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RTF Template


Medicines and Healthcare Products Regulatory Agency

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION


1. Authorisation Number

:

UK WDA(H) 35929

2. Name of Authorisation Holder

:

CARDIFF AND VALE UNIVERSITY LOCAL HEALTH BOARD

3. Address(es) of Site(s)

:

UNIT 1, PARC TY GLAS, LLANISHEN, CARDIFF, CF14 5DU, United Kingdom 

BUILDING 873, PICKETSON SITE, AEROSPACE BUSINESS PARK ST ATHAN, EGLWYS BREWIS ROAD, PICKETSON, BARRY, CF62 4QR, United Kingdom 

ST MARY'S PHARMACEUTICAL UNIT, 20 FIELD WAY, CARDIFF, CF14 4HY, United Kingdom 




4. Legally registered address of Authorisation Holder

:

UNIVERSITY HOSPITAL OF WALES, HEATH PARK, CARDIFF, CF14 4XW, United Kingdom

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

:

2020-12-23

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: CARDIFF AND VALE UNIVERSITY LOCAL HEALTH BOARD

, UNIT 1, PARC TY GLAS, LLANISHEN, CARDIFF, CF14 5DU, United Kingdom   




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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 

   2.3. Supply 


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) 




Any restrictions or clarifying remarks (for all users):  4. CATEGORIES OF PRODUCTS HANDLED AT THIS SITE
4.1 Prescription Only Medicines
4.2 General Sales List
4.4 Pharmacy


Name and address of the site: CARDIFF AND VALE UNIVERSITY LOCAL HEALTH BOARD

, BUILDING 873, PICKETSON SITE, AEROSPACE BUSINESS PARK ST ATHAN, EGLWYS BREWIS ROAD, PICKETSON, BARRY, CF62 4QR, United Kingdom   




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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.2. Holding 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 




Any restrictions or clarifying remarks (for all users):  4. CATEGORIES OF PRODUCTS HANDLED AT THIS SITE
4.1 Prescription Only Medicines


Name and address of the site: CARDIFF AND VALE UNIVERSITY LOCAL HEALTH BOARD

, ST MARY'S PHARMACEUTICAL UNIT, 20 FIELD WAY, CARDIFF, CF14 4HY, United Kingdom   




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

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

   2.1. Procurement 

   2.2. Holding 

   2.3. Supply 


3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

     3.1.1. Narcotic or psychotropic products 

     3.1.2. Medicinal products derived from blood 

     3.1.3. Immunological medicinal products 

   3.3. Cold chain products(requiring low temperature handling) 




Any restrictions or clarifying remarks (for all users):  4 Categories of Products Handled at this Site: 4.1 Prescription Only Medicines, 4.2 General Sales List, 4.4 Pharmacy

3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc)



*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

UK WDA(H) 35929


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