Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
1. Authorisation Number | UK WDA(H) 42956 |
2. Name of Authorisation Holder | THERAKOS (UK) LIMITED |
3. Legally registered address of Authorisation Holder | THERAKOS (UK) LIMITED, 3 LOTUS PARK, THE CAUSEWAY, STAINES-UPON-THAMES, TW18 3AG, UNITED KINGDOM |
4. Address(es) of Site(s) |
THERAKOS (UK) LIMITED, 3 LOTUS PARK, THE CAUSEWAY, STAINES-UPON-THAMES, TW18 3AG, 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 | 12/06/2024 |
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
Name and address of the site:
THERAKOS (UK) LIMITED, 3 LOTUS PARK, THE CAUSEWAY, STAINES-UPON-THAMES, TW18 3AG, 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) |
2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
2.1 Procurement |
2.3 Supply |
3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
3.4 Other ProductsThe activities performed at the site includes the procurement and supply of medicinal product. The product Uvadex (including UK Product Licence No. PL42956/0001) is a terminally sterilized aqueous formulation of methoxsalen. |
Any restrictions or clarifying remarks (for all users)
4 Categories of Products Handled at this Site: 4.1 Prescription Only Medicines