Medicines and Healthcare products Regulatory Agency
Certificate of GMP Compliance Of A Manufacturer(1),(2)
Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)
The competent authority of United Kingdom confirms the following :Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA(IMP) 25044 in accordance with Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 14/05/2020, it is considered that it complies with
- The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17 of the Human Medicines Regulations 2012 (as amended)
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.
| 1. MANUFACTURING OPERATIONS |
| [ 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 |
| [ 1.2.1.2 ] Capsules, soft shell |
| [ 1.2.1.4 ] Impregnated matrices |
| [ 1.2.1.5 ] Liquids for external use |
| [ 1.2.1.6 ] Liquids for internal use |
| [ 1.2.1.7 ] Medicinal gases |
| [ 1.2.1.8 ] Other solid dosage forms |
| [ 1.2.1.9 ] Pressurised preparations |
| [ 1.2.1.11 ] Semi-solids |
| [ 1.2.1.12 ] Suppositories |
| [ 1.2.1.13 ] Tablets |
| [ 1.2.1.14 ] Transdermal patches |
| [ 1.2.1.17 ] Other non-sterile medicinal productsBuccal film |
| [ 1.3 ] Biological investigational medicinal products |
| [ 1.3.1 ] Biological medicinal products |
| [ 1.3.1.5 ] Biotechnology productsSpecial Requirements Radiopharmaceuticals |
| [ 1.5 ] Packaging |
| [ 1.5.1 ] Primary packaging |
| [ 1.5.1.1 ] Capsules, hard shell |
| [ 1.5.1.2 ] Capsules, soft shell |
| [ 1.5.1.4 ] Impregnated matrices |
| [ 1.5.1.5 ] Liquids for external use |
| [ 1.5.1.6 ] Liquids for internal use |
| [ 1.5.1.7 ] Medicinal gases |
| [ 1.5.1.8 ] Other solid dosage forms |
| [ 1.5.1.9 ] Pressurised preparations |
| [ 1.5.1.11 ] Semi-solids |
| [ 1.5.1.12 ] Suppositories |
| [ 1.5.1.13 ] Tablets |
| [ 1.5.1.14 ] Transdermal patches |
| [ 1.5.1.17 ] Other non-sterile medicinal productsradio-labelled products/ Buccal Film |
| [ 1.5.2 ] Secondary packaging |
| 2. IMPORTATION OF MEDICINAL PRODUCTS |
| [ 2.2 ] Batch certification of imported medicinal products |
| [ 2.2.3 ] Biological medicinal products |
| [ 2.2.3.5 ] Biotechnology products |
| 22/05/2020 | Name and signature of the authorised person of the Competent Authority of United Kingdom |
| Confidential | |
| Medicines and Healthcare products Regulatory Agency | |
| Tel : Confidential |