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RTF Template

Government of Upper Bavaria - Central Authority for Supervision of Medicinal Products in Bavaria (GMP/GCP)

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_BY_04_WDA_2022/ ROB-55Ph-2677.Ph_2-120-40-2
2. Name of Authorisation Holder	:	Herbaria Krauterparadies GmbH (ORG-100002447 / LOC-100016951)
3. Address(es) of Site(s)	:	Hagnbergstraße 12, Hammer, Fischbachau, Bavaria, 83730, Germany

4. Legally registered address of Authorisation Holder	:	Hagnbergstraße 12, Hammer, Fischbachau, Bavaria, 83730
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	:	2022-06-22
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: Herbaria Krauterparadies GmbH

(ORG-100002447 / LOC-100016951)

, Hagnbergstraße 12, Hammer, Fischbachau, Bavaria, 83730, Germany

Human 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): 1.1: Permission is limited to trade in over-the-counter medicinal products.
2.2: Further storage facility s. Annex 2

1.1: Erlaubnis ist beschränkt auf den Handel mit freiverkäuflichen Arzneimitteln
2.2: Weitere Lagerstätte s. Anlage 2

*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_BY_04_WDA_2022/ ROB-55Ph-2677.Ph_2-120-40-2
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