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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-04-28

RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W00071/00001
2. Name of Authorisation Holder	:	Clonmel Healthcare Limited (ORG-100004076 / LOC-100000601)
3. Address(es) of Site(s)	:	Waterford Road, Gurtnafleur, Clonmel, E91 D768, Ireland

4. Legally registered address of Authorisation Holder	:	Waterford Road, Clonmel, E91 D768, 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	:	2024-05-28
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: Clonmel Healthcare Limited

(ORG-100004076 / LOC-100000601)

, Waterford Road, Gurtnafleur, Clonmel, E91 D768, 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

2.2. Holding

2.3. Supply

2.4. Export

Any restrictions or clarifying remarks (for all users): 3.4.1 Prescription only medicinal products3.4.2 Medicinal products for general sale3.4.3 Over the counter medicinal products for sale through pharmacies only3.4.4 Unauthorised medicinal products3.4.5 Vaccines3.4.9 Traditional herbal medicinal products3.4.11 Exempt medicinal products3.4.12 Biological productsNote all contact storage sites listed in Annex 2 are authorised to store all medicinal product categories specified in section 3 above.In relation to category 3.3 Cold chain products, the company is authorised only for the procurement and supply of this category. The company is not authorised to physically hold 3.3.

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

Reason for Withdrawing:

superseded

Union Format for a Wholesale Distribution Authorisation	W00071/00001
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