• Power of Attorney granted by the Manufacturer or owner of the product. The document must be legalized before a Panamanian Consul or Carry the Apostille Seal.
• Certificate of Free Sale. This document must establish that the product is either authorized to be sale at the country of origin or that is sold on this country. It must include the following information:

a)    Name of the product and pharmaceutical form/presentation.
b)    It cannot be older than two years.
c)    Commercial name of the product or brand and all its references.
d)    Name of the manufacturer, country of origin and name of the foreign agent in charge of commercialization.

• Cuali-cuantitative formula duly signed by the responsible of the manufacturer’s laboratory.  The formula must declare all the ingredients according the INCI or the  DCI. It must also include the name of the product and all references. If any color is used on the formula, it must have the International Color Index Number.
• Two original samples per reference. The sample must have the batch number and expiration date stamped on the label. (For renewal the product must have the registry number stamped on the label).
• Two labels in Spanish or information enclosed.
• Finished Product Specifications: physical, chemical and microbiological specifications.
• Analytical Method
• Certificate of analysis
• Documents to support any special quality of the product such as, disinfectant, 1 month durability, effective in one hour, etc..
• Certificate of Good Manufacturers Practice issued by the sanitary authority on behalf of the manufacturer. This document must be legalized and may be used for two years, unless the document establishes another expiration date.
• 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:

• Analysis Fee ......................................................................US$350.00 aprox.
• Sanitary Registration Fee ......................................................US$200.00
• Goverment 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.