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RTF Template


Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

W12429/00001

2. Name of Authorisation Holder

:

Exertis Supply Chain Services Limited

3. Address(es) of Site(s)

:

Sarsfield Road, Raheen Business Park, Co. Limerick, -, -, Ireland 




4. Legally registered address of Authorisation Holder

:

M50 Business Park, Ballymount Road Upper, Dublin 12, -, D12 T4C2, 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

:

2019-02-01

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: Exertis Supply Chain Services Limited

, Sarsfield Road, Raheen Business Park, Co. Limerick, -, -, Ireland   




1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   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 only



*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













Union Format for a Wholesale Distribution Authorisation

W12429/00001


Page 1





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