Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 17907 |
| 2. Name of Authorisation Holder | BRISTOL LABORATORIES LIMITED |
| 3. Legally registered address of Authorisation Holder | BRISTOL LABORATORIES LIMITED, UNIT 3, CANALSIDE, NORTHBRIDGE ROAD, BERKHAMSTED, HP4 1EG, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
BRISTOL LABORATORIES LIMITED, UNIT 5, PREMIER BUSINESS PARK, DENCORA WAY, LUTON, LU3 3HP, UNITED KINGDOM BRISTOL LABORATORIES LIMITED, UNIT 9A AND 9B, PREMIER BUSINESS PARK, DENCORA WAY, LUTON, LU3 3HP, UNITED KINGDOM BRISTOL LABORATORIES LIMITED, UNIT 5, TRAYNOR WAY, WHITEHOUSE BUSINESS PARK, PETERLEE, SR8 2RU, UNITED KINGDOM BRISTOL LABORATORIES LIMITED, UNIT 3, CANALSIDE, NORTHBRIDGE ROAD, BERKHAMSTED, HP4 1EG, UNITED KINGDOM BRISTOL LABORATORIES LIMITED, UNIT 6, SOVEREIGN PARK, LAPORTE WAY, LUTON, LU4 8EL, 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 | 09/09/2024 |
| 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 |
BRISTOL LABORATORIES LIMITED, UNIT 5, PREMIER BUSINESS PARK, DENCORA WAY, LUTON, LU3 3HP, 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 |
| 2.5 Other ActivitiesDistribution |
| 2.6 Products imported from countries on a list |
| 2.6a Products certified under Article 51 of Directive 2001/83/EC |
BRISTOL LABORATORIES LIMITED, UNIT 9A AND 9B, PREMIER BUSINESS PARK, DENCORA WAY, LUTON, LU3 3HP, 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 |
| 2.5 Other ActivitiesDistribution |
| 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 |
BRISTOL LABORATORIES LIMITED, UNIT 5, TRAYNOR WAY, WHITEHOUSE BUSINESS PARK, PETERLEE, SR8 2RU, 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 |
| 2.5 Other ActivitiesDistribution |
| 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 |
BRISTOL LABORATORIES LIMITED, UNIT 3, CANALSIDE, NORTHBRIDGE ROAD, BERKHAMSTED, HP4 1EG, 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 |
| 2.2 Holding |
| 2.3 Supply |
| 2.5 Other ActivitiesDistribution |
| 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 |
BRISTOL LABORATORIES LIMITED, UNIT 6, SOVEREIGN PARK, LAPORTE WAY, LUTON, LU4 8EL, 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 |
| 2.5 Other ActivitiesDistribution |
| 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 |