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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	:	DE_BB_01_WDA_2020/G3 - 5423/ DRK/08/03.08.2020
2. Name of Authorisation Holder	:	DRK-Blutspendedienst Nord-Ost gemeinnuetzige GmbH
3. Address(es) of Site(s)	:	Institut für Transfusionsmedizin Cottbus, Thiemstraße 105, Cottbus, Brandenburg, 03050, Germany Ruppiner Kliniken, Fehrbelliner Strasse 38, Haus J, Neuruppin, Brandenburg, 16816, Germany Klinikum der Stadt Brandenburg, Hochstraße 29, Haus 6, Brandenburg, Brandenburg, 14770, Germany Asklepios Klinikum Uckermark, Auguststraße 23, Schwedt/ Oder, 16303, Germany

4. Legally registered address of Authorisation Holder	:	Blasewitzer Strasse 68-70, Dresden, Sachsen, 01307, 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	:	2020-08-03
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: DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH

, Institut für Transfusionsmedizin Cottbus, Thiemstraße 105, Cottbus, Brandenburg, 03050, 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 03.06.2020.

Der Großhandel wird in den Räumen gemäß dem vorliegenden Grundrissplan vom 03.06.2020 durchgeführt.

Name and address of the site: DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH

, Ruppiner Kliniken, Fehrbelliner Strasse 38, Haus J, Neuruppin, Brandenburg, 16816, 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 performed in the space according to the present floor plan of 28.05.2020 .

Der Großhandel wird in dem Raum gemäß dem vorliegenden Grundrissplan vom 28.05.2020 durchgeführt.

Name and address of the site: DRK-Bluspendedienst Nord-Ost gemeinnützige GmbH

, Klinikum der Stadt Brandenburg, Hochstraße 29, Haus 6, Brandenburg, Brandenburg, 14770, 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 09.06.2020.

Der Großhandel wird in den Räumen gemäß dem vorliegenden Grundrissplan vom 09.06.2020 durchgeführt.

Name and address of the site: DRK-Blutspendedienst Nord-Ost gemeinnützige GmbH

, Asklepios Klinikum Uckermark, Auguststraße 23, Schwedt/ Oder, 16303, 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 28.05.2020.

Der Großhandel wird in den Räumen gemäß dem vorliegenden Grundrissplan vom 28.05.2020 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	DE_BB_01_WDA_2020/G3 - 5423/ DRK/08/03.08.2020
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