Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 21678 |
| 2. Name of Authorisation Holder | BETA PHARMACEUTICALS LIMITED |
| 3. Legally registered address of Authorisation Holder | BETA PHARMACEUTICALS LIMITED, EASTWAYS INDUSTRIAL ESTATE, 154 ENTERPRISE COURT, WITHAM, CM8 3YS, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
BETA PHARMACEUTICALS LIMITED, UNITS 7 & 8, SWANBRIDGE INDUSTRIAL PARK, BLACK CROFT ROAD, WITHAM, CM8 3YN, UNITED KINGDOM BETA PHARMACEUTICALS, 154 ENTERPRISE COURT, EASTWAYS INDUSTRIAL ESTATE, WITHAM, CM8 3YS, UNITED KINGDOM BETA PHARMACEUTICALS LIMITED, UNIT 3, SWANBRIDGE INDUSTRIAL PARK, BLACK CROFT ROAD, WITHAM, CM8 3YN, UNITED KINGDOM BETA PHARMACEUTICALS LIMITED, UNIT 5, BELLCROFT, EASTWAYS INDUSTRIAL ESTATE, WITHAM, CM8 3YU, 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 | 23/07/2024 |
| 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 |
BETA PHARMACEUTICALS LIMITED, UNITS 7 & 8, SWANBRIDGE INDUSTRIAL PARK, BLACK CROFT ROAD, WITHAM, CM8 3YN, 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 |
| 1.4 With a Marketing Authorisation in EEA member state(s) and intended for the GB parallel import market |
| 2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS |
| 2.1 Procurement |
| 2.2 Holding |
| 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 |
| 3.1.1 Narcotic or psychotropic products |
| 3.1.3 Immunological medicinal products |
| 3.3 Cold chain products (requiring low temperature handling) |
BETA PHARMACEUTICALS, 154 ENTERPRISE COURT, EASTWAYS INDUSTRIAL ESTATE, WITHAM, CM8 3YS, 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 |
| 2.2 Holding |
| 2.3 Supply |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.1 Narcotic or psychotropic products |
| 3.3 Cold chain products (requiring low temperature handling) |
BETA PHARMACEUTICALS LIMITED, UNIT 3, SWANBRIDGE INDUSTRIAL PARK, BLACK CROFT ROAD, WITHAM, CM8 3YN, 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 |
| 2.2 Holding |
| 2.3 Supply |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.1 Narcotic or psychotropic products |
| 3.1.3 Immunological medicinal products |
| 3.3 Cold chain products (requiring low temperature handling) |
BETA PHARMACEUTICALS LIMITED, UNIT 5, BELLCROFT, EASTWAYS INDUSTRIAL ESTATE, WITHAM, CM8 3YU, 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 |
| 2.2 Holding |
| 2.3 Supply |
| 3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS |
| 3.1.1 Narcotic or psychotropic products |