Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 19819 |
| 2. Name of Authorisation Holder | BIOTEC SERVICES INTERNATIONAL LIMITED |
| 3. Legally registered address of Authorisation Holder | BIOTEC SERVICES INTERNATIONAL LIMITED, BIOTEC HOUSE, CENTRAL PARK, WESTERN AVENUE, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3RT, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
BIOTEC SERVICES INTERNATIONAL LIMITED, UNITS 2100, 2110, 2120, 2130, 2010, 2430 AND 2500, PHASE 18, CENTRAL PARK, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3TY, UNITED KINGDOM BIOTEC SERVICES INTERNATIONAL LIMITED, BIOTEC HOUSE, CENTRAL PARK, WESTERN AVENUE, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3RT, 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 | 10/01/2022 |
| 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 |
BIOTEC SERVICES INTERNATIONAL LIMITED, UNITS 2100, 2110, 2120, 2130, 2010, 2430 AND 2500, PHASE 18, CENTRAL PARK, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3TY, 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 |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.1 Procurement |
| 2.2 Holding |
| 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 |
| 3.1.1 Narcotic or psychotropic products |
| 3.1.2 Medicinal products derived from blood |
| 3.2 Medicinal gases |
| 3.3 Cold chain products (requiring low temperature handling) |
BIOTEC SERVICES INTERNATIONAL LIMITED, BIOTEC HOUSE, CENTRAL PARK, WESTERN AVENUE, BRIDGEND INDUSTRIAL ESTATE, BRIDGEND, CF31 3RT, 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 |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.1 Procurement |
| 2.2 Holding |
| 2.3 Supply |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.1 Narcotic or psychotropic products |
| 3.1.2 Medicinal products derived from blood |
| 3.2 Medicinal gases |
| 3.3 Cold chain products (requiring low temperature handling) |