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RTF Template

Ministry Of Social Affairs Health Women And Family

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_SL_01_WDA_2025_0007/501-018
2. Name of Authorisation Holder	:	CS-Pharma GmbH
3. Address(es) of Site(s)	:	Fabrikstr. 51, Homburg, 66424, Germany

4. Legally registered address of Authorisation Holder	:	Fabrikstr. 51, Homburg, 66424
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	:	2025-04-11
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: CS-Pharma GmbH

, Fabrikstr. 51, Homburg, 66424, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Any restrictions or clarifying remarks (for all users): The company CS-Pharma mainly deals with single imports of medicinal products according to § 73 (3) German Drug Law.

For the field of cytostatic drugs, this permission covers only oral dosage forms

Die Firma CS-Pharma befasst sich hauptsächlich mit Einzelimporten von Arzneimitteln nach § 73 Absatz 3 AMG.

Für den Bereich Zytostatika umfasst diese Erlaubnis nur orale Darreichungsformen.

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	DE_SL_01_WDA_2025_0007/501-018
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