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) 4321
2. Name of Authorisation HolderDURBIN PLC
3. Legally registered address of Authorisation Holder DURBIN PLC, UNIT 5, SWALLOWFIELD WAY, HAYES, UB3 1DQ, UNITED KINGDOM
4. Address(es) of Site(s)

DURBIN PLC, LAMBOURN HOUSE, REDLANDS, COULSDON, CR5 2HT, UNITED KINGDOM

DURBIN PLC, UNIT 5, SWALLOWFIELD WAY, HAYES, UB3 1DQ, 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. Date01/07/2024
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:

DURBIN PLC, LAMBOURN HOUSE, REDLANDS, COULSDON, CR5 2HT, 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
  2.1 Procurement
  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
  3.2 Medicinal gases
  3.3 Cold chain products (requiring low temperature handling)
  3.4 Other Products
advanced therapy 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:

DURBIN PLC, UNIT 5, SWALLOWFIELD WAY, HAYES, UB3 1DQ, 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
  2.1 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
  3.2 Medicinal gases
  3.3 Cold chain products (requiring low temperature handling)
  3.4 Other Products
advanced therapy 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