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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_2026-0103-01
2. Name of Authorisation Holder	:	Septodont GmbH (ORG-100004547 / LOC-100004645)
3. Address(es) of Site(s)	:	Felix-Wankel-Str. 9, Niederkassel, 53859, Germany

4. Legally registered address of Authorisation Holder	:	Felix-Wankel-Strasse 9, Mondorf, Niederkassel, North Rhine-Westphalia, 53859
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	:	2026-05-11
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: SEPTODONT GmbH

, Felix-Wankel-Str. 9, Niederkassel, 53859, 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

Any restrictions or clarifying remarks (for all users): to 1.1. finished medicinal products used exclusively in the field of dentistry (section 47 subsection 1 number 7 Medicinal Products Act (Arzneimittelgesetz))

zu 1.1. Fertigarzneimittel die ausschließlich in der Zahnheilkunde verwendet werden (§47 Abs. 1 Nr. 7 AMG)

Union Format for a Wholesale Distribution Authorisation	DE_NW_04_WDA_2026-0103-01
	Page 1

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