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SANITARY REGISTRATION OF RECOMBINANT DNA PRODUCTS, MONOCLONAL

ANTIBODIES AND THERAPEUTICS: CATEGORY A2

LEGALS
Legal documents executed in a foreign language must be translated into Spanish by a public
interpreter in Venezuela. Documents must be duly legalized, notarized or apostilled, as appropriate.

✓ Power of Attorney of the Sponsor

✓ Power of Attorney
✓ Certificate of Pharmaceutical Product / Certificate of Free Sale
✓ List of Countries in which the Product is Registered
✓ Certificate of Good Manufacturing Practice for the Active Ingredient Manufacturer
✓ Certificate of Good Manufacturing Practices for the Final Product Manufacturer
✓ Certificate of Good Manufacturing Practices of Conditioner
✓ Certificate of Installation and Operation of the House of Representation
✓ Certificate of Installation and Operation of the Warehouse
✓ Distributor's Certificate of Installation and Operation
✓ Proof of Adequate Storage Conditions
✓ Generic Name Recommendation
✓ Packaging Texts
✓ Label Texts and Self-Adhesive Label
✓ Text of the Internal Prospectus
✓ User's Manual Text
✓ Proposed Product Name

PHARMACEUTICAL CHEMIST
The information submitted must be in Spanish. In the case of being in another language, the
translation must be included.

✓ Data of the Agency responsible for the evaluation and approval of the Active Principle
✓ Description of the batch key of the active ingredient
✓ Description of the active ingredient
✓ List of manufactured products and cross-contamination precautions
✓ List of materials used in production
✓ Declaration of substances of animal and/or human origin used and their source of origin.
In case of not using substances of this type, a declaration of Non-use signed by the representative
of the Producing Laboratory or in its absence by the Pharmacist must be attached.
 Sponsor. Additionally, it must include at least one analytical certificate of the raw material used
and, if available, also include at least one certificate of release from the NRA of the country of
origin.
✓ Physical-Chemical Characterization/Biological Characterization. For both physical-chemical
and biological characterization you must indicate the number of lots evaluated in each case.
✓ Impurity profile
✓ Description of the starting materials (Therapeutic: attach information corresponding to the
culture medium and the obtaining of the active ingredient).
✓ Description of the manufacturing process of the Active Principle
✓ Active Principle Manufacturing Process Flowchart
✓ Description of the reprocessing step (as applicable, indicate the procedure to be followed and
criteria to be taken into account in case reprocessing of the active ingredient is required).
✓ List of Controls in the Active Ingredient Manufacturing Process.
✓ Analytical methods of the active ingredient
✓ Active ingredient specifications
✓ Analytical certificate for 3 batches of active ingredient
✓ Stability protocol for the active ingredient
✓ Results and conclusions of the stability study
✓ Shelf life for the active ingredient
✓ Details of the Agency responsible for the evaluation and approval of the Final Product
✓ Description of the batch key of the Final Product
✓ Function and Justification of the Ingredients used in the Quali-Quantitative Formula:
✓ Description of the Manufacturing Process of the Final Product
✓ Final Product Manufacturing Process Flowchart
✓ List of Controls in the Manufacturing Process of the Final Product
✓ Final Product Impurity Profile
✓ Final Product Analytical Methods
✓ Final Product Specifications
✓ Analytical Certificate(s) and Excipient(s) Specification(s)
✓ Analytical Certificate(s) and Condom Specification(s)
✓ Analytical Certificate(s) and Stabilizer Specification(s)
✓ Analytical Certificate(s) for 3 Batches of Final Product
✓ Final Product Stability Protocol
✓ Results and Conclusions of the stability study
✓ Validity period for the final product
PRE-CLINICAL AND GENERAL CLINICAL
✓ Summary statement
✓ Expert's report: Pharmaceutical Chemist
✓ Expert Report: Preclinical
✓ Expert Report: Clinical