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RTF Template

Austrian Agency For Health And Food Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	481146
2. Name of Authorisation Holder	:	Amex Healthcare GmbH (ORG-100036555 / LOC-100070020)
3. Address(es) of Site(s)	:	Heiligenstaedter Strasse 31/3, Vienna, 1190, Austria

4. Legally registered address of Authorisation Holder	:	Heiligenstaedter Strasse 31/3, Vienna, 1190
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2016-09-23
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: Amex Healthcare GmbH

(ORG-100036555 / LOC-100070020)

, Heiligenstaedter Strasse 31/3, Vienna, 1190, Austria

Human medicinal products

Veterinary medicinal products

1. MEDICINAL PRODUCTS

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

1.3. without a Marketing Authorisation or registration in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

2.5. Other activities(s): (please specify) Vertrieb von Arzneimitteln aus einem Drittstaat in einem einen anderen Drittstaat/ distribution of …Vertrieb von Arzneimitteln aus einem Drittstaat in einem einen anderen Drittstaat/ distribution of …

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1. Narcotic or psychotropic products**

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): Amex Healthcare GmbH; Ad 2.3 Betriebsbewilligung Arzneimittel Großhändler / Wholesale Distribution Authorisation for Medicinal Products: Eingeschränkt auf die Ausfuhr von Arzneimitteln / Restricted to the export of medicinal products

Amex Healthcare GmbH; Ad 2.3 Betriebsbewilligung Arzneimittel Großhändler / Wholesale Distribution Authorisation for Medicinal Products: Eingeschränkt auf die Ausfuhr von Arzneimitteln / Restricted to the export of medicinal products

**Without prejudice to further authorisations as may be required according to national legislation.

Union Format for a Wholesale Distribution Authorisation	481146
	Page 1

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