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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-09-22

RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	W11428/00001
2. Name of Authorisation Holder	:	Atelabaz Limited
3. Address(es) of Site(s)	:	4045 Kingswood Road, Citywest Business Park, Dublin 24, -, -, Ireland

4. Legally registered address of Authorisation Holder	:	4045 Kingswood Road, Citywest Business Park, Dublin 24, -, -, Ireland
5. Scope of authorisation	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesale distribution authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-06-09
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: Atelabaz Limited

, 4045 Kingswood Road, Citywest Business Park, Dublin 24, -, -, Ireland

1. MEDICINAL PRODUCTS

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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.1.2. Medicinal products derived from blood

3.1.3. Immunological medicinal products

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 3.4.5 Vaccines 3.4.6 Parallel imported medicinal products authorised by Parallel Product Authorisation (PPA) 3.4.7 Parallel imported medicinal product authorised by Dual Pack Registration (DPR) 3.4.8 Parallel distributed centrally authorised medicinal products 3.4.9 Traditional herbal medicinal products 3.4.10 Homeopathic medicinal products registered under the Simplified Registration Scheme 3.4.11 Homeopathic medicinal products authorised under the National Rules Scheme 3.4.12 Exempt medicinal products 3.4.13 Biological products 3.4.14 Advance Therapeutic Medicinal products

Reason for Withdrawing:

WDA was withdrawn at the request of the company

Union Format for a Wholesale Distribution Authorisation	W11428/00001
	Page 1

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