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 1175 |
| 2. Name or corporate name of registrant | A NELSON AND COMPANY LIMITED |
| 3. Permanent or legal address of registrant | A NELSON AND COMPANY LIMITED, UNIT 1, UNIT 5-9 ENDEAVOUR WAY, LONDON, SW19 8UH, UNITED KINGDOM |
| 4. Address(es) of site(s) where registered activities take place |
A NELSON AND COMPANY LIMITED, UNIT 1, UNIT 5-9 ENDEAVOUR WAY, LONDON, SW19 8UH, 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 | 05/04/2022 |
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
A NELSON AND COMPANY LIMITED, UNIT 1, UNIT 5-9 ENDEAVOUR WAY, LONDON, SW19 8UH, UNITED KINGDOM
1. MANUFACTURING OPERATIONS
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.1 Plant Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| B | Extraction of Active Substance from Natural Sources |
| B.2 Animal Source Extraction | |
| E | General Finishing Steps |
| E.1 Physical Processing Steps
As per HAB/GHP monograph. | |
| E.2 Primary Packaging | |
| E.3 Secondary Packaging | |
| F | Quality Control Testing |
| F.1 Physical / Chemical testing | |
| F.2 Microbiological testing (excluding sterility testing) |
| 2. IMPORTATION AND DISTRIBUTION OPERATIONS | |||
|---|---|---|---|
| A | Importation | ||
| Active Substance | 3rd Country Manufacturer | 3rd Country Distributor | |
| CHAMOMILLA RECUTITA (4000009468) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| ACIDUM ARSENICOSUM (3000010211) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| ARNICA MONTANA (2000015911) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| STRYCHNOS NUX-VOMICA (3000007953) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| THUJA OCCIDENTALIS (2000016235) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| PULSATILLA (1000000327) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| SULFUR (3000009578) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| ACONITUM NAPELLUS (2000015834) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| STRYCHNOS IGNATII (3000010349) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| RHUS TOXICODENDRON (2000012889) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| ATROPA BELLADONNA (1000009827) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| EUPHRASIA OFFICINALIS (2000011624) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| GELSEMIUM SEMPERVIRENS (2000011750) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| NATRUM CHLORATUM (3000009881) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||
| SEPIA OFFICINALIS (3000014402) | HERBAMED AG, AUSTRASSE 12, BUEHLER, CH-9055, SWITZERLAND |
||