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RTF Template

Regierungspraesidium Freiburg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_04_WDA_2025_0007
2. Name of Authorisation Holder	:	AKcess Pharma GmbH (ORG-100052069 / LOC-100091613)
3. Address(es) of Site(s)	:	Mitscherlichstrasse 8, Bruehl, Freiburg Im Breisgau, Baden-Wuerttemberg, 79108, Germany

4. Legally registered address of Authorisation Holder	:	Mitscherlichstrasse 8, Bruehl, Freiburg Im Breisgau, Baden-Wuerttemberg, 79108
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	:	2025-07-15
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: AKcess Pharma GmbH

(ORG-100052069 / LOC-100091613)

, Mitscherlichstrasse 8, Bruehl, Freiburg Im Breisgau, Baden-Wuerttemberg, 79108, 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

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) Holding at "Med-X-Press GmbH" adress see belowLagerung bei „Med-X-Press GmbH" Adresse siehe unten

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): Holding at „Med-X-Press GmbH"
Alte Heerstraße 9, 38644 Goslar and
Dörntener Straße 21, 38644 Goslar

Lagerung beim Logistikdienstleister „Med-X-Press GmbH"
Alte Heerstraße 9, 38644 Goslar und
Dörntener Straße 21, 38644 Goslar

Union Format for a Wholesale Distribution Authorisation	DE_BW_04_WDA_2025_0007
	Page 1

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