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Legislation

December 1, 2022
A A
Rules:
On approval of the “Rules for state registration and maintenance of the register of medicines”
RULES for state registration and maintenance of the register of medicines
List of documents required for registration of changes in medicinal product
Rules for the expertise of medicinal product
About approval of “Rules of expertise of biologically active food additives”
RULES for examination of biologically active food supplements
Annexes:
Annex 1. Application for state registration of a medicinal product
                 Letter of application for state registration of the medicinal product
                 Letter of application for re-registration of the medicinal product
                 Letter of application for state registration of changes in the registration documents of the medicinal product
Annex 2.  Application for state registration of API (Active pharmaceutical ingredient) in the Republic of Azerbaijan
Annex 3. Documents for registration of medicinal product produced in a foreign country
Annex 4.   Documents for registration of API (Active pharmaceutical ingredient)
Annex 5.   Documents for registration of domestically produced API (Active pharmaceutical ingredient)
Annex 6. Documents for re-registration  of medicinal product produced in a foreign country
Annex 7.  Documents for Re-registration of domestically produced API (Active pharmaceutical ingredient)
Annex 8. List of requirements for medicinal product labeling
Annex 9.  List of requirements for instructions for use of the medicinal product
Annex 10. List of requirements for instructions on the use of medicinal product (for consumers)
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No Result
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  • About Us
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    • Department of Registration
    • Legislation
  • Laboratory
    • About the Quality Control Laboratory
  • Pharmacovigilance
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    • Legislation
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    • Information for Patients
    • Pharmacovigilance dictionary
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    • For MAH
  • Private medical institutions
    • Legislation
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