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RTF Template

Federal Agency For Medicines And Health Products

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	1768 H
2. Name of Authorisation Holder	:	Yusen Logistics (Benelux) B.V. (ORG-100022600 / LOC-100031279)
3. Address(es) of Site(s)	:	Haven 1089, Keetberglaan 1, Beveren, 9120, Belgium Isnes, Rue Camille Hubert 24, Gembloux, 5032, Belgium Haven 1089, Keetberglaan 2, Beveren, 9120, Belgium

4. Legally registered address of Authorisation Holder	:	Haven 1089, Keetberglaan 2, Beveren, 9120, Belgium
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2024-09-26
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: Yusen Logistics (Benelux) B.V.

(ORG-100022600 / LOC-100076988)

, Haven 1089, Keetberglaan 1, Beveren, 9120, Belgium

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: retention samples - intermediates referentiestalen - half-afgewerkte producten

Any restrictions or clarifying remarks (for all users): 1.3 Warehouse under the authority of the customs.
3.3 Authorized temperature for the cold chain : 2-8°C

1.3 Opslagplaats onder de bevoegdheid van de douanes.
3.3 Toegestane temperatuur voor de koude bewaring : 2-8°C

Name and address of the site: Yusen Logistics (Benelux) B.V.

(ORG-100022600 / LOC-100091601)

, Isnes, Rue Camille Hubert 24, Gembloux, 5032, Belgium

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.3. Immunological medicinal products

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Storage of production intermediates Opslag van productie tussenproducten

Any restrictions or clarifying remarks (for all users): 3.3 Authorized temperature for the cold chain : 2-8 °C / -25° C

3.3 Toegestane temperatuur voor de koude bewaring : 2-8 °C / -25° C

Name and address of the site: Yusen Logistics (Benelux) B.V.

(ORG-100022600 / LOC-100031279)

, Haven 1089, Keetberglaan 2, Beveren, 9120, Belgium

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation in EEA country(s)

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.2. Holding

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

3.4. Other products: retention samples - intermediates referentiestalen - half-afgewerkte producten

Any restrictions or clarifying remarks (for all users): 1.3 Warehouse under the authority of the customs.

1.3 Opslagplaats onder de bevoegdheid van de douanes.

*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	1768 H
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