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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-12-03

RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W00409/00002
2. Name of Authorisation Holder	:	Clinigen Ireland Limited (ORG-100016472 / LOC-100036961)
3. Address(es) of Site(s)	:	Unit 12, Boeing Road, Airways Industrial Estate, Santry, D17 K684, Ireland

4. Legally registered address of Authorisation Holder	:	Mayfield Business Park, Lismore, P51 HH76, 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	:	2024-09-13
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: Clinigen Ireland Limited

(ORG-100016472 / LOC-100081117)

, Unit 12, Boeing Road, Airways Industrial Estate, Santry, D17 K684, Ireland

Human medicinal products

1. MEDICINAL PRODUCTS

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

1.2. without a Marketing Authorisation in the EEA and intended for EEA market

1.3. without a Marketing Authorisation in the EEA and intended for exportation

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.2. Holding

2.3. Supply

2.4. Export

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 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 Vaccines3.4.11 Exempt medicinal products3.4.12 Biological products

Reason for Withdrawing:

Duplicate

Union Format for a Wholesale Distribution Authorisation	W00409/00002
	Page 1

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