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RTF Template


Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

W12518/00001

2. Name of Authorisation Holder

:

Alimera Sciences Europe Limited

(ORG-100013906 / LOC-100019689)

3. Address(es) of Site(s)

:

Block C, 77 Sir John Rogerson's Quay, Dublin 2, D02 VK60, Ireland 




4. Legally registered address of Authorisation Holder

:

Block C, 77 Sir John Rogerson's Quay, Dublin 2, D02 VK60

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

:

2026-05-19

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: Alimera Sciences Europe Limited

(ORG-100013906 / LOC-100019689)

, Block C, 77 Sir John Rogerson's Quay, Dublin 2, D02 VK60, Ireland   



Human medicinal products


1. MEDICINAL PRODUCTS

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


2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.3. Supply 

   2.4. Export 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

   3.3. Other products: (please specify here or make a reference to Annex 5) N/A




Any restrictions or clarifying remarks (for all users):  The contract wholesale distribution site of Arvato SE includes additionally the house number Gottlieb-Daimler-Strasse 2 per the clarifying remarks on the site's WDA,3.3.01 Prescription only medicinal products















Union Format for a Wholesale Distribution Authorisation

W12518/00001


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