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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_014
2. Name of Authorisation Holder	:	Halle Sanitaetshaus GmbH (ORG-100036466 / LOC-100057659)
3. Address(es) of Site(s)	:	Neustaedter Passage 9, Noerdliche Neustadt, Halle (Saale), 06122, Germany

4. Legally registered address of Authorisation Holder	:	Neustaedter Passage 9, Noerdliche Neustadt, Halle (Saale), 06122
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	:	2023-06-13
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: Halle Sanitaetshaus GmbH

(ORG-100036466 / LOC-100057659)

, Neustaedter Passage 9, Noerdliche Neustadt, Halle (Saale), 06122, 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 (1) German Drug Law (AMG)
ref. 1.1: only skin and hand disinfectants and medicinal oxygen
ref. 2.3: sale exclusively to doctors
This WDA is based on the confirmed floor plan dated 01/12/2005.

Nationale Rechtsgrundlage der Erlaubnis: § 52a (1) Arzneimittelgesetz (AMG)
zu 1.1: nur Haut- und Händedesinfektionsmittel und medizinischer Sauerstoff
zu 2.3: Abgabe nur an Ärzte
Die Erlaubnis basiert auf dem bestätigten Grundrissplan vom 01.12.2005.

*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_014
	Page 1

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