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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-04-29

RTF Template

Hessian Office For Health And Care

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	DE_HE_01_WDA_2023_0059 / V5 18 L 18.01 - 1249-B
2. Name of Authorisation Holder	:	HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH (ORG-100036564 / LOC-100057804)
3. Address(es) of Site(s)	:	Ludwig-Erhard-Strasse 100, Dotzheim, Wiesbaden, 65199, Germany Aukammallee 33, Bierstadt, Wiesbaden, Hassia, 65191, Germany Robert-Koch-Strasse 2, Idstein, Hassia, 65510, Germany

4. Legally registered address of Authorisation Holder	:	Ludwig-Erhard-Strasse 100, Dotzheim, Wiesbaden, 65199
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:	Sect 52a para 1 German Medicinal Product Act
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-01-03
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: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH

(ORG-100036564 / LOC-100057804)

, Ludwig-Erhard-Strasse 100, Dotzheim, Wiesbaden, 65199, Germany

Human medicinal products

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Location:
Level 01, Room 01-L-37, 01-L-38, 01-L-39
Room HISO1060 (Ward C1) Blood storage refrigerator: Sub-depot
OP area (transition from septic to aseptic OP)
Blood storage refrigerator

Ref. to 3.1.2 and 3.3: medicinal products derived from blood in accordance with Directive 2002/98 EC
• Erythrocyte concentrate inline-filtered
• Erythrocyte concentrate irradiated inline-filtered
• Erythrocyte concentrate inline-filtered divided
• Erythrocyte concentrate inline-filtered divided irradiated
• Platelets concentrate apheresis
• Platelets concentrate pooled
• Platelets concentrate apheresis irradiated
• Fresh frozen plasma
• Lyophilized human plasma
• Erythrocyte concentrate autologous
• Fresh frozen plasma autologous
• Granulocytes concentrate

Standort:
Ebene 01, Raum 01-L-37, 01-L-38, 01-L-39
Raum HISO1060 (Station C1) Blutkonservenkühlschrank: Subdepot
OP-Bereich (Übergang vom septischen zum aspetischen OP)
Blutkonservenkühlschrank

Zu 3.1.2 und 3.3: Arzneimittel aus Blut gemäß der Richtlinie 2002/98 EG
• Erythrozytenkonzentrat inline-filtriert
• Erythrozytenkonzentrat inline-filtriert bestrahlt
• Erythrozytenkonzentrat inline-filtriert geteilt
• Erythrozytenkonzentrat inline-filtriert geteilt bestrahlt
• Thrombozytenkonzentrat Apherese
• Thrombozytenkonzentrat gepoolt
• Thrombozytenkonzentrat Apherese bestrahlt
• Gefrierplasma
• Lyophilisiertes Humanplasma
• Erythrozytenkonzentrat autolog
• Gefrierplasma autolog
• Granulozytenkonzentrat

Name and address of the site: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH

(ORG-100036564 / LOC-100065251)

, Aukammallee 33, Bierstadt, Wiesbaden, Hassia, 65191, Germany

Human medicinal products

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Location:
DKD Wiesbaden
Building A, 4th floor room A.428c (POCT laboratory)

Ref. to 3.1.2 and 3.3: medicinal products derived from blood in accordance with Directive 2002/98 EC
• Erythrocyte concentrate inline-filtered
• Erythrocyte concentrate irradiated inline-filtered
• Erythrocyte concentrate inline-filtered divided
• Erythrocyte concentrate inline-filtered divided irradiated
• Platelets concentrate apheresis
• Platelets concentrate pooled
• Platelets concentrate apheresis irradiated
• Fresh frozen plasma
• Lyophilized human plasma
• Erythrocyte concentrate autologous
• Fresh frozen plasma autologous
• Granulocytes concentrate

Standort:
DKD Wiesbaden
Gebäude A, 4. OG Raum A.428c (POCT-Labor)

Zu 3.1.2 und 3.3: Arzneimittel aus Blut gemäß der Richtlinie 2002/98 EG
• Erythrozytenkonzentrat inline-filtriert
• Erythrozytenkonzentrat inline-filtriert bestrahlt
• Erythrozytenkonzentrat inline-filtriert geteilt
• Erythrozytenkonzentrat inline-filtriert geteilt bestrahlt
• Thrombozytenkonzentrat Apherese
• Thrombozytenkonzentrat gepoolt
• Thrombozytenkonzentrat Apherese bestrahlt
• Gefrierplasma
• Lyophilisiertes Humanplasma
• Erythrozytenkonzentrat autolog
• Gefrierplasma autolog
• Granulozytenkonzentrat

Name and address of the site: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden GmbH

(ORG-100036564 / LOC-100065250)

, Robert-Koch-Strasse 2, Idstein, Hassia, 65510, Germany

Human medicinal products

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

3.3. Cold chain products(requiring low temperature handling)

Any restrictions or clarifying remarks (for all users): Location:
Helios Clinic Idstein
Blood storage refrigerator ID-207/1, room E 004.2 (laboratory)

Ref. to 3.1.2 and 3.3: medicinal products derived from blood in accordance with Directive 2002/98 EC
• Erythrocyte concentrate inline-filtered
• Erythrocyte concentrate irradiated inline-filtered
• Erythrocyte concentrate inline-filtered divided
• Erythrocyte concentrate inline-filtered divided irradiated
• Platelets concentrate apheresis
• Platelets concentrate pooled
• Platelets concentrate apheresis irradiated
• Fresh frozen plasma
• Lyophilized human plasma
• Erythrocyte concentrate autologous
• Fresh frozen plasma autologous
• Granulocytes concentrate

Standort:
Helios Klinik Idstein
Blutkonservenkühlschrank ID-207/1, Raum E 004.2 (Labor)

Zu 3.1.2 und 3.3: Arzneimittel aus Blut gemäß der Richtlinie 2002/98 EG
• Erythrozytenkonzentrat inline-filtriert
• Erythrozytenkonzentrat inline-filtriert bestrahlt
• Erythrozytenkonzentrat inline-filtriert geteilt
• Erythrozytenkonzentrat inline-filtriert geteilt bestrahlt
• Thrombozytenkonzentrat Apherese
• Thrombozytenkonzentrat gepoolt
• Thrombozytenkonzentrat Apherese bestrahlt
• Gefrierplasma
• Lyophilisiertes Humanplasma
• Erythrozytenkonzentrat autolog
• Gefrierplasma autolog
• Granulozytenkonzentrat

Reason for Withdrawing:

Replaced by DE_HE_01_WDA_2026_0003 / V5 18 L 18.01 - 1249-B

Ersetzt durch DE_HE_01_WDA_2026_0003 / V5 18 L 18.01 - 1249-B

Union Format for a Wholesale Distribution Authorisation	DE_HE_01_WDA_2023_0059 / V5 18 L 18.01 - 1249-B
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