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RTF Template


Ministerie van Volksgezondheid Welzijn en Sport

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

108945 G

2. Name of Authorisation Holder

:

DHL Supply Chain (Netherlands) B.V.

(ORG-100011661 / LOC-100056486)

3. Address(es) of Site(s)

:

Bijsterhuizen 1127, Nijmegen, 6546 AR, Netherlands 

Bijsterhuizen 3142, Wijchen, 6604 LV, Netherlands 




4. Legally registered address of Authorisation Holder

:

Anderlechtstraat 15, Eindhoven, 5628 WB

5. Scope of authorisation

:

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 wholesale distribution authorisation

:

Confidential, Confidential

8. Signature

:


9. Date

:

2025-08-04

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: DHL Supply Chain (Netherlands) B.V.

(ORG-100011661 / LOC-100021797)

, Bijsterhuizen 1127, Nijmegen, 6546 AR, Netherlands   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.1. Narcotic or psychotropic products** 

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 

     3.2.2. Other temperatures: (please specify) between -20 to -80 °C tussen -20 en -80 °C




Name and address of the site: DHL Supply Chain (Netherlands) B.V.

(ORG-100011661 / LOC-100035126)

, Bijsterhuizen 3142, Wijchen, 6604 LV, Netherlands   



Human medicinal products


1. MEDICINAL PRODUCTS

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

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

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.1. Narcotic or psychotropic products** 

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 

     3.2.2. Other temperatures: (please specify) between -20 to -80 °C tussen -20 en -80 °C





*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

**Without prejudice to further authorisations as may be required according to national legislation.













Union Format for a Wholesale Distribution Authorisation

108945 G


Page 1





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