• Power of attorney granted by the manufacturer.  It must be legalized.
• Analytic Method.  If the manufacturer uses a pharmacopoeia method it will be enough to mention its name, edition and year.  On the contrary, it shall send the physical-chemical, microbiologic and pharmacological method.
• Analysis certificate:  It must include the following:
  

a)    Name of the responsible of the analysis.
b)    Name of the city and country where the manufacturer is located.  If the packing is carried out the other company the city and the country its location.
c)    The commercial name of the final product.
d)    The name of the active principles (International Common Denomination).
e)    Bath number of the sample (it must be the same batch sent to Panama for analysis)
f)    Manufacture date, analysis date, expiration date.
g)    Product description
h)    Tests made to the sample, according to the pharmaceutics form.
i)    The results.
j)    Bibliographic reference of the analytic method used.
k)    Minimum and maximum permissible
l)    Signature of the person responsible for the quality of the product.

• Certificate of Free Sale issued by the health authority of the country of manufacture or any other World Health Organization.  This document must include the following:

a)    The name and pharmaceutical form of the product.
b)    The name(s) of the active principles (DCI) and its concentration.
c)    It must be legalized.
d)    It must not have more than two years from issuance date.
e)    Commercial Name or Trademark and its variations.
f)    Manufacturers name and country of manufacturing.  If the product is made by a third party in a third country or if the product is packed in a third country it must include such company name and the country where it is located.
g)    That the product is free to be sold in the country of origin or that the product is currently on sale or is consumed in the country of origin

• Certificate of Good Practices of Manufacture granted by a health authority of the country of origin to the manufacturer.
• Clinic Studies (for new products, innovative products or others when required by the health authority).
• Label in Spanish (it is not allowed to use stickers over the label)
• Information regarding the packing material
• Bibliographic information of the product.
• Samples.  (Minimum 30 samples that must include the batch number and the expiration date)
• 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 required for first registration.  In cases where the product is sensitive to the conditions of zone IV, stability will be required for renewal.  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 65% + 5% or other conditions applicable to climatic zone IV. The conditions for refrigerated products will be 5% + 3% C of temperature. Four (4) measurement must be taken in the analysis during the first year, and every six (6) months the second year, and yearly for the following years until is completed the validity period assigned by the manufacturer to the product.
The maximum shelf life that can be granted will be five (5) years.
b)    Accelerated Stability test must be made at a temperature of 40ªC +  2ªC and relative humidity of 75% + 5% or other conditions applicable to climatic zone IV during six (6) months. The conditions for pharmaceutical products requiring refrigeration shall be the following: temperature of 25ª+2ªC and relative humidity of 70% + 5% during non less than six (6) months. The conditions for pharmaceutical products requiring freezing storage shall be the following: temperature of 20ª+5ªC during non less than twelve (12) months. This accelerated stability tests guaranty a maximum of twenty four (24) months of validity for the commercialization of such products. In these cases the manufacturer is engaged to file the real stability test for the approved period of time.  The sanctions typified in the Law will be applied for non compliance.
c)    The real stability test will be accepted for products sensible to the climatic zone IV.  This studies shall be made on a temperature of  25ªC+ 2ªC and relative humidity of 60% + 5%, if the product is to be used on hospitals or if there are no similar products available on the local market.  In this cases the manufacturer must prove that the quality of the product is substantially affected at a temperature of  30ªC+ 2ªC and relative humidity of 65% + 5%, and that there are no similar products on the market that showed stability under the previous conditions. In this case the authority will grant a maximum shelf life of 24 months  and the distributors are obliged not to sell the products at commercial places that do not meet the conditions for the proper storage of this kind of products.  The no compliance will be considered as serious offense.

Note:  For more information on the minimum content of the stability test please review the Executive Decree No.504 of November 9th, 2005 or contact your lawyer.

• Specifications for the finished product
• A sample of the active product (enclose analysis certificate with the batch number, manufacturers date, expiration date and concentration of the active)
  

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$750.00
• 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.