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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) 8432

2. Name of Authorisation Holder

:

MOVIANTO IRELAND

3. Address(es) of Site(s)

:

CEDAR HOUSE, UNIT 2B, MICHELIN ROAD, NEWTOWNABBEY, BT36 4PT, United Kingdom 

SANDYKNOWES BUSINESS PARK, 605 ANTRIM ROAD, NEWTOWNABBEY, BT36 4RY, United Kingdom 




4. Legally registered address of Authorisation Holder

:

SANDYKNOWES BUSINESS PARK, 605 ANTRIM ROAD, NEWTOWNABBEY, BT36 4RY, 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

:

2020-09-28

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: MOVIANTO IRELAND

, CEDAR HOUSE, UNIT 2B, MICHELIN ROAD, NEWTOWNABBEY, BT36 4PT, 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) 

   3.4. Other products: Products authorised under regulation 174




Name and address of the site: MOVIANTO IRELAND

, SANDYKNOWES BUSINESS PARK, 605 ANTRIM ROAD, NEWTOWNABBEY, BT36 4RY, 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 

   2.5. Other activities(s): Sale and Supply of Non-Medicinal Products


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) 

   3.4. Other products: Products authorised under regulation 174





*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) 8432


Page 1





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