Medicines and Healthcare products Regulatory Agency
REGISTRATION OF MANUFACTURER, IMPORTER OR DISTRIBUTOR OF ACTIVE SUBSTANCES TO BE USED AS STARTING MATERIALS IN MEDICINAL PRODUCTS FOR HUMAN USE
| 1. Registration Number | UK API 6183 |
| 2. Name or corporate name of registrant | AIR PRODUCTS PLC |
| 3. Permanent or legal address of registrant | AIR PRODUCTS PLC, 2 MILLENNIUM GATE, WESTMERE DRIVE, CREWE, CW1 6AP, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
AIR PRODUCTS PLC, SALTEND LANE, HEDON, HULL, HU12 8PP, UNITED KINGDOM AIR PRODUCTS PLC, MANCHESTER ROAD, CARRINGTON, MANCHESTER, M31 4TG, UNITED KINGDOM AIR PRODUCTS PLC, HAWKESWORTH ROAD, SOUTHMEAD INDUSTRIAL PARK, DIDCOT, OX11 7PG, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
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| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 06/07/2023 |
This registration form is valid only when presented with all pages. The authenticity of this registration form may be verified in MHRA-GMDP.
The registration holder referred to in section 2 shall communicate annually to the competent authority an inventory of the changes which have taken place as regards the information provided in this registration form. Any changes that may have an impact on the quality or safety of the listed active substances must be notified immediately.
SCOPE OF REGISTRATION
AIR PRODUCTS PLC, SALTEND LANE, HEDON, HULL, HU12 8PP, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| B | Extraction of Active Substance from Natural Sources |
| B.7 Other
CRYONIC DISTILLATION OF ATMOSPHERIC AIR Special Requirements Radiopharmaceuticals | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing
Special Requirements Live Cells |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| OXYGEN (1000009631) | |||
AIR PRODUCTS PLC, MANCHESTER ROAD, CARRINGTON, MANCHESTER, M31 4TG, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| B | Extraction of Active Substance from Natural Sources |
| B.7 Other
Cryogenic distillation of atmospheric air Special Requirements Other: Cryogenic distillation of atmospheric air | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| OXYGEN (1000009631) | |||
AIR PRODUCTS PLC, HAWKESWORTH ROAD, SOUTHMEAD INDUSTRIAL PARK, DIDCOT, OX11 7PG, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| B | Extraction of Active Substance from Natural Sources |
| B.7 Other
CRYONIC DISTILLATION OF ATMOSPHERIC AIR Special Requirements Other: Manufacture of medical gases by cryogenic distillation of atmospheric air | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| OXYGEN (1000009631) | |||