• 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.
• Analytic Method.  If the manufacturer uses a method from the pharmacopeias it will be enough to mention the name, edition and year.  On the contrary the manufacturer will need to file the physical-chemical, microbiologic an pharmacologic analytic method (as applicable)
• Certificate of Analysis:  Must incluye the following information:

a)  Name of the laboratory responsable for the analysis.
b)  Name and country of the manufacturer and the conditioning facility, if applicable.
c)  The comercial name of the finished product.
d)  The name of the active ingredients, as named by the DCI.
e)  Batch code of the sample analyzed (must match the simple sent for analysis)
f)   Manufacturer date, analysis date and expiration date.
g)  Description of the product
h)  Test made according to the dosage form.
i)   Results.
j)   Bibliographic referente of the analytic method used.
k)  Tolerante or aceptable limits
l)   Signatura of the person responbible of quality control.

• Certificate of  Free Sale  issued by the health authority of the manufacturing country or any type of World Health Organization.  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 that two years, unless the document provide a different date of expiration.
c)  Commercial name of the product  or brand and all its references.
d)  Name of the manufacturer, country of origin and, if applicable, the name of the third party in charge of conditioning or packing the product and its country.
e)  Must indicate the name of the active ingredients according the Common International Denomination (DCI), and its concentration (%).
f)   It must be legalized or apostilled.

• Certificate of Good Practices of Manufacture granted by a health authority of the country of origin to the manufacturer.
• Residuality and ecotoxicological studies of the product.
• Toxicological information of the producto
• Studies to prove Effectiveness 
• Bibliographic information of the product.
• Samples.  A minimum of 8 samples are required (all of them must be from the same batch code and need to have stamped on the bottle the expiration date and the batch code)
• Cuali-cuantitative formula, that must include the following:
  

a)  Signature of the head of the laboratory
b)  Name of the product
c)  Name and concentration of all the ingredients.
d)  When the ingredient is included as a salt and/or base must declare both concentrations.
e)  It must declare the color index (name and number) in the case of dyes.
f)   The excess of the formula must be declared
g)  The propellant shall be declared by name and concentration of each of the gases.  The gases can not affect the ozone layer.

• Stability test.  The tests must be made to three different batches.  The following tests are accepted:

a)    Real or natural stability test must be made at a temperature of 30ªC + 2ªC and relative humidity of 70% + 5% or other conditions applicable to climatic zone IV. The analysis shall be taken every three (3) months the first year and every six (6) months the second year, until is completed the validity period assigned by the manufacturer to the product.
b)    Accelerated Stability test must be made at a temperature of 40ªC +  2ªC and relative humidity of 85% + 5% or other conditions applicable to climatic zone IV during six (6) months. The conditions for pharmaceutical products requiring freezing storage shall be the following: temperature of 20ª+5ªC during non less than  (12) months. This tests guaranty a maximum of twenty four (24) months of validity for the commercialization of such products.
c)    The products based on stability tests made on a temperature of  30ªC+ 2ªC and relative humidity of 65% + 5%, must be transported and stored on dry storage areas, well ventilated with a temperature of 15 a 25 ªC.  This storage condition must be written on the label and primary package of the product (i.e. bottle).

• Finished Product Especifications:  physical, chemical and microbiological specifications.
• Analytical Standards (must be accompanied by its certificate of análisis, batch number, expiration date, and purity percentage.)
• Label in Spanish (it is not allowed to use stickers over the label)
  

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.