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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

:

108947 G

2. Name of Authorisation Holder

:

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

(ORG-100006099 / LOC-100011645)

3. Address(es) of Site(s)

:

Antonie Van Leeuwenhoeklaan 9, Bilthoven, 3721 MA, Netherlands 

Signaalrood 15, Zoetermeer, 2718 SH, Netherlands 

Keizersgracht 5, Eindhoven, 5611 GB, Netherlands 

Lubeckplein 34, Zwolle, 8017 JS, Netherlands 




4. Legally registered address of Authorisation Holder

:

Antonie Van Leeuwenhoeklaan 9, Bilthoven, 3721 MA

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

:

2026-08-18

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: Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

(ORG-100006099 / LOC-100011645)

, Antonie Van Leeuwenhoeklaan 9, Bilthoven, 3721 MA, 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

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 

     3.2.2. Other temperatures: (please specify) -30 ⁰C, -80 ⁰C -30 ⁰C, -80 ⁰C



Name and address of the site: Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

(ORG-100006099 / LOC-100062483)

, Signaalrood 15, Zoetermeer, 2718 SH, Netherlands   



Human medicinal products


1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 




Name and address of the site: Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

(ORG-100006099 / LOC-100017246)

, Keizersgracht 5, Eindhoven, 5611 GB, Netherlands   



Human medicinal products


1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.2. Products requiring low temperature handling 

     3.2.1. Temperatures between 2 to 8 °C 




Name and address of the site: Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

(ORG-100006099 / LOC-100017292)

, Lubeckplein 34, Zwolle, 8017 JS, Netherlands   



Human medicinal products


1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 

   2.3. Supply 


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.













Union Format for a Wholesale Distribution Authorisation

108947 G


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