Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 57618 |
| 2. Name of Authorisation Holder | BIOFRONTERA UK LIMITED |
| 3. Legally registered address of Authorisation Holder | BIOFRONTERA UK LIMITED, REGUS, ROTTERDAM HOUSE, 116 QUAYSIDE, NEWCASTLE UPON TYNE, NE1 3DY, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
BIOFRONTERA UK LIMITED, REGUS, ROTTERDAM HOUSE, 116 QUAYSIDE, NEWCASTLE UPON TYNE, NE1 3DY, 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 | 15/08/2025 |
| 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:
BIOFRONTERA UK LIMITED, REGUS, ROTTERDAM HOUSE, 116 QUAYSIDE, NEWCASTLE UPON TYNE, NE1 3DY, 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 |
| 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 |
| 3.3 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