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) 51808
2. Name of Authorisation HolderCELLTRION HEALTHCARE UNITED KINGDOM LIMITED
3. Legally registered address of Authorisation Holder CELLTRION HEALTHCARE UNITED KINGDOM LIMITED, THE SWITCH, 1-7 THE GROVE, SLOUGH, SL1 1QP, UNITED KINGDOM
4. Address(es) of Site(s)

CELLTRION HEALTHCARE UNITED KINGDOM LIMITED, THE SWITCH, 1-7 THE GROVE, SLOUGH, SL1 1QP, 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. Date11/12/2023
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:

CELLTRION HEALTHCARE UNITED KINGDOM LIMITED, THE SWITCH, 1-7 THE GROVE, SLOUGH, SL1 1QP, 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)
2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS
  2.1 Procurement
  2.3 Supply
  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
    3.1.3 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