Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 25043 |
| 2. Name of Authorisation Holder | ASTELLAS PHARMA EUROPE LIMITED |
| 3. Legally registered address of Authorisation Holder | ASTELLAS PHARMA EUROPE LIMITED, 300 DASHWOOD LANG ROAD, BOURNE BUSINESS PARK, ADDLESTONE, KT15 2NX, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
ASTELLAS PHARMA EUROPE LIMITED, 300 DASHWOOD LANG ROAD, BOURNE BUSINESS PARK, ADDLESTONE, KT15 2NX, UNITED KINGDOM ASTELLAS PHARMA EUROPE LIMITED, 200 DASHWOOD LANG ROAD, BOURNE BUSINESS PARK, ADDLESTONE, KT15 2NX, 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 | 27/09/2022 |
| 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:
ASTELLAS PHARMA EUROPE LIMITED, 300 DASHWOOD LANG ROAD, BOURNE BUSINESS PARK, ADDLESTONE, KT15 2NX, 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) |
| 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 |
| 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
Name and address of the site:
ASTELLAS PHARMA EUROPE LIMITED, 200 DASHWOOD LANG ROAD, BOURNE BUSINESS PARK, ADDLESTONE, KT15 2NX, 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) |
| 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 |
| 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