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Information Messages

The WDA has been withdrawn, withdrawn date is: 2026-08-10

RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W00296/00001
2. Name of Authorisation Holder	:	Rowex Limited (ORG-100004376 / LOC-100002735)
3. Address(es) of Site(s)	:	Newtown, Bantry, P75 V009, Ireland

4. Legally registered address of Authorisation Holder	:	Newtown, Bantry, P75 V009
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	:	2019-09-17
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: Rowex Limited

(ORG-100004376 / LOC-100002735)

, Newtown, Bantry, P75 V009, Ireland

Human medicinal products

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

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.3. Cold chain products(requiring low temperature handling)

3.4. Other products: Please see restrictions or clarifying remarks (for all users).

Any restrictions or clarifying remarks (for all users): 3.4.1 Prescription only medicinal products 3.4.2 Medicinal products for general sale 3.4.3 Over the counter medicinal products for sale through pharmacies only 3.4.9 Traditional herbal medicinal products 3.4.12 Biological products The scope of Section 2.2 of this wholesale distribution authorisation is restricted to medicinal products listed in Section 3.4 only, i.e. the company is not currently authorised to hold/store medicinal products listed in Sections 3.1, 3.2 and 3.3.

Reason for Withdrawing:

Superseded

Union Format for a Wholesale Distribution Authorisation	W00296/00001
	Page 1

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