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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_2019_0001_IL-CSM
2. Name of Authorisation Holder	:	IL CSM Clinical Supplies Management GmbH
3. Address(es) of Site(s)	:	Marie-Curie-Str. 8, Loerrach, Baden-Wuerttemberg, 79539, Germany

4. Legally registered address of Authorisation Holder	:	Marie-Curie-Str. 8, Loerrach, Baden-Wuerttemberg, 79539, 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	:	2019-09-10
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: IL CSM Clinical Supplies Management

, Marie-Curie-Str. 8, Loerrach, Baden-Wuerttemberg, 79539, 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

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): contract site for storage: Grieshaber Logistics Group AG, Warmbacher Strasse 80, D-79618 Rheinfelden

Ort der Lagerung (im Auftrag): Grieshaber Logistics Group AG, Warmbacher Strasse 80, D-79618 Rheinfelden

*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_2019_0001_IL-CSM
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