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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-10-21

RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	W00401/00001
2. Name of Authorisation Holder	:	Shire Pharmaceuticals Ireland Limited (ORG-100000607 / LOC-100011567)
3. Address(es) of Site(s)	:	Block 2 And 3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 Y754, Ireland

4. Legally registered address of Authorisation Holder	:	Block 2 And 3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 Y754
5. Scope of authorisation (complete for each site under 4)	:	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 wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2021-12-03
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: Shire Pharmaceuticals Ireland Limited

(ORG-100000607 / LOC-100011567)

, Block 2 And 3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 Y754, Ireland

Human medicinal products

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

2.3. 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 products 3.4.3 Over the counter medicinal products for sale through pharmacies only 3.4.4 Unauthorised medicinal products 3.4.12 Exempt medicinal products 3.4.13 Biological products 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.

*Art 5 of Directive 2001/83/EC or Art 83 of Regulation EC/726/2004

**Without prejudice to further authorisations as may be required according to national legislation

Reason for Withdrawing:

Withdrawn 09/02/2023

Union Format for a Wholesale Distribution Authorisation	W00401/00001
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