Anwalt Deutschland Fachanwalt deutsch German Lawyer Germany English language Attorney-at-law English Lawyer germany french advocat francais allemagne French Attorney in Germany spanish language abogado alemania Spanish Attorney/ Lawyer in Germany Italian language avvocatto germania Italian Lawyer/ Attorney Germany Portuguese language advogado Alemanha Portuguese Polish speaking Lawyer/ Attorney in Germany adwokat Niemcy Polish Japanese speaking Lawyer/ Attorney in Germany Bengoshi Doitsu Japanese Attorney/ Lawyer Vietnamese language luat su Vietnamese Korean speaking lawyer/ attorney in Germany, Europe Korean Chinese language Lawyer/ Attorney in Germany/ Europe Chinese Lawyer/ Attorney russian speaking advokat Germaniya Russian



Law Office   Lawyers/ Patent Attorneys   Main practice areas   Legal matters   Client Service   Litigation   Free templates   Offices   Brochures   Contact   News   Press   FAQ  

Attorneys at law



Competition law  Copyright law  Trademark law  Design law  Patent law  Media law  Online law  Food law  Public law  ITC

German Lawyer patent attorney Germany trademark attorney design attorney european law german attorney hannover germany based attorney at law for ip law it law competition law european law and regulations in germany litigation file suits representative  file german trademark law tm  competition copyright design food law media law patents contract law online law internet law patent law design protection file german patent utility model law lawyer it law contract law agricultural law architectural law banking law civil cervis law domain law employee inventions law financial penalties law food law guarantee law labour law land law pharma law state aid law waste law

Start   IP Application Services   Contact   Online enquiry   Imprint   Data Protection 



...Start ...Main practice areas ...Pharma law
Main practice areas 
Administrative law 
Agricultural law 
Animal law 
Anti Trust law 
Architectural law 
Banking law 
Brokerage law 
Business law 
Capital Market law 
Civil law 
Civil service law 
Commercial law 
Commercial Criminal law 
Competition law 
Construction law 
Contract law 
Copyright law 
Corporate law 
Cosmetic law 
Customs law 
Data protection law 
Design law 
Distribution law 
Domain law 
Domain Arbitration law 
Education law 
Employee invention law 
Energy law 
Engineering law 
Environment law 
European law 
Event law 
Family law 
Film law 
Financial penalties law 
Fiscal Offences law 
Food law 
Gambling law 
Guarantee law 
Higher Education law 
Image rights 
Industrial law 
Inheritance law 
Insolvency law 
Insurance law 
International law 
International Trade law 
Internet law 
IP law 
IT law 
Labour law 
Land law 
Law on associations 
M&A law 
Mail order law 
Media law 
Medical malpractice law 
Medical Products law 
Medicine law 
MLM law 
Music law 
Online law 
Patent law 
Pharma law 
Plant variety law 
Photography law 
Press law 
Publishing law 
Public commercial law 
Public procurement law 
Purchasing law 
Real Estate law 
Restaurant law 
Sales representaves rights 
Sports law 
State Aid law 
Students rights 
Tax law 
Technology law 
Tenancy law 
Telecommunications law 
Terms and conditions law 
Tort law 
Trademark law 
Traffic law 
Transport law/Shipping law 
Waste law 
Wine law 
Lawyers/ Patent Attorneys 
Main practice areas 


Lawyers Hannover
Attorneys at law
Patent AttorneYs
Trademark Attorneys
Design Attorneys


Georgstr. 48
30159 Hannover

Tel +49.511/357356-0
Fax +49.511/357356-29


Lawyers Munich

Landshuter Allee 8-10
80637 Munich

Tel.: +49.89.2500790-50
Fax: +49.89.2500790-59


Lawyers Vienna

Trauttmansdorffgasse 8
1130 Vienna

Tel.: +43.1.8761517
Fax: +49.511.357356-29



Pharmaceutical products, medical device and pharmacy  Law  (German AMG) - horak Attorneys at Law, Germany

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 Law is applicable to medicines. Medicinal products 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 cure, alleviate prevent or in some cases recognized.

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 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 when used.

Thus, the German Medicine Act regulated traffic requirements of medical products (f.i. labeling obligations of active pharmaceutical products, package inserts, obligations to provisions of particular technical information), manufacture of medicines (f.i. requirements of manufacturing authorizations) and obviously, the related permissions, and the medical products dispensing (f.i. pharmacy obligations, self-serve prohibition, mail-order business, drug prescription, over the counter drugs).

Das MPG regelt Verbote zum Schutz von Patienten, Anwendern und Dritten, die Verkehrsfähigkeit von Medizinprodukten, accountabund enthält auch Straf- und Bussgeldvorschriften.

What does the Medical Devices Act (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, apparatus, 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 MPG regulates Bans for the protection of patients, users and third-parties, the transportability of the products, responsibilities and also handle penal and bureaucratic regulations.

What does pharmacy law mean?

Pharmacies law 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 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.

Other topics:

  • Pharmacy
  • Intellectual Property
  • Pharma law
  • Drug permission
  • Pharmaceutical Testing
  • Pharmaceutical distribution
  • Medical Law
  • Unfair competition law
  • Health claims

horak law office germany hannover lawyer representative compliance design infringement warning letter business start up law guarantee warranty liability border seizure leasing trademark infringement mediation minimum wage patent attorney patent infringement pro bono legal advice piracy product piracy brand piracy counterfeit litigation arbitration disputes renovation compensation online sales youtube pinterest instagram copyright infringement deutsch german law german court lawyer litigator german litigator hannover english

© German lawyer Michael Horak 2002-2018

 trademarks patents designs law lawyer german law firm litigator litigation file court suit attorney Germany patent attorney agricultural law architectural law contract law employee inventions law medical malpractice law pharma law terms and conditions law gtc waste law print  attorney at law hannover germany europe trademark competition law save attorney solicitor hannover stuttgart berlin munich german law firmback  german law european law european lawyer specialist expert german law competition law germany copyright law german design lawyer food attorney media law germany online and computer lawyers patent law patent application telecommunications law office trademark law firm classical and modern physics solid state physics mechanics Laser Physics Electrical electronic radiofrequency technologies Telecommunications telematics Mechatronics Information Technology Data Processing Technology image processing technology semiconductor technology consumer electronics computer hardware IT technology software telecommunications automation optics Atomic Physics Molecular Physics Engineering Construction Automotion shipbuilding aircraft Drive Technology Control Technology Process Engineering Production Engineering Production Technology Packaging Paper Technique Product Development Measurement Control Engineering Process Technology Appliances Small Appliances Food Technology Aerospace safety technology power plant technology material technology steelmaking alloys nanotechnology plastics energy technology renewable energy Life Sciences Medical Biology Biophysics biotechnology Microbiology Cell Biology Neurobiology Molecular Biology gene therapy bioinformatics Pharmacy Pharmacology agents Biochemistry Chemistry Physical Chemistry Organic Chemistry Inorganic Chemistry Pharma antibody technology biosimilar generic diagnostic plant biotechnology diagnostic technology implants Immunology enzyme replacement therapy proteins muteins enzymes Transgenic cytokines, ribozymes, antisense RNA, RNAi Virology GM microorganisms plants animals human medicine food polymers catalysts lithography PhotographyOnline-Request