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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	:	6712 G
2. Name of Authorisation Holder	:	VitalAire Nederland B.V. (ORG-100002231 / LOC-100007140)
3. Address(es) of Site(s)	:	Archimedeslaan 11, Lelystad, Flevoland, 8218 ME, Netherlands De Fok 8, Drachten, Friesland, 9206 BD, Netherlands Alexander Bellstraat 10, Nijverdal, Overijssel, 7442 DE, Netherlands Energieweg 3, Waalwijk, Noord-Brabant, 5145 NW, Netherlands

4. Legally registered address of Authorisation Holder	:	Archimedeslaan 11, Lelystad, Flevoland, 8218 ME
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	:	2025-09-08
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: VitalAire Nederland B.V.

(ORG-100002231 / LOC-100007140)

, Archimedeslaan 11, Lelystad, Flevoland, 8218 ME, Netherlands

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

Name and address of the site: VitalAire Nederland B.V.

(ORG-100002231 / LOC-100003162)

, De Fok 8, Drachten, Friesland, 9206 BD, Netherlands

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

Name and address of the site: VitalAire Nederland B.V.

(ORG-100002231 / LOC-100007111)

, Alexander Bellstraat 10, Nijverdal, Overijssel, 7442 DE, Netherlands

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

Name and address of the site: VitalAire Nederland B.V.

(ORG-100002231 / LOC-100098214)

, Energieweg 3, Waalwijk, Noord-Brabant, 5145 NW, Netherlands

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

Union Format for a Wholesale Distribution Authorisation	6712 G
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