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RTF Template

Landesamt Fuer Gesundheit Und Soziales

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BE_01_WDA_2024_5373/1-HSM/03
2. Name of Authorisation Holder	:	Henry Schein Medical GmbH (ORG-100045090 / LOC-100090051)
3. Address(es) of Site(s)	:	Alt-Moabit 96 B, Tiergarten, Berlin, 10559, Germany

4. Legally registered address of Authorisation Holder	:	Alt-Moabit 96 B, Tiergarten, Berlin, 10559
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	§ 52a Arzneimittelgesetz (Medicinal Products Act)
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-04-02
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: Henry Schein Medical GmbH

(ORG-100045090 / LOC-100090051)

, Alt-Moabit 96 B, Tiergarten, Berlin, 10559, 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

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): The authorisation is based on the floor plan from 28.03.2024.
Supply only by drop shipment.
Only skin and hand desinfectants, infusion solutions according to § 47 (1) Nr. 2c Medicinal Products Act and medicinal gases.

Die Erlaubnis basiert auf dem Grundrissplan vom 28.03.2024.
Handel erfolgt im Streckengeschäft (Handel ohne Lagerung).
Das Sortiment beschränkt sich auf Desinfektionsmittel, Infusionslösungen nach § 47 Abs. 1 AMG und medizinische Gase.

*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_BE_01_WDA_2024_5373/1-HSM/03
	Page 1

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