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RTF Template

Landesverwaltungsamt Sachsen-Anhalt

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_ST_01_WDA_2023_019
2. Name of Authorisation Holder	:	Steinke Orthopaedie-Center GmbH (ORG-100037772 / LOC-100059618)
3. Address(es) of Site(s)	:	Am Bahndamm 7, Halberstadt, Saxony-Anhalt, 38820, Germany

4. Legally registered address of Authorisation Holder	:	Ueber Der Schlagmuehle 46, Halberstadt, Saxony-Anhalt, 38820
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	:	2023-07-25
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: Steinke Orthopaedie-Center GmbH

(ORG-100037772 / LOC-100089162)

, Am Bahndamm 7, Halberstadt, Saxony-Anhalt, 38820, 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

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): National legal basis of the authorisation: Section 52a subsection 1 Medicinal Products Act (AMG)
ref. 1.1: only skin and hand disinfectants, infusion solutions regulated in section 47 subsection 1 no. 2c AMG, medicinal oxygen (GOX) and solutions for parenteral nutrition
ref. 2.1 and 2.3: supply also by dropshipment
This WDA is based on the confirmend floor plan dated 19/09/2018.

Nationale Rechtsgrundlage der Erlaubnis: § 52a Abs. 1 Arzneimittelgesetz (AMG)
zu 1.1: nur Haut- und Händedesinfektionsmittel, Infusionslösungen nach § 47 Abs. 1 Nr. 2 c) AMG, medizinischer Sauerstoff und Lösungen zur parenteralen Ernährung
zu 2.1 und 2.3: auch Streckengeschäfte (Handel ohne Lagerung)
Die Erlaubnis basiert auf dem bestätigten Grundrissplan vom 19.09.2018

*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_ST_01_WDA_2023_019
	Page 1

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