Tashkent,
Yunusabad district, Ming urik St. 2
RuEn

Registration of medicines, vaccines, medical devices and medical equipment

Specialist's Assistance
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Our Services
  • Registration of medicines and vaccines
    • Registration services for medical devices and medical equipment
      • Obtaining an import permit and attendance during trials of food supplements and additives
        • Preparation of instructions for the medical use of drugs in the state language.
          • Introducing amendments to the registration certificate and registration dossier
            • Other consulting services on regulatory issues
              While attempting to register product on one’s own, clients frequently encounter following problems:

              Massive workload with a lot of unknown details may cause mistakes and loss of resources. 

              Frequent issues with regulations .

              Lack of deep understanding of communications established in the local agencies can result in registration’s cancellation, which also costs resources and time.

              Benefits of registration with Supra Labs

              We take on all the paperwork and provide advisory support for any questions related with registration of medicines, vaccines, medical devices and medical equipment.
              Our team is well informed and experienced with every aspect of registration in Uzbekistan. We are ready to address any potential issue.
              Individual and exclusive approach to every project. We know what is required to succeed in obtaining a certificate for any given product, which allows us to make the process as efficient as possible
              Warranty of confidentiality and close control of registration process till the end.

              About Us

              Supra Labs LLC offers a wide range of consulting and information services for registration/renewal of medicines, medical devices, medical equipment and food supplements in the territory of the Republic of Uzbekistan. Our company also participates in areas of distribution and sale of all aforementioned products. 

              We represent your interests in the state bodies of the Ministry of Health of the Republic of Uzbekistan from the moment of submission of documents to the transfer of the registration certificate to you. Thus, we guarantee complete and high quality support, as well as  adherence to deadlines and proper process control. 

              High professionalism and extensive experience of our regulatory team allow us to find a multilateral approach to solving the tasks in hand quickly, as well as resolving any possible issues.

              We maintain the regulatory status of more than 60 registration certificates for medicines and medical devices of companies from the EU and the Middle East.

              Registration Steps

              The purpose of registration is to provide the local market with safe, effective and high-quality medical products.

              Throughout the process of registration, the product is assessed on the matter of conformity with declared characteristics, it passes clinical trials and undergoes laboratory and experts’ assessment to check for any potential health risks it may pose.

              Registration of medicines, medical devices and medical equipment consists of the following steps:
               
              1
              Filling an application form on our website
              Preparation of a dossier as per regulation
              2
              Submission of  application to the Regulatory Authority (RA)
              3
              Initial assessment of the dossier
              4
              Quality control conducted by laboratory of RA
              5
              Expert assessment of quality, safety and effectiveness of medicine
              6
              Obtaining a registration certificate
              Questions and answers
              What needs registration?
              According to ministry’s decree №213, subjects to state registration in are:

              - Medicines
              - Medical devices
              - Medical equipment.
              - New combinations of medicines previously registered in Uzbekistan;
              - Pharmaceuticals, previously registered in Uzbek Republic, but produced with a new medical form, dosage or different manufacturer;
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              Which products can’t be registered?
              It is prohibited to register two or more medicines with different medical substances under the same trademark. It is also prohibited to register medicines of one manufacturer under different trademarks if their contents are the same.
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              What doesn’t require registration?

              Medical products and medical devices made in pharmacies, as well as products imported to act as samples for scientific projects, clinical trials and tests, don’t require registration. Same goes for medicines and medical equipment brought to Uzbekistan for the purpose of being displayed on international forums/exhibitions.

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              What can cause a suspension or withdrawal of registration certificate?
              Evasion of regulatory authority-run inspections of compliance with permit requirements and conditions.

              Detection of harm to life and health of consumers after use of approved products.
               
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              How long does it take for the registration application to be reviewed?
              An application for the issue of registration certificate is considered by the regulatory authority within a period not exceeding:
              50 days — for medical substances (API);
              120 days — for medicines in the form in bulk and packaged pharmacopoeial medicinal plant materials, dressing materials, products for punctures, injections, transfusions and suction, contraceptives, rubber, rubber-latex, latex, polymer medical products, medical products for first aid, patient care items;
              155 days — for other medicines, medical products and medical equipment.
              Attention! It is important to note that these terms do not include:
              - 45 days to eliminate the deficiencies identified during the expertise of the submitted documentation of the medicinal product, medical device and medical equipment;
              - 45-day period for submission of samples for clinical trials
              - The duration of clinical trials, which is no more than 3 years for original medicines and 1 year for generics. The clinical trials are not carried out to register substances.
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              What is the validity period of a registration certificate?

              Registration certificate of medicines, medical products and medical equipment is issued for 5 years.


               
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              Request a service form
              Get a consultation on any number of questions concerning registration and renewal of medical products! Price and terms will be calculated upon analyzing your case.


               
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