1. Authorisation Number

:

DE_SH_01_WDA_2024_0004

2. Name of Authorisation Holder

:

Merz Dental GmbH

(ORG-100003072 / LOC-100028531)

3. Address(es) of Site(s)

:

Kieferweg 1, Luetjenburg, Schleswig-Holstein, 24321, Germany 

4. Legally registered address of Authorisation Holder

:

Kieferweg 1, Luetjenburg, Schleswig-Holstein, 24321

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

:

2024-03-21

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

Name and address of the site: Merz Dental GmbH

(ORG-100003072 / LOC-100028531)

, Kieferweg 1, Luetjenburg, Schleswig-Holstein, 24321, Germany   

Human medicinal products

Any restrictions or clarifying remarks (for all users):  Medicinal products for human use with marketing authorisation in a country of the European Economic Area
- Finished medicinal products for dentists pursuant to Section 47 para. 1 no. 7 AMG (dental medicinal products)
- Hand and skin disinfectants

Humanarzneimittel mit Erlaubnis zum Inverkehrbringen in einem Staat des Europäischen Wirtschaftsraumes
- Fertigarzneimittel für Zahnärzte gemäß § 47 Abs. 1 Nr. 7 AMG (Dentalarzneimittel)
- Hände- und Hautdesinfektionsmittel

*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_SH_01_WDA_2024_0004

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