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RTF Template

Landesdirektion Sachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SN_01/L24.2-5117/173
2. Name of Authorisation Holder	:	Bönig Dental GmbH
3. Address(es) of Site(s)	:	Forststraße 46, Plauen, 08523, Germany

4. Legally registered address of Authorisation Holder	:	Geisfelder Straße 14, Bamberg, 96050, Germany
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2019-03-15
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: Bönig Dental GmbH

, Forststraße 46, Plauen, 08523, Germany

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

Any restrictions or clarifying remarks (for all users): This authorisation is limited to procurement. Any holding or other physical handling of medicinal products is not allowed.

Diese Erlaubnis gilt nur die Beschaffung von Arzneimitteln. Eine Lagerung von Arzneimitteln ist ebenso wie jeder sonstige körperliche Umgang mit ihnen nicht zulässig.

*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_SN_01/L24.2-5117/173
	Page 1

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