Medicinal Products Act (Laws / Regulations of Germany) CHAPTER SEVENTEEN Penal provisions and provisions on administrative fines Section 95 Penal provisions (1) A period of imprisonment not exceeding three years or a fine shall be imposed on any person who:…
Liability for damages caused by medicinal products
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER SIXTEEN Liability for damages caused by medicinal products Section 84 Absolute liability (1) If, as a result of the administration of a medicinal product intended for human use, which was distributed…
Designation of the competent higher federal authorities and other provisions. Medicinal Products Act
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER FIFTEEN Designation of the competent higher federal authorities and other provisions Section 77 Competent higher federal authority (1) The competent higher federal authority shall be the Federal Institute for Drugs and…
Information officer, pharmaceutical consultant
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER FOURTEEN Information officer, pharmaceutical consultant Section 74a Information Officer (1) Any person who, as a pharmaceutical entrepreneur, places medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2…
Import authorisation. Medicinal Products Act
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER THIRTEEN Import and export Section 72 Import authorisation (1) Any person who wishes to import: 1. medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1,…
Special provisions for the Federal Armed Forces, Federal Police, Public Order Police, Civil Protection. Medicinal Products Act
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER TWELVE Special provisions for the Federal Armed Forces, Federal Police, Public Order Police, Civil Protection Section 70 Application and enforcement of the Act (1) The provisions of this Act shall apply…
Surveillance. Medicinal Products Act
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER ELEVEN Surveillance Section 64 Conducting supervision (1) Enterprises and establishments in which medicinal products are manufactured, tested, stored, packaged or placed on the market, in which they are otherwise traded, or…
Pharmacovigilance. Medicinal Products Act
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER TEN PHARMACOVIGILANCE Section 62 Organisation of the pharmacovigilance system of the competent higher federal authority (1) In the interests of preventing direct or indirect hazards to human or animal health, it…
SPECIAL PROVISIONS FOR MEDICINAL PRODUCTS INTENDED FOR USE IN ANIMALS
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER NINE SPECIAL PROVISIONS FOR MEDICINAL PRODUCTS INTENDED FOR USE IN ANIMALS Section 56 Medicated feeding stuffs (1) By way of derogation from Section 47 sub-section 1, medicated feeding stuffs may only…
Safety and quality control
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER EIGHT Safety and quality control Section 54 Internal regulations (1) The Federal Ministry is hereby empowered to issue in agreement with the Federal Ministry for Economic Affairs and Energy, by ordinance…