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RTF Template

Regierungspraesidium Tuebingen Pharmazeutische Angelegenheiten

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_05_WDA_2024_0004
2. Name of Authorisation Holder	:	Recordati Rare Diseases Germany GmbH (ORG-100034381 / LOC-100054504)
3. Address(es) of Site(s)	:	Eberhard-Finckh-Straße 55, Ulm, 89075, Germany

4. Legally registered address of Authorisation Holder	:	Eberhard-Finckh-Strasse 55, Boefingen, Ulm, Baden-Wuerttemberg, 89075
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	:	2024-03-01
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: Recordati Rare Diseases Germany GmbH

, Eberhard-Finckh-Straße 55, Ulm, 89075, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.3. Supply

2.5. Other activities(s): siehe untensee below

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Ref. 2.5: Third-party storage by the wholesaler Pharmore GmbH, Gildestraße 74, 49479 Ibbenbüren (The medicinal products are stored exclusively at: Health Logistics GmbH, Vichystraße 14, 76646 Bruchsal).
This wholesale distribution authorisation is based on the ground floor plans sent on 13th of March 2023 and comprise the room 034 in the ground floor (dated on 7th of March 2023).

Zu 2.5: Lohnlagerung durch den Großhandelsbetrieb Pharmore GmbH, Gildestraße 74, 49479 Ibbenbüren (Lagerung der Ware erfolgt ausschließlich bei: Health Logistics GmbH, Vichystraße 14, 76646 Bruchsal).
Die Erlaubnis basiert auf den am 13.03.2023 übersandten Grundrissplan und umfasst im Erdgeschoss den Raum 034 (Stand: 07.03.2023).

Union Format for a Wholesale Distribution Authorisation	DE_BW_05_WDA_2024_0004
	Page 1

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