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RTF Template

Landesdirektion Sachsen LDS

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products and Veterinary medicinal products

1. Authorisation Number	:	DE_SN_01_WDA_2024_0006
2. Name of Authorisation Holder	:	Apo.Com Group GmbH (ORG-100017739 / LOC-100026493)
3. Address(es) of Site(s)	:	Magdeborner Strasse 14, Wachau, Markkleeberg, Saxony, 04416, Germany

4. Legally registered address of Authorisation Holder	:	Magdeborner Strasse 14, Wachau, Markkleeberg, Saxony, 04416
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 Art. 99 of Regulation (EU) 2019/6
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-04-22
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: Apo.Com Group GmbH

(ORG-100017739 / LOC-100026493)

, Magdeborner Strasse 14, Wachau, Markkleeberg, Saxony, 04416, Germany

Human medicinal products

Veterinary medicinal products

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

Any restrictions or clarifying remarks (for all users): This authorisation does not apply to the wholesale of medicinal products to be stored cold and deep-frozen. The wholesale trade in veterinary medicinal products is limited to non-prescription veterinary medicinal products, insofar as these are intended for use in non-food-producing animals.

Diese Erlaubnis gilt nicht für den Großhandel mit kühl und tiefgekühlt zu lagernden Arzneimitteln. Der Großhandel mit Tierarzneimitteln beschränkt sich auf nicht verschreibungspflichtige Tierarzneimittel, soweit diese zur Anwendung bei nicht Lebensmittel liefernden Tieren vorgesehen ist.

*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_WDA_2024_0006
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