Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 8778 |
| 2. Name of Authorisation Holder | SIGMA PHARMACEUTICALS PLC |
| 3. Legally registered address of Authorisation Holder | SIGMA PHARMACEUTICALS PLC, FIFTH FLOOR, WATSON HOUSE, 54-60 BAKER STREET, LONDON, W1U 7BU, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
SIGMA PHARMACEUTICALS PLC, UNITS 1 & 3, SIGMA HOUSE 1 & 2, HD HOUSE AND A PLANT, COLONIAL WAY, WATFORD, WD24 4YR, UNITED KINGDOM SIGMA PHARMACEUTICALS PLC, UNIT 4 IMPERIAL PARK, IMPERIAL WAY, WATFORD, WD24 4PP, UNITED KINGDOM SIGMA PHARMACEUTICALS PLC, UNIT 3 IMPERIAL PARK, IMPERIAL WAY, WATFORD, WD24 4PP, UNITED KINGDOM SIGMA PHARMACEUTICALS PLC, UNIT 2, MOLESEY BUSINESS CENTRE, CENTRAL AVENUE, WEST MOLESEY, KT8 2QZ, 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 | 24/08/2023 |
| 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:
SIGMA PHARMACEUTICALS PLC, UNITS 1 & 3, SIGMA HOUSE 1 & 2, HD HOUSE AND A PLANT, COLONIAL WAY, WATFORD, WD24 4YR, 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 |
| 1.4 With a Marketing Authorisation in EEA member state(s) and intended for the GB parallel import 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 |
| 3.1.2 Medicinal products derived from blood |
| 3.1.3 Immunological medicinal products |
| 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, 4.6 Homeopathics
Name and address of the site:
SIGMA PHARMACEUTICALS PLC, UNIT 4 IMPERIAL PARK, IMPERIAL WAY, WATFORD, WD24 4PP, 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 |
| 1.4 With a Marketing Authorisation in EEA member state(s) and intended for the GB parallel import 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 |
| 3.1.2 Medicinal products derived from blood |
| 3.1.3 Immunological medicinal products |
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, 4.6 Homeopathics
Name and address of the site:
SIGMA PHARMACEUTICALS PLC, UNIT 3 IMPERIAL PARK, IMPERIAL WAY, WATFORD, WD24 4PP, 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 |
| 3.3 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, 4.6 Homeopathics
Name and address of the site:
SIGMA PHARMACEUTICALS PLC, UNIT 2, MOLESEY BUSINESS CENTRE, CENTRAL AVENUE, WEST MOLESEY, KT8 2QZ, 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 |
| 2.3 Supply |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.2 Medicinal products derived from blood |
| 3.1.3 Immunological medicinal products |
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, 4.6 Homeopathics