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RTF Template

Bezirksregierung Düsseldorf

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_NW_03_WDA_2018_0024/24.05.05.01-Sangro
2. Name of Authorisation Holder	:	Sangro Medical Service GmbH
3. Address(es) of Site(s)	:	Albert-Einstein-Str. 2, Erkrath, 40699, Germany

4. Legally registered address of Authorisation Holder	:	Albert-Einstein-Str. 2, Erkrath, 40699, 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	:	2018-06-25
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: Sangro Medical Service GmbH

, Albert-Einstein-Str. 2, Erkrath, 40699, Germany

1. MEDICINAL PRODUCTS

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

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

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The scope of this certificate includes the storage of medicinal products at ambient temperature (15-25°C), respectively cold storage (2-8°C) in the site mentioned above.

Erlaubnis wird mit der Einschränkung erteilt, dass ausschließlich die Lagerung in der oben genannten Betriebsstätte erlaubt ist, deren erforderliche Lagertemperatur im Bereich Kühllagerung (2-8°C) bzw. im Bereich Raumtemperatur (15-25°C) liegt.

*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_NW_03_WDA_2018_0024/24.05.05.01-Sangro
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