Electronic application form.

CD with all documents and information, such as eCTD.

In the absence of eCTD of the product, the CD should contain:

• Certificate of final product analysis for three batches.

• Certificate of analysis of standard substances if the compound contains a therapeutic substance.

• Statement of composition certificate, listing the active and inactive ingredients, their concentrations and specifications.

• Certificate of final product specifications.

• Statement of method of analysis of final product and test validation methods (validation report for test methods).

• Analysis certificate of active and inactive ingredients in the finished product.

• If the analysis is constitutional, a copy of the most recent version of the constitution must be attached.

• When high-performance liquid chromatography (HPLC) or gas chromatography (GC) are used in analysis, the chromatogram must be provided, and evidence of other methods, such as FTIR, TLC and UV spectrum, should also be provided.

Standard samples and materials:

• A sufficient number of samples of the final product (enough to analyze the product three times) must be provided.

• Primary reference standard as USP and EP.

• Working standard with an attached certificate of analysis of all details.

• Related substance and degradation product standard for the active and preservative ingredients.

• If a special type of HPLC column was used, this must be provided to the laboratory.

External packaging of the product and the enclosed leaflet, including all necessary data (batch number, date of manufacture and validity, storage conditions, name of commercial compound, name of manufacturer and country of origin, directions for use, capacity or volume, drug code if applicable, and any necessary warnings) must be provided.

Copy of outer packaging.

Copy of internal leaflet.

The technical file should consist of three main parts: analysis, stability study, and bioavailability and equivalence study (for chemical and biopharmaceuticals only), and should be submitted to the Drug Registration Department.

The drug's uses should be clarified.

The quantity of the sample should be sufficient, as per the requirements of the pharmaceutical form.