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RTF Template

Bezirksregierung Koeln

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_NW_04_WDA_2025_0071-03
2. Name of Authorisation Holder	:	Cyclomedica Germany GmbH (ORG-100035540 / LOC-100100447)
3. Address(es) of Site(s)	:	Im Mediapark 5, Neustadt-Nord, Cologne, 50670, Germany

4. Legally registered address of Authorisation Holder	:	Im Mediapark 5, Neustadt-Nord, Cologne, 50670
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	:	2025-01-10
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: Cyclomedica Germany GmbH

(ORG-100035540 / LOC-100100447)

, Im Mediapark 5, Neustadt-Nord, Cologne, 50670, Germany

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

2.3. Supply

Any restrictions or clarifying remarks (for all users): The authorization is limited to the distribution of the Medicinal Product Pulmotec from Cyclomedica Ireland Limited.

Die Erlaubnis beschränkt sich auf das Streckengeschäft mit dem Arzneimittel Pulmotec der Cyclomedica Ireland Limited.

Union Format for a Wholesale Distribution Authorisation	DE_NW_04_WDA_2025_0071-03
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