German Law

(1) Any person who manufactures:

1. Medicinal products within the meaning of Section 2 sub-section 1 or sub-section 2 number 1,
2. Test sera, test antigens,
3. Active substances, which are of human, animal or microbial origin or are manufactured using genetic engineering, or
4. Other substances of human origin intended for the manufacture of medicinal products

on a commercial or professional basis shall require an authorisation by the competent authority. The same shall also apply to legal persons, non-incorporated associations and companies established under civil law which manufacture medicinal products for distribution to their members. Sentence 1 shall apply mutatis mutandis to a trial on the basis of which the release of the medicinal product is explained. This shall be without prejudice to Section 14 sub-section 4.

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(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. (...)

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(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.
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