Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 18716 |
| 2. Name of Authorisation Holder | ETHIGEN LIMITED |
| 3. Legally registered address of Authorisation Holder | ETHIGEN LIMITED, ETHIGEN HOUSE, UNITS 10-16 COLVILLES PLACE, KELVIN INDUSTRIAL ESTATE, EAST KILBRIDE, GLASGOW, G75 0SN, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
ETHIGEN LIMITED (BOLTON), UNIT 30 OAKHILL TRADING ESTATE, DEVONSHIRE ROAD, WORSLEY, MANCHESTER, M28 3PT, UNITED KINGDOM ETHIGEN LTD (KELLS. NORTHERN IRELAND), UNIT 2-5, 110 KILGAD ROAD, KELLS, BALLYMENA, BT42 3EE, UNITED KINGDOM ETHIGEN LIMITED (NEWCASTLE), UNIT 2 CHAINBRIDGE INDUSTRIAL ESTATE, TUNDRY WAY, BLAYDON-ON-TYNE, NE21 5SJ, UNITED KINGDOM ETHIGEN LIMITED, ETHIGEN HOUSE, UNITS 10-16 COLVILLES PLACE, KELVIN INDUSTRIAL ESTATE, EAST KILBRIDE, GLASGOW, G75 0SN, UNITED KINGDOM ETHIGEN LIMITED - BOLTON DEPOT, UNIT 2B, LECTURERS CLOSE, BOLTON, BL3 6DG, 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 | 31/05/2024 |
| 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 |
ETHIGEN LIMITED (BOLTON), UNIT 30 OAKHILL TRADING ESTATE, DEVONSHIRE ROAD, WORSLEY, MANCHESTER, M28 3PT, 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 |
ETHIGEN LTD (KELLS. NORTHERN IRELAND), UNIT 2-5, 110 KILGAD ROAD, KELLS, BALLYMENA, BT42 3EE, 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 |
ETHIGEN LIMITED (NEWCASTLE), UNIT 2 CHAINBRIDGE INDUSTRIAL ESTATE, TUNDRY WAY, BLAYDON-ON-TYNE, NE21 5SJ, 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 |
ETHIGEN LIMITED, ETHIGEN HOUSE, UNITS 10-16 COLVILLES PLACE, KELVIN INDUSTRIAL ESTATE, EAST KILBRIDE, GLASGOW, G75 0SN, 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 |
| 1.4 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 |
| 2.6b Products not 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) |
ETHIGEN LIMITED - BOLTON DEPOT, UNIT 2B, LECTURERS CLOSE, BOLTON, BL3 6DG, 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 |