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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) 21439

2. Name of Authorisation Holder

:

OXFORD UNIVERSITY HOSPITALS NHS TRUST

3. Address(es) of Site(s)

:

HEADLEY WAY, THE JOHN RADCLIFFE, OXFORD RADCLIFFE HOSPITAL, HEADINGTON, OX3 9DU, United Kingdom 

OXFORD ROAD, BANBURY, OX16 9AL, United Kingdom 

OLD ROAD, HEADINGTON, OXFORD, OX3 7LE, United Kingdom 

UNIT 22, UNIPART BUSINESS PARK, GARSINGTON ROAD, COWLEY, OXFORD, OX4 2PG, United Kingdom 




4. Legally registered address of Authorisation Holder

:

HEADLEY WAY, THE JOHN RADCLIFFE, OXFORD RADCLIFFE HOSPITAL, HEADINGTON, OX3 9DU, 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

:

2020-12-04

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: JOHN RADCLIFFE HOSPITAL, PHARMACY DEPT.

, HEADLEY WAY, THE JOHN RADCLIFFE, OXFORD RADCLIFFE HOSPITAL, HEADINGTON, OX3 9DU, 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 

     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):  3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc)
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: HORTON HOSPITAL, PHARMACY DEPT.

, OXFORD ROAD, BANBURY, OX16 9AL, 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 

     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: PHARMACY PURCHASING & DISTRIBUTION UNIT

, OLD ROAD, HEADINGTON, OXFORD, OX3 7LE, 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

     3.1.2. 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):  3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic
agents etc)
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: OXFORD UNIVERSITY HOSPITALS NHS TRUST

, UNIT 22, UNIPART BUSINESS PARK, GARSINGTON ROAD, COWLEY, OXFORD, OX4 2PG, 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

     3.1.2. 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



*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) 21439


Page 1





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