MANUFACTURING SITE REGISTRATION WITH MOH-UAE
Manufacturing Site Registration MOHAP -UAE
For the Ministry of Health and Prevention registered products, the Company and Manufacturing Sites must be registered by the Ministry of Health and Prevention. Company and site registration takes around 4-6 months. Registration of company, sites as well as products with the Ministry of Health and Prevention are valid for 5 years after that renewal must be done.
Application is collected from the Technical Affairs Section Secretary or downloaded from the Ministry of Health site, the structures are part 1 (for Marketing Authorization Holder MAH) and part 2 (for manufacturing site), toward the end of each structure there is a list of documents that are required to be attached alongside the structure, the applications must be filled as well as stamped.
Stage 1: Site Assessment
A complete review of the quality systems in place at the facility has to be undertaken. This is completed by an electronic/paper audit and physical audit.The Site Assessment includes:
- RM (Raw Material) Evaluation at all Production/Packing Site
- RM (Raw Material) Supplier Assessment Process
- Certificate as well as standard operating procedure (SOP) review for each production/storage areas/packing
Stage 2: Pre-Registration Sample/Swab Testing
During the Site Assessment Procedure, various samples/swabs are collected from several critical control points. These samples/swabs are tested at LGC to guarantee that there is no sign of contamination issues with prohibited substances at the site.
At first, at least 20 samples/swabs are collected and tested. Analysis time is regularly 7-10 working days from receipt at the lab, and results shall be reported to the prospective member by a COA (Certificate of Analysis)
Stage 3: Post-Registration Requirements
When Stages 1 and 2 are completed, and the necessities of Informed-Choice have been met, the site will be accepted for the registration with the Informed-Choice. A license agreement shall be given, which allows the new member company to use the Informed-Choice logo in relationship with the registered site. The site that is registered will be listed on the Informed-Choice website, alongside a link to the member company’s website.
Post-Registration Site Visits and Testing
When registered, the member company shall be physically audited twice a year to guarantee that compliance with the Informed-Choice program is maintained. These on-site visits include a review of the process being followed, and checks to guarantee that any changes in the process have been assessed and captured. Further samples/swabs are collected during the six-monthly audit. These are then analyzed at LGC to guarantee there is no sign of trace contamination with prohibited substances at the site. At least 10 samples/swabs are collected during the six-monthly site visits.
Note: Site registration doesn’t imply that finished products have been tested, but instead that the site itself has been tested to show that it has appropriate controls in place to minimize cross-contamination with banned substances.
A complete review of the quality systems in place at the facility is then undertaken. This is completed by a paper audit and a physical audit. The aim of this preregistration audit is to guarantee that the facility is following good manufacturing practices. Specific attention is made to fill the “gap” between where standard good manufacturing practice necessities end and sports anti-doping practices start. A definitive target is to guarantee that preventative measures are in place to minimize contamination of an ingredient/product with a prohibited substance.The Site Assessment includes a review of certificates of accreditation held by the facility, a careful review of the standard operating process in place at the facility, a complete review of each raw materials handled on-site as well as an assessment of likely risks regarding prohibited substance contamination, etc
Throughout the review any remedial actions that are discussed with the company willing to register its site. When these remedial actions had been addressed the registration procedure can proceed.
The Site Assessment is completed via trained staff at LGC, a world-class sports anti-doping laboratory. LGC has more than 50 years of expertise in anti-doping in sport as well as has published more than 300 scientific papers on methods it had developed for the detection of trace levels of substances that are prohibited in sport. LGC has more than 450 man-years of research into sports doping control.
The Site Assessment involves:
- Raw Material (RM) Evaluation
- Raw Material Supplier Assessment Procedures
- Certificate and SOP Review for all Production/Packing/Storage Areas