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RTF Template

Department of Occupational Health and Safety, Customer Protection and Health

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	G3-5423/MVZ_Laborverbund/06/25.02.2019
2. Name of Authorisation Holder	:	MVZ Laborverbund GmbH
3. Address(es) of Site(s)	:	Laborstandort Bernau, Ladeburger Str. 17, Bernau, 16321, Germany Laborstandort Rüdersdorf, Seebad 82/83, Rüdersdorf, 15562, Germany

4. Legally registered address of Authorisation Holder	:	Neuendorfstraße 16 a, Hennigsdorf, 16761, 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	:	2019-02-25
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: MVZ Laborverbund GmbH

, Laborstandort Bernau, Ladeburger Str. 17, Bernau, 16321, 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

3.1.2. Medicinal products derived from blood

Any restrictions or clarifying remarks (for all users): The wholesale is carried out in the premises according to the present floor plan of 04.12.2018 (Immanuel Klinikum Bernau, Krankenhaus Bernau GmbH, EG Laboratory).

Der Großhandel wird in den Räumen gemäß dem vorliegenden Grundrissplan vom 04.12.2018 (Immanuel Klinikum Bernau, Krankenhaus Bernau GmbH, EG Labor) durchgeführt.

Name and address of the site: MVZ Laborverbund GmbH

, Laborstandort Rüdersdorf, Seebad 82/83, Rüdersdorf, 15562, 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

3.1.2. Medicinal products derived from blood

Any restrictions or clarifying remarks (for all users): The wholesale trade is carried out in the premises according to the present floor plan of 04.12.2018 (Immanuel Klinik Rüdersdorf, hospital Rüdersdorf, 1.UG).

Der Großhandel wird in den Räumen gemäß dem vorliegenden Grundrissplan vom 04.12.2018 (Immanuel Klinik Rüdersdorf, Krankenhaus Rüdersdorf, 1.UG) durchgeführt.

*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	G3-5423/MVZ_Laborverbund/06/25.02.2019
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