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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_2024_0001_BeiGene
2. Name of Authorisation Holder	:	BeiGene Germany GmbH (ORG-100034947 / LOC-100064075)
3. Address(es) of Site(s)	:	Georges-Koehler-Strasse 2, Loerrach, Baden-Wuerttemberg, 79539, Germany

4. Legally registered address of Authorisation Holder	:	Georges-Koehler-Strasse 2, Loerrach, Baden-Wuerttemberg, 79539
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	:	13.05.2024
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: BeiGene Germany GmbH

(ORG-100034947 / LOC-100064075)

, Georges-Koehler-Strasse 2, Loerrach, Baden-Wuerttemberg, 79539, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.5. Other activities(s): Drop shipment only, no procurement, storage or delivery

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): on point 2.5.:
The authorization is limited to the products "Brukinsa" and "Tevimbra" in various strengths and dosage sizes.

zu Punkt 2.5.:
Die Erlaubnis beschränkt sich auf die Produkte „Brukinsa" und "Tevimbra" in verschiedenen Stärken und Darreichungsgrößen.

Union Format for a Wholesale Distribution Authorisation	DE_BW_01_WDA_2024_0001_BeiGene
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