• Power of Attorney granted by the Manufacturer and/or owner of the product.  The document must be legalized before a Panamanian Consul or carry the Apostille Seal.
• Free sale certificate, issued and signed by the health authority of the country of origin within the 6 months prior to the request.  The document must be duly legalized.
• Cuali-cuantitative formula of the product duly signed by the resposible of the laboratory.
• Elaboration method (only for vitaminic supplements)
• Certificate of analysis.
• Certificate of Good Manufacture Practices issued by the corresponding authority.
• Clinic studies for innovative products
• Bibliografic information (easey)
• Finished products specifications.
• Declaration of the pharmaceutic form / dosage form.
• Analytic Standards (must be accompanied by its certificate of analysis, batch code, expiration date and analysis date), when it is required.
• Two (2) lables (can be in serveral languages only if one of them are spanish)
• Six (6) samples of the product.  All of them must be from the same batch code and expiration date. 
• Explanation to interpret the batch code. 
• Shelf life of the product (expiration) and the stability test to prove the shelf life and the storage conditions of the product. 
• Information regarding the packaging material of the product.
  

Moreover, it is necessary to make an analysis of the samples you submit to us.  This analysis shall be paid to the government.

Following the estimate of expenses, without including phone calls, customs, legalization, copies and others:

•    Laboratory Analysis Fee  ........................................................US$400.00 aprox.
•    Sanitary Registry Fee ..............................................................US$200.00
•    Government Fee ......................................................................US$  25.00
•    Tax Stamps ..............................................................................US$   8.00
•    Signature of a Panamanian Pharmaceutics Professional............US$  50.00
•    Seal of the Panamanian College of Pharmaceutics...................US$  20.00

For further information, please do not hesitate to contact us.