| REQUIREMENTS
FOR THE OBTAINMENT OF A HEALTH REGISTRATION FOR
PHARMACEUTICAL PRODUCTS, IN PANAMA
The
procedure for the obtainment of a Health Registration
of a pharmaceutical product is prosecuted before
the Pharmacy and Drugs Department of the Ministry
of Health.
The
requirements are the following:
A
Power of Attorney document (from
the proprietor of the product), duly notarized
and legalized by the Seal of the Apostille or
the Panamanian Consulate. Said Power of Attorney
must mention the name of the product to be registered
before our health authorities.
Certificate of Good Practice of the manufacturing
laboratory, issued by the competent authorities
of the country of origin, and duly legalized by
the Seal of the Apostille or the Panamanian Consulate.
Please be advised that according to our Health
Registration Law, said Certificate has a validity
of two (2) years counted as of its expedition
date, unless the document has another expiration
date.
Certificate of Pharmaceutical Product (CPP original)
duly issued by the competent authorities and legalized
by the Seal of the Apostille or the Panamanian
Consulate. Said document must not be on the letter
head of the company or manufacturing laboratory,
and must include the name of the product that
you desire to register. Please be advised that
according to our Health Registration Law, said
Certificate has a validity of two (2) years counted
as of its expedition date, unless the document
has another expiration date.
Quali-quantitative formula of the product, duly
signed in original by the responsible person of
the manufacturing laboratory.
Four (4) samples of the product as it will be
commercialized in our country, in each of its
variations, and must include, the name of the
manufacturing laboratory, the country of origin,
batch number, expiration date, pharmaceutical
form , way of administration, storage conditions.
Must include also the phrases “Keep out
of the reach of children” (Mantèngase
alejado de los niños) and “Sold under
prescription” (Venta bajo receta mèdica),
both in Spanish. Also the Certificate of Analysis
of said sample.
For your information, additional samples will
be requested by the Specialized Institute of Analysis
for the correspondent analysis, once the documentation
is filed before said Institution.
Four (4) original labels of the product or artwork
of the same. Must include also the phrases “Keep
out of the reach of children” (Mantèngase
alejado de los niños) and “Sold under
prescription” (Venta bajo receta mèdica),
in the primary and secondary labels, both in Spanish
language.
Finished product specifications.
Method of Analysis of the product.
Stability Studies of the product (final product)
from three (3) different batches, indicating the
validity period that it is being given to the
product, preferably a chart, with mention of the
temperatures, the type of recipient used on the
study, the duration of the study and the conclusion
of the same. Also, the studies have to be effectuated
at temperatures within the climatic zone IV, that
is, at 30°+2°C of temperature, and 70%+
relative humidity.
Literature of the product.
Information
as to the type of recipients used.
Information as to the interpretation of the batch
number.
Working standard of the product (a sample), clearly
identified with the name of the active ingredient,
the purity percentage, expiration date, batch
number and the storage conditions, with its correspondent
Certificate of Analysis.
Name of the distributer of the product in Panama.
With regards to the registration process, once
the documentation is received at our offices,
the same is sent to the Specialized Institute
of Analysis of the University of Panama to request
the calculation of the cost of the analysis to
be performed. Said analysis must be cancelled
before the application is submitted before the
Pharmacy and Drugs Department.
Once
the health registration application is submitted
to the Pharmacy and Drugs Department, said documentation
is examined by a Pharmaceutical Examiner, and
if said Examiner estimates that the technical
documentation complies with all the requirements
of our health authorities, they will order the
issuance of the correspondent Health Registration
Certificate. The analysis of the product will
be effectuated after the expedition of said Certificate.
The
timeframe of this procedure is approximately six
(6) months, since in the event that the Pharmacy
and Drugs Department requests some clarification
as to further documentation, said entity will
consent a period of 120 days to file said additional
documentation.
Please
be advised that the Health Registration Certificates
for medical products have a validity of five (5)
years, counted as of the expedition date, and
may be renewed for equal periods of time.
Expenses:
Analysis
of each product by the Specialized
Institute of Analysis |
US$750.00 |
1st
post registration analysis (due after the
product has been approved) |
US$750.00 |
2nd
post registration analysis (due after the
product has been approved) |
US$750.00 |
| Expedition
services for the Health Registration, by the
Pharmacy and Drugs Department |
US$200.00 |
| Fiscal
stamps affixed to the application |
US$4.00
p/page |
| Legalizations
and authentications before the Ministry of
Foreign Relations |
US$10.00
p/doc. |
| Certificate
of Registration |
US$14.00 |
| Registry
Right |
US$25.00 |
| Countersign
by a proper pharmacist |
US$30.00 |
| Countersign
by the National College of Pharmacists |
US$20.00 |
| Miscellaneous
|
US$25.00
approx. |
| |
|
| TOTAL
|
US$2578.00
approx. |
|
