German law in plain text
Section 13 Manufacturing authorisation
(1) Any person who manufactures:
(...)
(2b) Furthermore, an authorisation pursuant to sub-section 1 shall not be required by a person who is a physician or otherwise authorised to practise medicine on humans in so far as the medicinal products are manufactured directly under his/her professional responsibility for personal use by a specific patient. (...)
- Medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1,
- Test sera, test antigens,
- Active substances, which are of human, animal or microbial origin or are manufactured using genetic engineering, or
- Other substances of human origin intended for the manufacture of medicinal products
(...)
(2b) Furthermore, an authorisation pursuant to sub-section 1 shall not be required by a person who is a physician or otherwise authorised to practise medicine on humans in so far as the medicinal products are manufactured directly under his/her professional responsibility for personal use by a specific patient. (...)
Section 67
(...)
(2) If medicinal product manufacture is envisaged, for which an authorisation as defined in Section 13 is not necessary, the medicinal products shall be notified indicating their name and composition.
(...)
(2) If medicinal product manufacture is envisaged, for which an authorisation as defined in Section 13 is not necessary, the medicinal products shall be notified indicating their name and composition.
(...)
