Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 14172 |
| 2. Name of Authorisation Holder | MOVIANTO UK LIMITED |
| 3. Legally registered address of Authorisation Holder | MOVIANTO UK LIMITED, 1A PROGRESS PARK, ELSTOW, BEDFORD, MK42 9XE, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
MOVIANTO UK LIMITED, 1A PROGRESS PARK, ELSTOW, BEDFORD, MK42 9XE, UNITED KINGDOM MOVIANTO UK LIMITED, UNIT 9 XPRESSWAY BUSINESS PARK, CHUDLEIGH, NEWTON ABBOT, TQ13 0FJ, UNITED KINGDOM MOVIANTO UK LIMITED, UNIT 1, YORK ROAD, CHAPELHALL, AIRDRIE, ML6 8HW, UNITED KINGDOM MOVIANTO UK LIMITED, GIMBALD CRAG CLOSE, ST JAMES BUSINESS PARK, KNARESBOROUGH, HG5 8PJ, UNITED KINGDOM MOVIANTO UK LIMITED, MPS 4, MAGNA PARK SOUTH, LUTTERWORTH, LE17 4XP, UNITED KINGDOM MOVIANTO UK LIMITED, UNIT 2, FINEPOINT, FINEPOINT WAY, KIDDERMINSTER, DY11 7FB, UNITED KINGDOM MOVIANTO UK LIMITED, UNIT 23, HERONS GATE TRADING ESTATE, PAYCOCKE ROAD, BASILDON, SS14 3EU, UNITED KINGDOM MOVIANTO UK LIMITED, BUILDING 1, HAYDOCK GREEN, PENNY LANE, HAYDOCK, ST. HELENS, WA11 9SE, UNITED KINGDOM MOVIANTO UK LIMITED, UNIT 10, ACCESS 18, KINGS WESTON LANE, BRISTOL, BS11 8AZ, UNITED KINGDOM MOVIANTO UK LIMITED, UNIT F2, GRAFTON WAY, BASINGSTOKE, RG22 6HY, UNITED KINGDOM |
| 5. Scope of authorisation (complete for each site under 4) | ANNEX 1 |
| 6. Legal basis of authorisation | Regulation 18 of the Human Medicines Regulations 2012 |
| 7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation | Confidential |
| 8. Date | 03/03/2021 |
| 9. 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 Additional provisions |
ANNEX 1
Name and address of the site:
MOVIANTO UK LIMITED, 1A PROGRESS PARK, ELSTOW, BEDFORD, MK42 9XE, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK 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 |
| 3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| 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, 4.5 Traditional Herbal Medicinal products
Name and address of the site:
MOVIANTO UK LIMITED, UNIT 9 XPRESSWAY BUSINESS PARK, CHUDLEIGH, NEWTON ABBOT, TQ13 0FJ, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.2 Holding |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.2 Medicinal products derived from blood |
| 3.1.3 Immunological medicinal products |
| 3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| 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, 4.5 Traditional Herbal Medicinal products
Name and address of the site:
MOVIANTO UK LIMITED, UNIT 1, YORK ROAD, CHAPELHALL, AIRDRIE, ML6 8HW, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.2 Holding |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.2 Medicinal products derived from blood |
| 3.1.3 Immunological medicinal products |
| 3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| 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, 4.5 Traditional Herbal Medicinal products
Name and address of the site:
MOVIANTO UK LIMITED, GIMBALD CRAG CLOSE, ST JAMES BUSINESS PARK, KNARESBOROUGH, HG5 8PJ, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.1 Procurement |
| 2.2 Holding |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.2 Medicinal products derived from blood |
| 3.1.3 Immunological medicinal products |
| 3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| 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, 4.5 Traditional Herbal Medicinal products
Name and address of the site:
MOVIANTO UK LIMITED, MPS 4, MAGNA PARK SOUTH, LUTTERWORTH, LE17 4XP, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK 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 |
| 3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| 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, 4.5 Traditional Herbal Medicinal products
Name and address of the site:
MOVIANTO UK LIMITED, UNIT 2, FINEPOINT, FINEPOINT WAY, KIDDERMINSTER, DY11 7FB, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.1 Procurement |
| 2.2 Holding |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.2 Medicinal products derived from blood |
| 3.1.3 Immunological medicinal products |
| 3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| 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, 4.5 Traditional Herbal Medicinal products
Name and address of the site:
MOVIANTO UK LIMITED, UNIT 23, HERONS GATE TRADING ESTATE, PAYCOCKE ROAD, BASILDON, SS14 3EU, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.2 Holding |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.2 Medicinal products derived from blood |
| 3.1.3 Immunological medicinal products |
| 3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| 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, 4.5 Traditional Herbal Medicinal products
Name and address of the site:
MOVIANTO UK LIMITED, BUILDING 1, HAYDOCK GREEN, PENNY LANE, HAYDOCK, ST. HELENS, WA11 9SE, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK 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 |
| 3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| 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, 4.5 Traditional Herbal Medicinal products
Name and address of the site:
MOVIANTO UK LIMITED, UNIT 10, ACCESS 18, KINGS WESTON LANE, BRISTOL, BS11 8AZ, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.2 Holding |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.2 Medicinal products derived from blood |
| 3.1.3 Immunological medicinal products |
| 3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| 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, 4.5 Traditional Herbal Medicinal products
Name and address of the site:
MOVIANTO UK LIMITED, UNIT F2, GRAFTON WAY, BASINGSTOKE, RG22 6HY, UNITED KINGDOM
| 1. MEDICINAL PRODUCTS |
| 1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) |
| 1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.2 Holding |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.2 Medicinal products derived from blood |
| 3.1.3 Immunological medicinal products |
| 3.1.5 Products authorised under regulation 174 (supply in response to spread of pathogenic agents etc) |
| 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, 4.5 Traditional Herbal Medicinal products