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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_2018_037
2. Name of Authorisation Holder	:	Großhandel Zur Rose
3. Address(es) of Site(s)	:	Thüringer Straße 29, Halle (Saale), 06112, Germany

4. Legally registered address of Authorisation Holder	:	Thüringer Straße 29, Halle (Saale), 06112, 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	:	2018-11-01
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: Großhandel Zur Rose

, Thüringer Straße 29, Halle (Saale), 06112, Germany

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): The wholesale is carried out in the premises according to the present site plans dated 28.07.2015.
The wholesale is operated only for the purpose of supplying the wholesaler Zur Rose Pharma GmbH.
National legal basis of authorisation: Section 52a (1) German Drug Law (Arzneimittelgesetz - AMG).

Der Großhandel wird in den Räumen gemäß des vorliegenden Lageplanes vom 28.07.2015 durchgeführt.
Der Großhandel wird ausschließlich zum Zwecke der Belieferung des Großhändlers Zur Rose Pharma GmbH betrieben.
Nationale Rechtsgrundlage für die Erlaubnis: § 52a Abs. 1 des Arzneimittelgesetzes (AMG).

Union Format for a Wholesale Distribution Authorisation	DE_ST_01_WDA_2018_037
	Page 1

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