Medicines and Healthcare products Regulatory Agency
CERTIFICATE NUMBER : UK API 298 Insp GMP 298/32735921-0003
Certificate of GMP Compliance Of A Manufacturer(1),(2)
Part 1
Issued following an inspection in accordance with :
Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)
The competent authority of United Kingdom confirms the following :
The Manufacturer :
WELEDA UK LIMITED
Site address :
WELEDA UK LIMITED,
UNIT 2, ETIQUETTE PARK,
MANNERS AVENUE,
ILKESTON,
DE7 8FU,
UNITED KINGDOM
Is an active substance manufacturer that has been inspected in accordance with Regulation 327 of The Human Medicines Regulations 2012 (SI 2012/1916).
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 13/05/2026, it is considered that it complies with
- The principles of GMP for active substances referred to in Regulation B17 and C17 of the Human Medicines Regulations 2012 (SI 2012/1916)
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. This certificate is valid only when presented with all pages and both Parts 1 and 2. The authenticity of this certificate may be verified in MHRA-GMDP. If it does not appear, please contact the issuing authority.
- (1) Guidance on the interpretation of this template can be found in the Help menu of MHRA-GMDP database.
- (2) These requirements fulfil the GMP recommendations of WHO.
Part 2
Human Medicinal Products
Manufacture of active substance. Names of substances subject to inspection:
- [4000015554] THUJA OCCIDENTALIS 33% MOTHER TINCTURE
- [4000016077] HUMULUS LUPULUS 10% MOTHER TINCTURE
- [2000019278] ARNICA PLANTA TOTA 50% MOTHER TINCTURE
- [2000019280] CHAMOMILLA RADIX 10% MOTHER TINCTURE
- [2000019283] HYPERICUM 33% PLANTA TOTA MOTHER TINCTURE
- [2000019276] ALLIUM CEPA 50% MOTHER TINCTURE
- [2000019285] ANGELICA ARCHANGELICA ROOT PH EUR
- [2000019284] NATRUM MURIATICUM 10% MOTHER TINCTURE
- [2000019286] BELLADONNA 50% MOTHER TINCTURE
- [4000015553] RUTA GRAVEOLENS 33% MOTHER TINCTURE
- [2000019904] VALERIANA OFFICINALIS 10% MOTHER TINCTURE
- [4000015551] CALENDULA OFFICINALIS 50% MOTHER TINCTURE
- [2000019281] MATRICARIA CHAMOMILLA 33% MOTHER TINCTURE
- [2000019903] AVENA SATIVA 50% MOTHER TINCTURE
- [4000015552] RHUS TOXICODENDRON 50% MOTHER TINCTURE
- [4000015549] ACONITUM NAPELLUS 50% MOTHER TINCTURE
- [1000020699] WEED, GRASS, CEREALS AND TREE MIXED POLLEN WELEDA
- [2000019282] HYPERICUM PERFORATUM 33% MOTHER TINCTURE
- [2000019277] ARGENTUM NITRICUM 10% MOTHER TINCTURE
- [4000015550] ARNICA MONTANA 33% MOTHER TINCTURE
- [4000016078] PASSIFLORA INCARNATA 33% MOTHER TINCTURE
- [2000019287] KALIUM PHOSPHORICUM 1% MOTHER TINCTURE
| 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES | |
| THUJA OCCIDENTALIS 33% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| HUMULUS LUPULUS 10% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| ARNICA PLANTA TOTA 50% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| CHAMOMILLA RADIX 10% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| HYPERICUM 33% PLANTA TOTA MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| ALLIUM CEPA 50% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| ANGELICA ARCHANGELICA ROOT PH EUR | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Drying, grinding | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| NATRUM MURIATICUM 10% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.4 Mineral Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| BELLADONNA 50% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| RUTA GRAVEOLENS 33% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| VALERIANA OFFICINALIS 10% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Pressing, Filtering | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| CALENDULA OFFICINALIS 50% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| MATRICARIA CHAMOMILLA 33% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| AVENA SATIVA 50% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| RHUS TOXICODENDRON 50% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| ACONITUM NAPELLUS 50% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| WEED, GRASS, CEREALS AND TREE MIXED POLLEN WELEDA | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.2.6 Purification of extracted substance | |
| 3.5 | General Finishing Steps |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| HYPERICUM PERFORATUM 33% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| ARGENTUM NITRICUM 10% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.4 Mineral Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| ARNICA MONTANA 33% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| PASSIFLORA INCARNATA 33% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.1 Plant Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Press, filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| KALIUM PHOSPHORICUM 1% MOTHER TINCTURE | |
| 3.2 | Processing Activities of Active Substance from Natural Sources |
| 3.2.4 Mineral Source Extraction | |
| 3.5 | General Finishing Steps |
| 3.5.1 Physical Processing Steps Filtration | |
| 3.5.2 Primary Packaging | |
| 3.6 | Quality Control Testing |
| 3.6.1 Physical / Chemical testing | |
| 13/07/2026 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |