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RTF Template

Regierung Von Oberfranken

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BY_05_WDA_2026_ROF-SG55.2-2675.3-96-4-13
2. Name of Authorisation Holder	:	Frigotherm e.K. (ORG-100036091 / LOC-100083027)
3. Address(es) of Site(s)	:	Friedrich-Bauer-Strasse 2a, Erlangen-Sued, Erlangen, 91058, Germany

4. Legally registered address of Authorisation Holder	:	Friedrich-Bauer-Strasse 2a, Erlangen-Sued, Erlangen, 91058
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	:	2026-08-11
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: Frigotherm e.K.

(ORG-100036091 / LOC-100083027)

, Friedrich-Bauer-Strasse 2a, Erlangen-Sued, Erlangen, 91058, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

Union Format for a Wholesale Distribution Authorisation	DE_BY_05_WDA_2026_ROF-SG55.2-2675.3-96-4-13
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