Your Guide to Uzbekistan
Here below we help you dive deep into the regulatory requirements of Uzbekistan and answer some of the basic questions.
Still confused with the complete process? - Genedrift assists you with all regulatory requirements as mentioned.
Guide to Drugs
The registration - from start to end !
The registration process is carried out with the departments within the Ministry of Health. The first requirement is to submit a full and complete dossier including translations upon which an invoice is received. The invoice is then paid in full by the MA Holder.
The MA Holder could be a foreign or domestic company and the amount may either be paid directly by the MA Holder or through us, locally, in currency equivalent with conversion rate.
Upon receipt of invoice, the application is then accepted for review. The review happens through three different wings each issuing their own queries and objections, which have to be responded to. While the Dossier is reviewed, the samples are analyzed by the designated lab and results received.
Upon successful review, the registration is announced and released along with the copy of the Certificate and Normative Document.
Site Audits are not mandatory, but may be triggered in case serious defaults are observed in the application.
Document - Checklist
The MOH follows a regional national checklist, created on basis of CTD.
The information relating to multiple strengths and multiple packing of the same generic may be added in the same dossier with additional Normative Documents.
MOH accepts minimum 6months of stability studies under Zone II B conditions.
Need our assistance ! We, at Genedrift can handle this for you.
Click here to download the checklist.
Guide to Food, Medical Devices, Cosmetics
The process for Food, Medical Devices and Cosmetics is different from Drugs and is taken care off by different departments within the MOH. The document requirement is comparatively less and the time too. The MOH issues a registration certificates for Medical Devices, valid for one to five years. The time period depends on various factors, including the product itself.
However, for Cosmetics, the permit is used for life-time.
The process is completely offline and paper based. The usual timelines vary, however, not exceeding 9 months in any of the category.
How can Genedrift help?
We file as your applicants
The law mandates that the filing has to be done through a local applicant. Although you remain the true applicant, we file and hold registrations on your behalf. You registrations remain in safe hands, while you have commercial agreements with anyone.
Timely Updates
Majority of FDA work is paper based, and delays are common throughout the process of the processing of applications. Each stage we ensure that applicant d requires a rigorous follow ups and ensuring that applications are not stuck. Once an update is received, we send it to you in within 48 hours
Safety of your Data
We ensure your Dossier is used only for MOH related activities. Complying with GDPR, we ensure that your data safe & secure. Our Data Centers comply with a minimum of ISO 27001, SOC 1 TYPE II, SOC 2 TYPE II
Pathway
Being locally present, we ensure that each and every application we handle for you is routed correctly through the right workflows at MOH ensuring least time in obtaining your certificates.
Are you a consultant yourself? Looking to use our services for your clients ?
We can get this done !!