Medicines and Healthcare products Regulatory Agency
| 1: Authorisation Number | UK MIA(IMP) 4757 |
|---|---|
| 2: Name of authorisation holder | SIMBEC RESEARCH LIMITED |
| 3: Address(es) of manufacturing site(s) |
SIMBEC RESEARCH LIMITED, SIMBEC HOUSE, MERTHYR TYDFIL INDUSTRIAL PARK, MERTHYR TYDFIL, CF48 4DR, UNITED KINGDOM |
| 4: Legally registered address of authorisation holder | SIMBEC RESEARCH LIMITED, SIMBEC HOUSE, MERTHYR TYDFIL INDUSTRIAL PARK, MERTHYR TYDFIL, CF48 4DR, 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 | 09/07/2024 |
| 9: Annexes attached | Annex 1 and/or Annex 2 |
SCOPE OF AUTHORISATION
Annex 2
Name and address of the site:
SIMBEC RESEARCH LIMITED, SIMBEC HOUSE, MERTHYR TYDFIL INDUSTRIAL PARK, MERTHYR TYDFIL, CF48 4DR, 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 |
| [ 1.1 ] Sterile Investigational Medicinal Products |
| [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) |
| [ 1.1.1.1 ] Large volume liquids |
| [ 1.1.1.4 ] Small volume liquids |
| [ 1.1.1.5 ] Solids and implants |
| [ 1.1.1.6 ] Other aseptically prepared products Radiopharmaceuticals small and large volume liquids.Antibodies/other therapeutic proteins.Non live protein based vaccine |
| [ 1.1.3 ] Batch certification |
| [ 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 |
| [ 1.2.1.5 ] Liquids for external use |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.9 ] Pressurised preparations |
| [ 1.2.1.15 ] Other non-sterile medicinal products Solutions for inhalation/nebulisation, Radiopharmaceuticals (solids, oral solutions, solutions for inhalation/nebulisation). Dry powder for nasal inhalation. Pressurised preparations, specifically radiolabelled products, Oral Powders |
| [ 1.2.2 ] Batch certification |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.8 ] Other biological medicinal products Packaging of dry powder nasal sprays including hGH, Dilution of oral liquid vaccines containing genetically modified live bacteria. |
| [ 1.4 ] Other investigational medicinal products or manufacturing activitiy |
| [ 1.4.1 ] Manufacture of: |
| [ 1.4.1.2 ] Homoeopathic products |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.3 ] Chewing gums |
| [ 1.5.1.4 ] Impregnated matrices |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.12 ] Suppositories |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.14 ] Transdermal patches |
| [ 1.5.1.15 ] Other non-sterile medicinal products Solutions for inhalation/nebulisation, Radiopharmaceuticals (solids, oral solutions, solutions for inhalation/nebulisation). Dry powder for nasal inhalation. Pressurised preparations, specifically radiolabelled products, Oral Powders |
| [ 1.5.2 ] Secondary packaging |
| Part 2 - IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.1 ] Sterile Products |
| [ 2.2.1.1 ] Aseptically prepared |
| [ 2.2.1.2 ] Terminally sterilised |
| [ 2.2.2 ] Non-sterile 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 Radiopharmaceuticals/radionuclide generators/ Importation of QP certified IMPs from a country on the approved country for import list |