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RTF Template

State Office of Health and Social Affairs Berlin

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	5373/1/01 – Dr. Robert Winzer Pharma GmbH/02
2. Name of Authorisation Holder	:	Dr. Robert Winzer Pharma GmbH (ORG-100001107 / LOC-100001607)
3. Address(es) of Site(s)	:	Brunsbuetteler Damm 165 - 173, Spandau, Berlin, 13581, Germany

4. Legally registered address of Authorisation Holder	:	Brunsbuetteler Damm 165 - 173, Spandau, Berlin, 13581
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2022-03-18
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: Dr. Robert Winzer Pharma GmbH

(ORG-100001107 / LOC-100001607)

, Brunsbuetteler Damm 165 - 173, Spandau, Berlin, 13581, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

Any restrictions or clarifying remarks (for all users): This authorization is based on floor plan from 2022-01-25 related to room 1.131. Only trade of ophthalmic medicinal products in case Dr. Robert Winzer Pharma GmbH is co-distributor noted in marketing authorization of the products. Marketing authorization holder of these products is only Dr. Gerhard Mann chem.-pharm. Fabrik GmbH. Physical handling of these products is not performed.

Die Erlaubnis beruht auf den beigefügten Lageplan vom 25.01.2022 und bezieht sich auf den Raum 1.131. Es erfolgt ausschließlich Handel mit Augenarzneimitteln, bei denen die Erlaubnisinhaberin auch als Mitvertreiberin in der Zulassung geführt wird. Zulassungsinhaberin bei den zu handelnden Produkten ist die Dr. Gerhard Mann chem.-pharm. Fabrik GmbH. Es erfolgt kein physischer Umgang mit den genannten Arzneimitteln.

*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	5373/1/01 – Dr. Robert Winzer Pharma GmbH/02
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