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RTF Template

Regierungspresidium Tubingen, Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BW_01_WDA_2023_0001_IKT Ulm
2. Name of Authorisation Holder	:	Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH (ORG-100020242 / LOC-100028999)
3. Address(es) of Site(s)	:	Helmholtzstrasse 10, Eselsberg, Ulm, Baden-Wuerttemberg, 89081, Germany

4. Legally registered address of Authorisation Holder	:	Helmholtzstrasse 10, Eselsberg, Ulm, Baden-Wuerttemberg, 89081
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-02-15
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: Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH

(ORG-100020242 / LOC-100028999)

, Helmholtzstrasse 10, Eselsberg, Ulm, Baden-Wuerttemberg, 89081, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

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): The storage and transport of cold chain medicines are limited to medicines derived from blood.

Die Lagerung und der Transport von kühlkettenpflichtigen Arzneimitteln sind auf Arzneimittel aus Blut beschränkt.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Union Format for a Wholesale Distribution Authorisation	DE_BW_01_WDA_2023_0001_IKT Ulm
	Page 1

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