Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 50837 |
| 2. Name of Authorisation Holder | HENRY SCHEIN UK HOLDINGS LIMITED |
| 3. Legally registered address of Authorisation Holder | HENRY SCHEIN UK HOLDINGS LIMITED, MEDCARE NORTH, CENTURION CLOSE, GILLINGHAM BUSINESS PARK, GILLINGHAM, ME8 0SB, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
HENRY SCHEIN DENTAL, INNOVATION FACTORY, 385 SPRINGFIELD ROAD, FORTHRIVER BUSINESS PARK, BELFAST, BT12 7DG, UNITED KINGDOM HENRY SCHEIN UK HOLDINGS LIMITED , MEDCARE NORTH, CENTURION CLOSE, GILLINGHAM BUSINESS PARK, GILLINGHAM, ME8 0SB, UNITED KINGDOM HENRY SCHEIN UK HOLDINGS LTD, SUITE A AND B GROUND FLOOR, ATLANTIC HOUSE WEST, TYNDALL STREET, CARDIFF, CF10 4AZ, UNITED KINGDOM HENRY SCHEIN UK HOLDINGS LIMITED, MEDCARE SOUTH, BAILEY DRIVE, GILLINGHAM BUSINESS PARK, GILLINGHAM, ME8 0PZ, UNITED KINGDOM HENRY SCHEIN UK HOLDINGS LIMITED , GROUND FLOOR, WESTPOINT BUSINESS PARK, 4 MARCHFIELD DRIVE, PAISLEY, PA3 2RB, 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 | 22/11/2024 |
| 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 |
HENRY SCHEIN DENTAL, INNOVATION FACTORY, 385 SPRINGFIELD ROAD, FORTHRIVER BUSINESS PARK, BELFAST, BT12 7DG, 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 |
| 2.3 Supply |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.1 Narcotic or psychotropic products |
| 3.1.3 Immunological medicinal products |
| 3.3 Cold chain products (requiring low temperature handling) |
HENRY SCHEIN UK HOLDINGS LIMITED , MEDCARE NORTH, CENTURION CLOSE, GILLINGHAM BUSINESS PARK, GILLINGHAM, ME8 0SB, 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 |
| 2.3 Supply |
| 2.4 Export |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.1 Narcotic or psychotropic products |
| 3.1.3 Immunological medicinal products |
| 3.3 Cold chain products (requiring low temperature handling) |
HENRY SCHEIN UK HOLDINGS LTD, SUITE A AND B GROUND FLOOR, ATLANTIC HOUSE WEST, TYNDALL STREET, CARDIFF, CF10 4AZ, 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 |
| 2.3 Supply |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.3 Immunological medicinal products |
| 3.3 Cold chain products (requiring low temperature handling) |
HENRY SCHEIN UK HOLDINGS LIMITED, MEDCARE SOUTH, BAILEY DRIVE, GILLINGHAM BUSINESS PARK, GILLINGHAM, ME8 0PZ, 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 |
| 2.3 Supply |
| 2.4 Export |
| 2.6 Products imported from countries on a list |
| 2.6a Products certified under Article 51 of Directive 2001/83/EC |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.1 Narcotic or psychotropic products |
| 3.1.3 Immunological medicinal products |
| 3.3 Cold chain products (requiring low temperature handling) |
HENRY SCHEIN UK HOLDINGS LIMITED , GROUND FLOOR, WESTPOINT BUSINESS PARK, 4 MARCHFIELD DRIVE, PAISLEY, PA3 2RB, 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 |
| 2.3 Supply |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.1 Narcotic or psychotropic products |
| 3.1.3 Immunological medicinal products |
| 3.3 Cold chain products (requiring low temperature handling) |