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RTF Template

Regierungspraesidium Tuebingen, Leitstelle Arzneimittelueberwachung Baden-Wuerttemberg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_BW_01_WDA_2018_0001_ZKT
2. Name of Authorisation Holder	:	Zentrum für Klinische Transfusionsmedizin Tübingen gGmbH
3. Address(es) of Site(s)	:	Otfried-Müller-Str. 4/1, Tübingen, 72076, Germany Hoppe-Seyler-Str. 3, Tübingen, 72076, Germany

4. Legally registered address of Authorisation Holder	:	Otfried-Müller-Str. 4/1, Tübingen, 72076, Germany
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2018-11-08
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: Zentrum für Klinische Transfusionsmedizin Tübingen gGmbH

, Otfried-Müller-Str. 4/1, Tübingen, 72076, Germany

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

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.

Name and address of the site: ZKT Tübingen, Funktionsbereich Klinische Transfusionsmedizin, CRONA

, Hoppe-Seyler-Str. 3, Tübingen, 72076, Germany