Permit to carry out procedures for achieving pregnancy

• Approval procedure The approval is granted through a permit procedure that requires an application and is subject to a fee. The necessary application form will be sent on request. The application must be submitted in writing. Certified copies must be enclosed as proof of the requirements listed below.

• Future holders of the authorization and their deputies must provide proof of: • Approbation (medical license) • Facharztanerkennung (specialist recognition) in gynecology and obstetrics with a focus on endocrinology and reproductive medicine • Abrechnungsgenehmigungen (billing authorizations) for reproductive endocrinology, gynecological sonography, operative gynecology, andrology, basic psychosomatic care, • Vertragsärztliche Genehmigung (statutory health insurance panel physician authorization) or Ermächtigung (special authorization) • Cooperation agreements with: human genetics, psychotherapy, and morphological sperm diagnostics; • Floor plan of the facility with equipment and furnishings

The approval procedure is subject to a fee (Gebühr). Fees are charged in accordance with the Verordnung über die Erhebung von Gebühren im Gesundheits- und Sozialwesen sowie Arbeits- und gesundheitlichen Verbraucherschutz (Ordinance on the Levying of Fees in Health and Social Affairs and Occupational and Health-Related Consumer Protection), as amended. The obligation to pay the fee arises upon submission of the application and does NOT depend on whether the permit is actually granted.

• a) § 121a SGB V (Social Code Book V) (for the approval) www.sozialgesetzbuch-sgb.de/sgbv/121a.html • b) AMG – Arzneimittelgesetz (Medicines Act) §§ 20b and 20c (for the permit) www.gesetze-im-internet.de/amg_1976/ • c) § 27a para. 1 and 2 SGB V www.gesetze-im-internet.de/sgb_5/__27a.html • d) Guidelines of the Gemeinsamer Bundesausschuss (Federal Joint Committee, G-BA) on medical measures for artificial insemination www.g-ba.de/richtlinien/1/

In Berlin, the approval procedure under SGB V §121a (Social Code Book V) is handled by the Landesamt für Gesundheit und Soziales (State Office for Health and Social Affairs) - Department I, Section I F - in the area of reproductive medicine. The responsible contact person can be reached at (030)90229-2305. The permit procedure under AMG §§20b and 20c (Medicines Act) is handled in Berlin by the Landesamt für Gesundheit und Soziales (State Office for Health and Social Affairs) - Department I, Section I F - in the area of medicinal products. The responsible contact person can be reached at (030)90229-2912.