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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_2024/ROB-55Ph- 2678.Ph_3-123-24-7
2. Name of Authorisation Holder	:	Import International Stefan Bauer Berthold Haberl Import internationaler Arzneimittel nach 73 3 AMG OHG (ORG-100038393 / LOC-100089958)
3. Address(es) of Site(s)	:	Dornbergstrasse 13, Berg Am Laim, Munich, Bavaria, 81673, Germany

4. Legally registered address of Authorisation Holder	:	Dornbergstrasse 13, Berg Am Laim, Munich, Bavaria, 81673
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-02-26
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: Import International Stefan Bauer Berthold Haberl Import internationaler Arzneimittel nach 73 3 AMG OHG

(ORG-100038393 / LOC-100089958)

, Dornbergstrasse 13, Berg Am Laim, Munich, Bavaria, 81673, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

2.5. Other activities(s): Import of medicinal products for human use pursuant to §73 3 AMG,transit of med. products pursuant to §73 2 no. 3a AMG, activities pursuant to §73 2 nos. 2, 2a AMG

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.1. Narcotic or psychotropic products

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Medicinal products requiring refrigeration

*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_BY_04_WDA_2024/ROB-55Ph- 2678.Ph_3-123-24-7
	Page 1

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