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RTF Template

Behoerde Fuer Gesundheit Und Verbraucherschutz Der Freien Und Hansestadt Hamburg

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_HH_01_WDA/517-02.13/01,042
2. Name of Authorisation Holder	:	Dentina GmbH (ORG-100042762 / LOC-100081335)
3. Address(es) of Site(s)	:	Tarpen 40, Langenhorn, Hamburg, 22419, Germany

4. Legally registered address of Authorisation Holder	:	Tarpen 40, Langenhorn, Hamburg, 22419
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	:	2023-07-11
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: Dentina GmbH

(ORG-100042762 / LOC-100081335)

, Tarpen 40, Langenhorn, Hamburg, 22419, Germany

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.3. Supply

2.5. Other activities(s): Storage at a commissioned companyLagerung bei einem beauftragtem Betrieb

Any restrictions or clarifying remarks (for all users): Ref 1.1: Only skin and hand disinfectants as well as finished medicinal products exclusively for dentistry (Section 47 (1) No. 7 of the German Medicines Act).

Zu 1.1: Nur Haut- und Händedesinfektionsmittel sowie Fertigarzneimittel ausschließlich zur Zahnheilkunde (§47 Abs. 1 Nr. 7 Arzneimittelgesetz)

*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_HH_01_WDA/517-02.13/01,042
	Page 1

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