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RTF Template

Landesdirektion Sachsen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_SN_01/L24.2-5117/282
2. Name of Authorisation Holder	:	Angela Stimmel
3. Address(es) of Site(s)	:	Hofer Straße 16b, Oelsnitz, 08606, Germany

4. Legally registered address of Authorisation Holder	:	Hofer Straße 16b, Oelsnitz, 08606, 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	:	2019-01-31
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: Dentalhandel Angela Stimmel

, Hofer Straße 16b, Oelsnitz, 08606, Germany

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Relating to medicinal products which must be stored in a refrigerator or in a freezer, this authorisation is limited to procurement, supply and export. Holding, storing and any other physical handling of these medicinal products are not allowed in the site.

Diese Erlaubnis umfasst in Bezug auf kühl oder tiefgekühlt zu lagernde Arzneimittel nur die Erlaubnis zur Beschaffung, Lieferung und Ausfuhr. Eine Lagerung dieser Arzneimittel in der Betriebsstätte in Oelsnitz, Hofer Straße 16b, ist ebenso wie jeder sonstige körperliche Umgang mit diesen Arzneimitteln dort 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/L24.2-5117/282
	Page 1

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