Samples, and standard and reference materials for the product to be analyzed.

Receipt of payment of analysis fee (or electronic application number with proof of payment of service fee).

Receipt of payment of examination certificate issuance fee (or electronic application number with proof of payment of service fee).

CD with all documents and information, such as eCTD.

In the absence of eCTD of the product, the CD must 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, including active and inactive ingredients, their concentrations and specifications.

• Certificate of final product specifications.

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

• Analysis certificate for 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) is used for analysis, the chromatogram must be attached, and evidence should also be provided when other methods, such as FTIR, TLC and UV spectrum, are used.

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, such 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, it 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.

All data must be provided in Arabic and English.

The approval of the Director of Drug Administration for re-examination of new samples is required.