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…
Category: Laws / Regulations of Germany
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…
Sale of medicinal products
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER SEVEN Sale of medicinal products Section 43 Pharmacy-only requirement, placing on the market by veterinarians (1) Medicinal products as defined in Section 2 sub-section 1 or sub-section 2 number 1, which…
Protection of human subjects in clinical trials
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER SIX Protection of human subjects in clinical trials Section 40 General conditions for clinical trials (1) The sponsor, the investigator and all of the other persons involved in the clinical trial…
Registration of medicinal products
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER FIVE Registration of medicinal products Section 38 Registration of homeopathic medicinal products (1) Finished medicinal products that are medicinal products as defined in Section 2 sub-section 1 or sub-section 2 number…
Marketing authorisation of medicinal products
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER FOUR Marketing authorisation of medicinal products Section 21 Obligation to obtain a marketing authorisation (1) Finished medicinal products that are medicinal products as defined in Section 2 sub-section 1 or sub-section…
Authorisation for the procurement of tissues and the pertinent laboratory testing
Medicinal Products Act (Laws / Regulations of Germany) Section 20b Authorisation for the procurement of tissues and the pertinent laboratory testing (1) Any establishment seeking to procure tissues intended for human applications within the meaning of Section 1a number 4…
Manufacture of medicinal products
Medicinal Products Act (Laws / Regulations of Germany) CHAPTER THREE Manufacture of medicinal products Section 13 Manufacturing authorisation (1) Any person who manufactures: 1. medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1, 2.…