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Information Messages

The WDA has been withdrawn, withdrawn date is: 2024-08-28

RTF Template

Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

1. Authorisation Number	:	W12426/00001
2. Name of Authorisation Holder	:	PNR Pharma Services Ltd.
3. Address(es) of Site(s)	:	Skybridge House, Corballis Road North, Dublin Airport, Swords, Co. Dublin, -, K67 P6K2, Ireland

4. Legally registered address of Authorisation Holder	:	Skybridge House, Corballis Road North, Dublin Airport, Swords, Co. Dublin, -, K67 P6K2, Ireland
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2020-11-10
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: PNR Pharma Services Ltd.

, Skybridge House, Corballis Road North, Dublin Airport, Swords, Co. Dublin, -, K67 P6K2, Ireland

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

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

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 3.4.4 Unauthorised medicinal products 3.4.5 Vaccines 3.4.9 Traditional herbal medicinal products 3.4.11 Exempt medicinal products 3.4.12 Biological products 3.4.13 Advance Therapeutic Medicinal products

*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 26/08/24

Union Format for a Wholesale Distribution Authorisation	W12426/00001
	Page 1

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