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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-08-07

RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W12371/00001
2. Name of Authorisation Holder	:	Amryt Pharmaceuticals Designated Activity Company (ORG-100013215 / LOC-100047843)
3. Address(es) of Site(s)	:	45 Mespil Road, Ballsbridge, Dublin 4, D04 W2F1, Ireland

4. Legally registered address of Authorisation Holder	:	45 Mespil Road, Ballsbridge, Dublin 4, D04 W2F1
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	:	2025-03-06
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: Amryt Pharmaceuticals Designated Activity Company

(ORG-100013215 / LOC-100047843)

, 45 Mespil Road, Ballsbridge, Dublin 4, D04 W2F1, Ireland

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

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.3. Other products: (please specify here or make a reference to Annex 5) Please see restrictions or clarifying remarks (for all users).

Any restrictions or clarifying remarks (for all users): 3.3.1 Prescription only medicinal products3.3.4 Unauthorised medicinal products3.3.11 Exempt medicinal products3.3.12 Biological products

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Reason for Withdrawing:

Withdrawal approval date: 06/08/2025

Union Format for a Wholesale Distribution Authorisation	W12371/00001
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