Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 25044 |
|---|---|
| 2: Name of authorisation holder | BDD PHARMA LIMITED |
| 3: Address(es) of manufacturing site(s) |
BDD PHARMA LIMITED, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, UNITED KINGDOM BDD PHARMA LIMITED, BIO-IMAGING CENTRE, BASEMENT MEDICAL BLOCK WITHIN GLASGOW ROYAL INFIRMARY, 84 CASTLE STREET, GLASGOW, G4 0SF, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | BDD PHARMA LIMITED, BIO-IMAGING CENTRE, BASEMENT MEDICAL BLOCK WITHIN GLASGOW ROYAL INFIRMARY, 84 CASTLE STREET, GLASGOW, G4 0SF, UNITED KINGDOM |
| 5: Scope of authorisation and dosage forms | ANNEX 1 and/ or ANNEX 2 |
| 6: Legal Basis of authorisation | |
| 7: Name of responsible officer of the competent authority of the member state granting the manufacturing authorisation | Confidential |
| 8: Authorisation Date | 01/07/2025 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
BDD PHARMA LIMITED, BIOCITY SCOTLAND, BO'NESS ROAD, MOTHERWELL, ML1 5UH, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.2 ] Capsules, soft shell |
| [ 1.2.1.5 ] Liquids for external use |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.9 ] Pressurised preparations |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.2.1.13 ] Tablets Special Requirements Melatonin |
| [ 1.2.1.15 ] Other non-sterile medicinal products Manufacture of intermediates, Overencapsulation,Buccal film, Any authorised products listed above may incorporate radiolabel and may contain biotechnology |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.5 ] Biotechnology products Special Requirements Use of Biotechnology drug substance, blend or intermediate in manufacture of non-sterile finished dosage form |
| [ 1.3.1.8 ] Other biological medicinal products Any authorised products listed above may incorporate radiolabel. Radiolabelling of pre-formulated biological medicinal products. |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.5 ] Biotechnology products Special Requirements Use of Biotechnology drug substance, blend or intermediate in manufacture of non-sterile finished dosage form |
| [ 1.3.2.8 ] Other biological medicinal products Any authorised products listed above may incorporate radiolabel. Radiolabelling of pre-formulated biological medicinal products. |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.9 ] Pressurised preparations |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.15 ] Other non-sterile medicinal products Buccal films, ntermediates, Overencapsulated products, Radio-labelled products |
| [ 1.5.2 ] Secondary packaging |
| [ 1.6 ] Quality control testing |
| [ 1.6.3 ] Chemical/Physical |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |
| [ 2.3.4 ] Other Importation of QP certified IMPs from the "approved countries for import" list |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
BDD PHARMA LIMITED, BIO-IMAGING CENTRE, BASEMENT MEDICAL BLOCK WITHIN GLASGOW ROYAL INFIRMARY, 84 CASTLE STREET, GLASGOW, G4 0SF, UNITED KINGDOM
Human Investigational Medicinal Products
| Authorised Operations |
| MANUFACTURING OPERATIONS (according to part 1)IMPORTATION OF MEDICINAL PRODUCTS (according to part 2) |
| Part 1 - MANUFACTURING OPERATIONS |
| [ 1.2 ] Non-sterile investigational medicinal products |
| [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) |
| [ 1.2.1.1 ] Capsules, hard shell |
| [ 1.2.1.2 ] Capsules, soft shell |
| [ 1.2.1.5 ] Liquids for external use |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.9 ] Pressurised preparations |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.2.1.13 ] Tablets Special Requirements Melatonin |
| [ 1.2.1.15 ] Other non-sterile medicinal products Buccal film/ Any Authorised products listed above may be radiolabelled and contain biotechnology |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.5 ] Biotechnology products Special Requirements Radiopharmaceuticals |
| [ 1.3.2 ] Batch certification |
| [ 1.3.2.5 ] Biotechnology products Special Requirements Radiopharmaceuticals |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.9 ] Pressurised preparations |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.15 ] Other non-sterile medicinal products radio-labelled products/ Buccal Film |
| [ 1.5.2 ] Secondary packaging |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.5 ] Biotechnology products |
| [ 2.3 ] Other Importation Activities |
| [ 2.3.1 ] Site of Physical Importation |
| [ 2.3.2 ] Importation of Intermediate which undergoes further processing |
| [ 2.3.4 ] Other mportation of QP certified IMPs from the "approved countries for import" |