Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 4 |
| 2. Name of Authorisation Holder | GLAXO OPERATIONS UK LIMITED |
| 3. Legally registered address of Authorisation Holder | GLAXO OPERATIONS UK LIMITED, 980 GREAT WEST ROAD, BRENTFORD, TW8 9GS, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, UNITED KINGDOM GLAXO OPERATIONS UK LTD (WARE) T\A GLAXO WELLCOME OPERATIONS, PRIORY STREET, WARE, SG12 0DJ, UNITED KINGDOM GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, 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 | 16/04/2024 |
| 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 |
ANNEX 1
Name and address of the site:
GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, 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 |
| 1.3 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 the UK and not intended for the UK market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.2 Holding |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.3 Immunological medicinal products |
| 3.3 Cold chain products (requiring low temperature handling) |
| 3.4 Other Productsrefer to the GMP and IMP products listed on Manufacturer |
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
Name and address of the site:
GLAXO OPERATIONS UK LTD (WARE) T\A GLAXO WELLCOME OPERATIONS, PRIORY STREET, WARE, SG12 0DJ, 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 |
| 1.3 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 the UK and not intended for the UK market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.2 Holding |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.4 Other Productsrefer to the GMP and IMP products listed on Manufacturer |
Any restrictions or clarifying remarks (for all users)
4 Categories of Products Handled at this Site: 4.1 Prescription Only Medicines
Name and address of the site:
GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS, HARMIRE ROAD, BARNARD CASTLE, DL12 8DT, 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) |
| 1.3 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 the UK and not intended for the UK market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.2 Holding |
Any restrictions or clarifying remarks (for all users)
4 Categories of Products Handled at this Site: 4.1 Prescription Only Medicines