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RTF Template

Regierungspraesidium Tuebingen Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_01_WDA_2025_0001_Apofaktur
2. Name of Authorisation Holder	:	Apofaktur GmbH (ORG-100051521 / LOC-100090379)
3. Address(es) of Site(s)	:	Bahnhofstrasse 52, Fellbach, Baden-Wuerttemberg, 70734, Germany Bahnhofstrasse 5, Nuertingen, Baden-Wuerttemberg, 72622, Germany

4. Legally registered address of Authorisation Holder	:	Bahnhofstrasse 52, Fellbach, Baden-Wuerttemberg, 70734, Germany
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-02-11
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Apofaktur GmbH

(ORG-100051521 / LOC-100090379)

, Bahnhofstrasse 52, Fellbach, Baden-Wuerttemberg, 70734, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.5. Other activities(s): (please specify) Trade/InvoicingHandel/Rechnungsstellung

Any restrictions or clarifying remarks (for all users): limited to solid dosage forms for oral use

beschränkt auf feste Darreichungsformen zur oralen Einnahme

Name and address of the site: Apofaktur GmbH

(ORG-100051521 / LOC-100090493)

, Bahnhofstrasse 5, Nuertingen, Baden-Wuerttemberg, 72622, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

Any restrictions or clarifying remarks (for all users): limited to solid dosage forms for oral use

beschränkt auf feste Darreichungsformen zur oralen Einnahme

Union Format for a Wholesale Distribution Authorisation	DE_BW_01_WDA_2025_0001_Apofaktur
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