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RTF Template

Austrian Agency For Health And Food Safety

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	482070
2. Name of Authorisation Holder	:	Medice Arzneimittel GmbH (ORG-100020299 / LOC-100102952)
3. Address(es) of Site(s)	:	Dornbacher Strasse 49/1, Hernals, Vienna, 1170, Austria

4. Legally registered address of Authorisation Holder	:	Dornbacher Strasse 49/1, Hernals, Vienna, 1170
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2026-05-21
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: Medice Arzneimittel GmbH

(ORG-100020299 / LOC-100102952)

, Dornbacher Strasse 49/1, Hernals, Vienna, 1170, Austria

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration 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. Narcotic or psychotropic products**

Any restrictions or clarifying remarks (for all users): Medice Arzneimittel GmbH; Ad 2.2 „Lagerung" eingeschränkt auf die Lagerung von Ärztemustern bei Außendienstpersonal / Regarding 2.2. „Holding" restricted to the storage of medical samples at sales representatives Betreffend Inspektionsverfahren INS-482070-104301640 Probebetrieb bis zum / Regarding inspection case INS-482070-104301640 valid until: 30.09.2028

Medice Arzneimittel GmbH; Ad 2.2 „Lagerung" eingeschränkt auf die Lagerung von Ärztemustern bei Außendienstpersonal / Regarding 2.2. „Holding" restricted to the storage of medical samples at sales representatives Betreffend Inspektionsverfahren INS-482070-104301640 Probebetrieb bis zum / Regarding inspection case INS-482070-104301640 valid until: 30.09.2028

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

Union Format for a Wholesale Distribution Authorisation	482070
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