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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

:

3967 G

2. Name of Authorisation Holder

:

Orange Pharma B.V.

(ORG-100024217 / LOC-100056978)

3. Address(es) of Site(s)

:

Danzigweg 16, Deventer, Overijssel, 7418 EN, Netherlands 

Hamburgweg 2, Deventer, Overijssel, 7418 ES, Netherlands 




4. Legally registered address of Authorisation Holder

:

Danzigweg 16, Deventer, 7418 EN

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

:

2026-09-01

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: Orange Pharma B.V.

(ORG-100024217 / LOC-100056978)

, Danzigweg 16, Deventer, Overijssel, 7418 EN, 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

   2.1. Procurement 

   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 




Name and address of the site: Orange Pharma B.V.

(ORG-100024217 / LOC-100102199)

, Hamburgweg 2, Deventer, Overijssel, 7418 ES, 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

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °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

3967 G


Page 1





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