation of the existing ban on advertising for prescription drugs failed.

Main article: EU pharmaceutical package

All EU pharmaceutical law is accessible in the EudraLex database. There you will also find explanations under Notice to applicants and guidelines of the European Medicines Agency. These form what is known as soft law, which is not legally binding, but specifies the applicable state of science .

German pharmaceutical law

The core of the German drug law is the drug law of 1976 . This law regulates various aspects of drug manufacture, dispensing and clinical testing. The 1976 Act was preceded by the first Medicines Act of 1961, which implemented provisions from the Treaty of Rome of 1957. The 1961 law first introduced a manufacturing license and mandatory registration for medicinal products. In the trials following the thalidomide scandal , major deficiencies in the 1961 law became apparent; In a long-term legislative process, this led to the Medicines Act of 1976, which has been amended fifteen times to date. In the 1976 law, an authorization procedure was introduced to provide evidence of the quality, efficacy and safety of the drug. Furthermore, a special strict liability for drug damage was included in the law. Homeopathic remedies - if they do not indicate an area of ​​application - are excluded from the proof of effectiveness via a simplified registration procedure.

Other laws that can be assigned to pharmaceutical law in the broader sense are the Pharmacies Act of 1960 and the Narcotics Act of 1971, which replaced the Opium Act of 1929. The advertising of medicinal products is regulated in the Medicines Advertising Act of 1965 (revised 1994).

In addition to the laws, there are a number of ordinances and administrative provisions that are part of the pharmaceutical law. Many aspects of production are regulated in the Ordinance on the Manufacture of Drugs and Active Ingredients . Approval requirements are specified in the drug testing guidelines that transpose Annex I of Directive 2001/83 / EC into national law. For the dispensing of drugs, the drug prescription ordinance is to be used, for prescription narcotics the narcotics prescription ordinance . The Pharmacy Act is supplemented by the Pharmacy Operating Regulations ; details of the clinical trial are set out in the GCP regulation , which makes Good Clinical Practice binding.

According to Article 74 of the Basic Law, the law governing pharmacies, narcotics and medicines is subject to competing legislation . Texts of federal laws and regulations can be found on a website of the Federal Ministry of Health . In addition, there are various national regulations that are listed on a ZLG website .

In the German Democratic Republic there was a drug law (GDR) since 1964 .

Austrian pharmaceutical law

The core of Austrian pharmaceutical law is the Federal Act of March 2, 1983 on the Manufacture and Marketing of Medicinal Products ( Drugs Act (Austria) ). It is supplemented by the Pharmacies Act of 1906, the Prescription Requirement Act of 1972 and the Medicines Import Act of 2002.

The Medicines Act of 1983 replaced the Specialties Ordinance of 1947 and replaced the registration obligation for medicinal specialties with a drug approval procedure with proof of effectiveness.

The laws are supplemented, among other things, by the pharmaceutical company regulations for pharmaceutical production, the prescription requirement regulation and the delimitation regulation for pharmaceutical dispensing as well as the pharmacy operating regulations.

Texts of the laws and regulations can be found on the AGES-PharmMed website.

Swiss pharmaceutical law

In Switzerland , the Federal Act of December 15, 2000 on Drugs and Medical Devices ( Therapeutic Products Act ) regulates not only the authorization and dispensing of drugs, but also of medical devices . With the Therapeutic Products Act, previous cantonal, intercantonal and federal regulations were combined in one law. The federal competence for therapeutic products is regulated in Article 118 of the Federal Constitution .

The Therapeutic Products Act is supplemented by a number of Federal Council ordinances , including the Medicines Licensing Ordinance for the manufacture, wholesale, import and export of medicinal products; the Medicines Ordinance on the authorization of medicinal products, their division into dispensing categories and pharmacovigilance; the Ordinance on Advertising for Medicinal Products and finally the Ordinance on Clinical Trials with Medicinal Products, which stipulates that clinical studies with medicinal products must be carried out in accordance with the ICH Guideline on Good Clinical Practice.

In addition, Swissmedic's institute council ordinances exist, such as the drug approval ordinance.

The legal basis of Swiss pharmaceutical law can be found on a Swissmedic website.

Pharmaceutical Law in the USA

The first drug law in the United States was the Pure Food and Drug Act of 1906, which required clear labeling of drugs; an approval procedure has not yet been introduced. That happened three decades later with the Federal Food, Drug, and Cosmetic Act of 1938, which was passed in the wake of the sulfanilamide disaster . Central regulations of this law were tightened by the Kefauver-Harris Drug Amendment of 1962, which was discussed in parallel to the disclosure of the thalidomide scandal. With this amendment to the law, proof of the therapeutic effectiveness was required for the first time , which had to be proven in suitable, controlled studies (adequate and well-controlled studies) . Previously, it was sufficient to demonstrate the pharmaceutical manufacturing quality and the safety. Later, many pharmaceutical laws in other countries also required such proof of effectiveness. American drug law since 1962 has been in many ways a model that a large number of other countries have followed.

Current legal texts and regulatory guidelines can be found on a website of the Food and Drug Administration .

Individual evidence

  1. EudraLex European Medicines Law
  2. ^ Helga Blasius: 25 Years of the Medicines Act. The basis of our drug safety . In: Deutsche Apotheker-Zeitung . No. 41 , 2003. [1]
  3. German laws and ordinances on pharmaceuticals
  4. State legal regulations
  5. Legal foundations in Austria
  6. Legal basis for therapeutic products in Switzerland ( Memento from March 4, 2016 in the Internet Archive )
  7. Legal bases and regulatory guidelines in the USA


  • Erwin Deutsch , Andreas Spickhoff : Medical law: medical law, pharmaceutical law, medical device law and transfusion law. Berlin: Springer, 2003, ISBN 3-540-00048-8 .
  • Pharmaceutical law - comment: with official justifications, further materials and relevant legal provisions as well as a collection of court decisions , justified by Arno Kloesel, Walter Cyran , continued by Karl Feiden, Hermann Josef Pabel, Stuttgart: Deutscher Apotheker Verlag, 2008 (is continuously supplemented and updated), ISBN 978-3-7692-4656-8 .