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) 15184
2. Name of Authorisation HolderLEXON (UK) LIMITED
3. Legally registered address of Authorisation Holder LEXON (UK) LIMITED, UNIT 18 OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, B98 0RE, UNITED KINGDOM
4. Address(es) of Site(s)

LEXON (UK) LIMITED, NORCHEM HOUSE, CHILTON INDUSTRIAL ESTATE, CHILTON, FERRYHILL, DL17 0PD, UNITED KINGDOM

LEXON (UK) LIMITED, UNIT 3, PHILIPPA WAY, LEEDS, LS12 6LS, UNITED KINGDOM

LEXON (UK) LIMITED, 3A YOUNG PLACE, KELVIN INDUSTRIAL ESTATE, EAST KILBRIDE, GLASGOW, G75 0TD, UNITED KINGDOM

LEXON (UK) LIMITED, UNIT 11, PALMERS ROAD, EAST MOONS MOAT, REDDITCH, B98 0RF, UNITED KINGDOM

LEXON (UK) LIMITED, UNIT 18 OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, B98 0RE, UNITED KINGDOM

LEXON (UK) LIMITED, UNIT 17 OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, B98 0RE, UNITED KINGDOM

LEXON (UK) LIMITED, UNIT 10, PALMERS ROAD, EAST MOONS MOAT, REDDITCH, B98 0RF, 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. Date23/10/2024
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:

LEXON (UK) LIMITED, NORCHEM HOUSE, CHILTON INDUSTRIAL ESTATE, CHILTON, FERRYHILL, DL17 0PD, 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
  2.1 Procurement
  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
Name and address of the site:

LEXON (UK) LIMITED, UNIT 3, PHILIPPA WAY, LEEDS, LS12 6LS, 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
  1.3 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
  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
Name and address of the site:

LEXON (UK) LIMITED, 3A YOUNG PLACE, KELVIN INDUSTRIAL ESTATE, EAST KILBRIDE, GLASGOW, G75 0TD, 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
  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
Name and address of the site:

LEXON (UK) LIMITED, UNIT 11, PALMERS ROAD, EAST MOONS MOAT, REDDITCH, B98 0RF, 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
  1.3 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
  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
Name and address of the site:

LEXON (UK) LIMITED, UNIT 18 OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, B98 0RE, 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
  1.3 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
  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
Name and address of the site:

LEXON (UK) LIMITED, UNIT 17 OXLEASOW ROAD, EAST MOONS MOAT, REDDITCH, B98 0RE, 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
  1.3 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
  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
  3.3 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
Name and address of the site:

LEXON (UK) LIMITED, UNIT 10, PALMERS ROAD, EAST MOONS MOAT, REDDITCH, B98 0RF, 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
  2.1 Procurement
  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