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Information Messages

The WDA has been withdrawn, withdrawn date is: 2025-12-10

RTF Template

An tÚdarás Rialála Táirgí Sláinte

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	W11482/00001
2. Name of Authorisation Holder	:	Grifols Worldwide Operations Limited
3. Address(es) of Site(s)	:	Grange Castle Business Park, Grange Castle, Clondalkin, Dublin 22, -, -, Ireland

4. Legally registered address of Authorisation Holder	:	Grange Castle Business Park, Grange Castle, Clondalkin, Dublin 22, -, -, 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	:	2020-07-03
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: Grifols Worldwide Operations Limited

, Grange Castle Business Park, Grange Castle, Clondalkin, Dublin 22, -, -, Ireland

1. MEDICINAL PRODUCTS

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

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

3.3. 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 3.4.4 Unauthorised medicinal products 3.4.12 Biological products Restrictions: Not all of the contract wholesale distribution sites listed in Annex 2 are appropriately authorised to hold all of the medicinal product categories listed in Annex 1.

Reason for Withdrawing:

Superseded

Union Format for a Wholesale Distribution Authorisation	W11482/00001
	Page 1

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