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RTF Template

Landesdirektion Sachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SN_01/L24.2-5117/158
2. Name of Authorisation Holder	:	first medical gmbh
3. Address(es) of Site(s)	:	An der Morgensonne 2, Geyer, 09468, Germany

4. Legally registered address of Authorisation Holder	:	An der Morgensonne 2, Geyer, 09468, 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	:	2018-09-10
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: first medical gmbh

, An der Morgensonne 2, Geyer, 09468, 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

2.4. Export

Any restrictions or clarifying remarks (for all users): This authorisation is limited to infusion solutions intended for the replacement or the correction of body fluid, and disinfectants. It is limited to infusion solutions and disinfectants which do not need to be stored under "cool", "cold" or "freezer" conditions.

Products may also be stored in a warehouse located in 09429 Wolkenstein (Falkenbach hamlet), Hauptstraße 12. They may be delivered directly to this site.

Diese Erlaubnis gilt nur für den Großhandel mit Desinfektionsmitteln sowie mit Infusionslösungen, die zum Ersatz oder zur Korrektur von Körperflüssigkeit bestimmt sind. Sie gilt dabei ausschließlich für Desinfektionsmittel und Infusionslösungen, die nicht kühl oder tiefgekühlt zu lagern sind.

Die Lagerung und die Abgabe von Arzneimitteln dürfen auch in der Betriebsstätte in 09429 Wolkenstein (Ortsteil Falkenbach), Hauptstraße 12, erfolgen. Die Anlieferung von Arzneimittel darf in diese Betriebsstätte erfolgen.

*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/L24.2-5117/158
	Page 1

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