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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_3-355-9-13
2. Name of Authorisation Holder	:	Otomed Pharma GmbH (ORG-100035325 / LOC-100056018)
3. Address(es) of Site(s)	:	Feringastrasse 9a, Unterfoehring, Bavaria, 85774, Germany

4. Legally registered address of Authorisation Holder	:	Feringastrasse 9a, Unterfoehring, Bavaria, 85774
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	:	2025-11-17
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: Otomed Pharma GmbH

(ORG-100035325 / LOC-100056018)

, Feringastrasse 9a, Unterfoehring, Bavaria, 85774, 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

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Other products: (please specify here or make a reference to Annex 5) Medicines derived from blood, immunological drugs medicines requiring refrigeration and cold chain storage

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

zu 2.2: Lagerung erfolgt zusätzlich durch externen Dienstleister (s. Anl. 2)

Union Format for a Wholesale Distribution Authorisation	DE_BY_04_WDA_2025/ ROB-55Ph-2678.Ph_3-355-9-13
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