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 DEPOT, UNIT 2B, LECTURERS CLOSE, BOLTON, BL3 6DG, UNITED KINGDOM ETHIGEN LIMITED, ETHIGEN HOUSE, UNITS 10-16 COLVILLES PLACE, KELVIN INDUSTRIAL ESTATE, EAST KILBRIDE, GLASGOW, G75 0SN, UNITED KINGDOM ETHIGEN LTD (NEWCASTLE), UNIT 381E, JEDBURGH COURT, TEAM VALLEY TRADING ESTATE, GATESHEAD, NE11 0BQ, UNITED KINGDOM ETHIGEN LTD (KELLS. NORTHERN IRELAND), UNIT 2-5, 110 KILGAD ROAD, KELLS, BALLYMENA, BT42 3EE, 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 | 12/01/2024 |
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 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 |
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 LTD (NEWCASTLE), UNIT 381E, JEDBURGH COURT, TEAM VALLEY TRADING ESTATE, GATESHEAD, NE11 0BQ, 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 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 |