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.…
Empowerment in respect of labelling, package leaflet and package sizes. Requirements on medicinal products
Medicinal Products Act (Laws / Regulations of Germany) Section 12 Empowerment in respect of labelling, package leaflet and package sizes (1) The Federal Ministry is hereby empowered, in agreement with the Federal Ministry for Economic Affairs and Energy by ordinance…
Expert information. Requirements on medicinal products
Medicinal Products Act (Laws / Regulations of Germany) Section 11a Expert information (1) The pharmaceutical entrepreneur shall be obliged to make available upon request to physicians, dentists, veterinarians, pharmacists and, if the medicinal products concerned are not subject to prescription,…
Package leaflet. Requirements on medicinal products
Medicinal Products Act (Laws / Regulations of Germany) Section 11 Package leaflet (1) Finished medicinal products that are medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1 and are intended neither for clinical trial…
Labelling. Requirements on medicinal products
Medicinal Products Act (Laws / Regulations of Germany) Section 10 Labelling (1) Finished medicinal products that are medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1, and are not intended for clinical trials on…