| REQUIREMENTS
FOR THE OBTAINMENT OF A HEALTH REGISTRATION FOR
COSMETIC PRODUCTS, IN PANAMA
The
procedure for the obtainment of a Health Registration
of a cosmetic product is prosecuted before the
Pharmacy and Drugs Department of the Ministry
of Health.
Requirements:
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 products to be registered,
including all variations.
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 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 expedition date.
Quali-quantitative formula in case of medicated
products, duly signed by the responsible person
of the manufacturing laboratory. For cosmetics,
it is only required the qualitative formula, duly
signed by the responsible person of the manufacturing
laboratory. For cosmetics containing restricted
substances, said concentration must be included,
as well as the name; the name of every ingredient
must be mentioned on the formula, according to
the International Nomenclature for Cosmetic Ingredients
(INCI); must mention the name of the product as
well as its variations; if the product has various
shades or varieties, it must be specified the
names and the numbers of the colors according
to the International Color Index. In case of aerosols
it must be mentioned the name and concentration
of the propellant gases, which shall comply with
our Legislations as to the protection of the ozone
layer.
Two (2) samples of the product as it will be commercialized
in our country, in each of its variations, and
must include, the name of the product, content
in weight or volume, name of the manufacturing
laboratory, the country of origin, batch number,
expiration date, storage conditions. Additionally,
and depending on the case, must also include the
precautionary legends in Spanish language.
Two (2) original labels of the product or artwork
of the same, including the information mentioned
above.
7.Finished product specifications, that is, microbiological
and physicochemical specifications.
Studies of the product if the same contains substances
of biological origin, vitamins, or substances
of easy decomposition, to support the products
shell life.
Documentation to support the qualities of the
product, in case the same is “hypo-allergic”,
“non-irritant”, “water-resistant”,
among others.
10.Name of the distributer of the product in Panama.
As a matter of information, please be advised
that it is possible to group in a single application,
up to ten (10) variations, in relation to the
characteristics of scent, color, flavor or concentration,
if they are manufactured by the same laboratory,
in the same country, and maintain the same pharmaceutical
form, use and principal components.
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
before 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
estimated timeframe for the above procedure is
approximately two (2) months, as long as the documentation
filed is complete and complies with our Law requirements.
On the contrary, if the Pharmacy and Drugs Department
requests some clarification as to further documentation
or information, said entity will consent a period
of 90 days to file said additional documentation.
Please be advised that the Health Registration
Certificates for cosmetic products have a validity
of ten (10) years, counted as of the expedition
date, and may be renewed for equal periods of
time.
Fees and Expenses:
Our
fees for preparing, filing and prosecuting the
health registration petition (each application),
are US$300.00.
Additionally,
the expenses to be incurred are the following:
Analysis
of each product by the Specialized
Institute of Analysis |
US$225.00
approx. |
Expedition
services for the Health Registration,
by the Pharmacy and Drugs Department |
US$200.00
each |
| Fiscal
stamps affixed to the application |
US$4.00
p/page |
Legalizations
and authentications before the
Ministry of Foreign Relations |
US$10.00
each |
| Certificate
of Registration |
US$14.00
each |
| Registry
Right |
US$25.00
each |
| Countersign
by a proper pharmacist |
US$30.00
each |
| Countersign
by the National College of Pharmacists |
US$20.00
each |
| Miscellaneous
|
US$25.00
approx. |
| |
|
| TOTAL
|
US$553.00
approx. |
|
