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RTF Template

Department of drug and pharmacy supervision

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	DE_ST_01_WDA_2021_006
2. Name of Authorisation Holder	:	Westfalen AG
3. Address(es) of Site(s)	:	An der Tonkuhle 11, Stadt Wanzleben-Börde, 39164, Germany

4. Legally registered address of Authorisation Holder	:	Industrieweg 43, Münster, 48155, Germany
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-08-23
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: Westfalen AG

, An der Tonkuhle 11, Stadt Wanzleben-Börde, 39164, Germany

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

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 authorisation: Section 52a (1) German Drug Law (Arzneimittelgesetz - AMG),
- ref. 1.1: only medicinal gases,
- wholesale activities in the premises according to the present site plan Nr. 1 from 30.08.2018.

- Nationale Rechtsgrundlage für die Erlaubnis: § 52a (1) Arzneimittelgesetz (AMG),
- zu 1.1: nur medizinische Gase,
- Großhandelsaktivitäten in den Räumen gemäß dem genehmigten Lageplan Nr. 1 vom 30.08.2018.

Union Format for a Wholesale Distribution Authorisation	DE_ST_01_WDA_2021_006
	Page 1

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