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RTF Template

Regierungspraesidium Darmstadt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_HE_01_WDA_2022_0036
2. Name of Authorisation Holder	:	Sinceritas GmbH (ORG-100042482 / LOC-100070179)
3. Address(es) of Site(s)	:	Alte Sattelfabrik 3, Kirdorf, Bad Homburg, 61350, Germany

4. Legally registered address of Authorisation Holder	:	Alte Sattelfabrik 3, Kirdorf, Bad Homburg, 61350
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Sect 52a para 1 German Medicinal Product Act
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2023-05-15
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: Sinceritas GmbH

(ORG-100042482 / LOC-100070179)

, Alte Sattelfabrik 3, Kirdorf, Bad Homburg, 61350, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.5. Other activities(s): drop shipment, brokering of med. products, holding & supply as outsouced activity (see Annex 2)Streckengesch., Arzneimittelverm., Lagerung & Lieferung (Abg.) durch beauftr. Großhändler (Anl. 2)

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

Any restrictions or clarifying remarks (for all users): none

keine

*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_HE_01_WDA_2022_0036
	Page 1

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