State registration of medicinal products in Belarus

Step 1. You send a summary product characteristic (SmPC) indicating the country of registration, as well as the desired terms [normal procedure, express].

Step 2. Our experts carry out technical expertise of the documentation and determine the exact cost of the registration process of your medicinal product within 5 days.

Step 3. Having agreed on the price and terms, we conclude a cooperation agreement, as well as a confidentiality agreement.

Step 4. You prepare the documents according to the list and transfer them to us by any means convenient to you.

Step 5. Based on these documents, we create a registration dossier for submission to the State Pharmacological Center of the Ministry of Health of Belarus.

Step 6. Registration dossier is submitted to the State Pharmacological Center of the Ministry of Health of Belarus to examine the documents and confirm the quality of medicinal products.

Step 7. Upon finishing of the registration/ re- registration the original Registration certificate, approved instruction for medicinal use and approved analytical and normative documentation are issued.

Step 8. We transfer the original documents received to you.

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