German Law

German law in plain text

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. 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.

(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.


That means in plain text: (WITHIN GERMANY)

Own manufacture is allowed

You produce in cooperation with our partner laboratory the necessary medicines according to your needs.

Only for your own patients within the practice

The medicinal products manufactured by you must not be administered outside of your area of responsibility.

Placing on the market is prohibited

You may not resell the drugs manufactured by you.

Registration with the local authority as a self-producer

This is a requirement of the legislator which is obligatory for all cell therapists