Medicines and Healthcare products Regulatory Agency
WHOLESALE DISTRIBUTION AUTHORISATION
(MEDICINAL PRODUCTS FOR HUMAN USE)
| 1. Authorisation Number | UK WDA(H) 51381 |
| 2. Name of Authorisation Holder | ROYLANCE STABILITY STORAGE LIMITED |
| 3. Legally registered address of Authorisation Holder | ROYLANCE STABILITY STORAGE LIMITED, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, UNITED KINGDOM |
| 4. Address(es) of Site(s) |
ROYLANCE STABILITY STORAGE LIMITED (WISHAW), UNIT 1 EXCELSIOR PARK, NETHERTON INDUSTRIAL ESTATE, WISHAW, ML2 0EG, UNITED KINGDOM ROYLANCE STABILITY STORAGE LIMITED, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, UNITED KINGDOM ROYLANCE STABILITY STORAGE LIMITED, ELPHINSTONE SQUARE, DEANS INDUSTRIAL ESTATE, LIVINGSTONE, EH54 8RG, 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 | 18/03/2025 |
| 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 |
ROYLANCE STABILITY STORAGE LIMITED (WISHAW), UNIT 1 EXCELSIOR PARK, NETHERTON INDUSTRIAL ESTATE, WISHAW, ML2 0EG, 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 |
| 2.6 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 |
| 3.1.3 Immunological medicinal products |
ROYLANCE STABILITY STORAGE LIMITED, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, 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 |
| 2.6 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 |
| 3.1.3 Immunological medicinal products |
| 3.3 Cold chain products (requiring low temperature handling) |
ROYLANCE STABILITY STORAGE LIMITED, ELPHINSTONE SQUARE, DEANS INDUSTRIAL ESTATE, LIVINGSTONE, EH54 8RG, 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 |
| 2.6 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 |
| 3.1.3 Immunological medicinal products |
| 3.3 Cold chain products (requiring low temperature handling) |