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RTF Template

Landesdirektion Sachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SN_01/26-5117/5
2. Name of Authorisation Holder	:	AMS Analytik & Medizinservice GmbH
3. Address(es) of Site(s)	:	Köhlerstraße 14a, Dresden, 01239, Germany

4. Legally registered address of Authorisation Holder	:	Köhlerstraße 14a, Dresden, 01239, 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	:	2019-07-04
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: AMS Analytik & Medizinservice GmbH

, Köhlerstraße 14a, Dresden, 01239, 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

Any restrictions or clarifying remarks (for all users): This authorisation only applies to the wholesale of infusion solutions in containers of at least 500 ml and disinfectants which do not need to be stored under "cool", "cold" or "freezer" condition.

Diese Erlaubnis gilt nur für den Großhandel mit Infusionslösungen in Behältnissen ab 500 ml und Desinfektionsmitteln, die nicht kühl oder tiefgekühlt zu lagern sind.

*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_SN_01/26-5117/5
	Page 1

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