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RTF Template


Health Products Regulatory Authority

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products


1. Authorisation Number

:

W11254/00001

2. Name of Authorisation Holder

:

Hsd Healthcare Limited

(ORG-100019518 / LOC-100071222)

3. Address(es) of Site(s)

:

Unit 28, Western Parkway Business Centre, Lower Ballymount Road, Dublin 12, D12 NC80, Ireland 




4. Legally registered address of Authorisation Holder

:

Unit 28, Western Parkway Business Centre, Lower Ballymount Road, Dublin 12, D12 NC80

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

:

2022-06-10

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: Hsd Healthcare Limited

(ORG-100019518 / LOC-100071222)

, Unit 28, Western Parkway Business Centre, Lower Ballymount Road, Dublin 12, D12 NC80, Ireland   



Human medicinal products


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 

   2.2. Holding 

   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 3.4.2 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 3.4.6 Parallel imported medicinal products authorised by Parallel Product Authorisation (PPA) 3.4.7 Parallel imported medicinal product authorised by Dual Pack Registration (DPR) 3.4.8 Parallel distributed centrally authorised medicinal products 3.4.11 Exempt medicinal products 3.4.12 Biological 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













Union Format for a Wholesale Distribution Authorisation

W11254/00001


Page 1





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