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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	:	109203 G
2. Name of Authorisation Holder	:	Galderma S.A. the Netherlands Branch (ORG-100043149 / LOC-100103619)
3. Address(es) of Site(s)	:	Gravinnen Van Nassauboulevard 91, Breda, Noord-Brabant, 4811 BN, Netherlands De Ruijterkade 6, Amsterdam, Noord-Holland, 1013 AA, Netherlands

4. Legally registered address of Authorisation Holder	:	De Ruijterkade 6, Amsterdam, Noord-Holland, 1013 AA
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: Galderma S.A. the Netherlands Branch

(ORG-100043149 / LOC-100071392)

, Gravinnen Van Nassauboulevard 91, Breda, Noord-Brabant, 4811 BN, Netherlands

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

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

Name and address of the site: Galderma S.A. the Netherlands Branch

(ORG-100043149 / LOC-100103619)

, De Ruijterkade 6, Amsterdam, Noord-Holland, 1013 AA, Netherlands

Human medicinal products

1. MEDICINAL PRODUCTS

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

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

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

Union Format for a Wholesale Distribution Authorisation	109203 G
	Page 1

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