Registration dossier for drug registration in Turkmenistan

List of documtation for drug registration in Turkmenistan:

  1. Summary about product, contaings brief information about each below point.
  2. Certificate of Pharmaceutical Product as recommended by the WHO, if not available –Marketing Authorisation Licence from the country of origin and other countries (notarized).
  3. GMP Certificate (notarized).
  4. Manufacturing licence (notarized).
  5. Summary of Product Characteristics (SPC) in English and Russian.
  6. Draft of the leaflet in Russian.
  7. Artwork components.
  8. Qualitative and quantitative composition of the medicinal product.
  9. Certificate of analysis (one batch).
  10. Normative document (specification and analytical procedures in Russian).
  11. Stability data.
  12. Bioavailability, bioequivalence (only if applicable, I suppose).
  13. Clinical pharmacology. Results of clinical trials, scientific publications and reports.
  14. Periodic safety update reports (renewal).
  15. Samples of medicinal product required to run the tests three times.
  16. Standard samples required to run the tests three times.