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
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
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site: MOVIANTO IRELAND
, CEDAR HOUSE, UNIT 2B, MICHELIN ROAD, NEWTOWNABBEY, BT36 4PT, United Kingdom
1.1. with a Marketing Authorisation in EEA country(s)
1.2. without a Marketing Authorisation in the EEA and intended for EEA market
2.2. Holding
2.3. Supply
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
, SANDYKNOWES BUSINESS PARK, 605 ANTRIM ROAD, NEWTOWNABBEY, BT36 4RY, United Kingdom
2.1. Procurement
2.5. Other activities(s): Sale and Supply of Non-Medicinal Products
3.1.1. Narcotic or psychotropic 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
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