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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-06-12

RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W12842/00001
2. Name of Authorisation Holder	:	Aimmune Therapeutics Ireland Limited (ORG-100026553 / LOC-100042452)
3. Address(es) of Site(s)	:	Block B, The Crescent Building, Northwood Crescent, Dublin 9, D09 C6X8, Ireland

4. Legally registered address of Authorisation Holder	:	Block B, The Crescent Building, Northwood Crescent, Dublin 9, D09 C6X8, Ireland
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	:	2023-09-15
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: Aimmune Therapeutics Ireland Limited

(ORG-100026553 / LOC-100042452)

, Block B, The Crescent Building, Northwood Crescent, Dublin 9, D09 C6X8, Ireland

Human medicinal products

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.4. Export

Reason for Withdrawing:

Withdrawal approved

Union Format for a Wholesale Distribution Authorisation	W12842/00001
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