Medicines and Healthcare products Regulatory Agency

WHOLESALE DISTRIBUTION AUTHORISATION

(MEDICINAL PRODUCTS FOR HUMAN USE)

WHOLESALE DISTRIBUTION AUTHORISATION (MEDICINAL PRODUCTS FOR HUMAN USE)
1. Authorisation NumberUK WDA(H) 18716
2. Name of Authorisation HolderETHIGEN 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. Date31/05/2024
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
ANNEX 1
SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION
Name and address of the site:

ETHIGEN LIMITED (BOLTON), UNIT 30 OAKHILL TRADING ESTATE, DEVONSHIRE ROAD, WORSLEY, MANCHESTER, M28 3PT, UNITED KINGDOM

Site Details for 4.6 Homeopathic products
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
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:

ETHIGEN LTD (KELLS. NORTHERN IRELAND), UNIT 2-5, 110 KILGAD ROAD, KELLS, BALLYMENA, BT42 3EE, UNITED KINGDOM

Site Details for 4.6 Homeopathic products
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
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:

ETHIGEN LIMITED (NEWCASTLE), UNIT 2 CHAINBRIDGE INDUSTRIAL ESTATE, TUNDRY WAY, BLAYDON-ON-TYNE, NE21 5SJ, UNITED KINGDOM

Site Details for 4.6 Homeopathic products
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
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:

ETHIGEN LIMITED, ETHIGEN HOUSE, UNITS 10-16 COLVILLES PLACE, KELVIN INDUSTRIAL ESTATE, EAST KILBRIDE, GLASGOW, G75 0SN, UNITED KINGDOM

Site Details for 4.6 Homeopathic products
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)
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:

ETHIGEN LIMITED - BOLTON DEPOT, UNIT 2B, LECTURERS CLOSE, BOLTON, BL3 6DG, UNITED KINGDOM

Site Details for 4.6 Homeopathic products
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
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