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 8801 |
| 2. Name or corporate name of registrant | BIO PRODUCTS LABORATORY LIMITED |
| 3. Permanent or legal address of registrant | BIO PRODUCTS LABORATORY LIMITED, DAGGER LANE, ELSTREE, BOREHAMWOOD, HERTFORDSHIRE, WD6 3BX, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
BIO PRODUCTS LABORATORY LIMITED, DAGGER LANE, ELSTREE, BOREHAMWOOD, HERTFORDSHIRE, WD6 3BX, UNITED KINGDOM |
| 5. National legal basis of registration |
Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916)
|
| 6. Name of responsible officer of the competent authority of the member state validating the registration | Confidential |
| 7. Date | 06/02/2024 |
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
BIO PRODUCTS LABORATORY LIMITED, DAGGER LANE, ELSTREE, BOREHAMWOOD, HERTFORDSHIRE, WD6 3BX, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| B | Extraction of Active Substance from Natural Sources |
| B.3 Human Source Extraction | |
| E | General Finishing Steps |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) | |
| F.4 Biological Testing |
| B | Extraction of Active Substance from Natural Sources |
| B.3 Human Source Extraction | |
| E | General Finishing Steps |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) | |
| F.4 Biological Testing |
| B | Extraction of Active Substance from Natural Sources |
| B.3 Human Source Extraction | |
| E | General Finishing Steps |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) | |
| F.4 Biological Testing |
| B | Extraction of Active Substance from Natural Sources |
| B.3 Human Source Extraction | |
| E | General Finishing Steps |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) | |
| F.4 Biological Testing |
| B | Extraction of Active Substance from Natural Sources |
| B.3 Human Source Extraction | |
| E | General Finishing Steps |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) | |
| F.4 Biological Testing |
| B | Extraction of Active Substance from Natural Sources |
| B.3 Human Source Extraction | |
| E | General Finishing Steps |
| E.2 Primary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) | |
| F.4 Biological Testing |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
| B | Distribution | ||
| PURIFIED FACTOR IX INTERMEDIATE (4000016645) | |||
| HUMAN PROTHROMBIN COMPLEX (1000016178) | |||
| B+1 PASTE (1000017987) | |||
| FRACTION V (3000018085) | |||
| CRYOPRECIPITATE (1000017986) | |||
| FRACTION IV PASTE (1000017988) | |||