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RTF Template

Ministerie van Volksgezondheid, Welzijn en Sport - Farmatec | CIBG - Cluster Beschikkingen

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	5390 G
2. Name of Authorisation Holder	:	Vivisol Nederland B.V., TILBURG
3. Address(es) of Site(s)	:	Jellinghausstraat 45, TILBURG, 5048AZ, Netherlands Tweede Bloksweg 54, WADDINXVEEN, 2742KK, Netherlands James Cookstraat 3, EMMEN, 7825AN, Netherlands

4. Legally registered address of Authorisation Holder	:	Swaardvenstraat 27, TILBURG, 5048AV, Netherlands
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-04-17
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: Vivisol Nederland B.V.

, Jellinghausstraat 45, TILBURG, 5048AZ, Netherlands

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

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

, Tweede Bloksweg 54, WADDINXVEEN, 2742KK, Netherlands

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

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

, James Cookstraat 3, EMMEN, 7825AN, Netherlands

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Medicinal gases

*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	5390 G
	Page 1

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