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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_006
2. Name of Authorisation Holder	:	SKmed Joachim Knabe, Medizinischer Fachhandel
3. Address(es) of Site(s)	:	Oberröblinger Bahnhofstr. 1, Sangerhausen, 06526, Germany

4. Legally registered address of Authorisation Holder	:	Oberröblinger Bahnhofstr. 1, Sangerhausen, 06526, Germany
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2018-04-24
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: SKmed Joachim Knabe, Medizinischer Fachhandel

, Oberröblinger Bahnhofstr. 1, Sangerhausen, 06526, 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

3.2. Medicinal gases

Any restrictions or clarifying remarks (for all users): The wholesale is carried out in the premises according to the present site plans dated 06.08.2007.
Only skin and hand disinfectants, infusion solutions and medical oxygen in bottles are traded. The delivery of these products is only to doctors and other consumers.

Der Großhandel wird in den Räumen gemäß den vorliegenden Lageplänen vom 06.08.2007 durchgeführt.
Es werden ausschließlich Haut- und Händedesinfektionsmittel, Infusionslösungen sowie medizinischer Sauerstoff in Flaschen gehandelt. Die Abgabe der genannten Produkte erfolgt nur an Ärzte und andere Verbraucher.

*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_2018_006
	Page 1

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