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RTF Template

Regierung Von Oberbayern

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BY_04_WDA_2025/ROB-55Ph- 2678.Ph_2-136-42-13
2. Name of Authorisation Holder	:	Organon Healthcare GmbH (ORG-100031480 / LOC-100089362)
3. Address(es) of Site(s)	:	Pestalozzistrasse 31, Ludwigsvorstadt-Isarvorstadt, Munich, 80469, Germany

4. Legally registered address of Authorisation Holder	:	Pestalozzistrasse 31, Ludwigsvorstadt-Isarvorstadt, Munich, Bavaria, 80469
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	:	2025-11-10
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: Organon Healthcare GmbH

(ORG-100031480 / LOC-100089362)

, Pestalozzistrasse 31, Ludwigsvorstadt-Isarvorstadt, Munich, 80469, 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

2.5. Other activities(s): (please specify) Pharmaceutical company

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.3. Other products: (please specify here or make a reference to Annex 5) Medicines requiring refrigeration

Any restrictions or clarifying remarks (for all users): Re 2.2: Storage is carried out by an external service provider (see Appendix 2).

Zu 2.2: Lagerung erfolgt durch externen Dienstleister (s. Anlage 2)

Union Format for a Wholesale Distribution Authorisation	DE_BY_04_WDA_2025/ROB-55Ph- 2678.Ph_2-136-42-13
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