MINISTRY OF HEALTH

EXECUTIVE DECREE NO. 1195

(of December 3, 1992)

“Whereby the title of Chapter II and Articles 11, 41, 42, 43 and 44 are

amended and Articles 421a, 42b, 42c and 49a of Decree 256 of June 13,

1962 are added.”

THE PRESIDENT OF THE REPUBLIC

in exercise of his legal powers,

WHEREAS:

It is the obligation of the Government to look after the health of the

population;

It is necessary to update the rules concerning the Food and Beverage

Registration and Control, in order to expedite the procedures of such

registration and control and at the same time conform said rules to the new

technical criteria prevailing in the field;

Through the Ministry of Health, the Executive Branch must analyze and

solve any national problem affecti ng public health;

RESOLVED:

ARTICLE 1: The title of Chapter II and Article 11 of Decree No. 256 of

June 13, 1992 shall be as follows:

CHAPTER II

CONCERNING FRESH FOODS AND ITS BY -PRODUCTS

ARTICLE 11: For the purposes of these rules, fresh

food means such f ood sold without being modified at all as

coming from its natural source.

ARTICLE 2: Article 41 shall read as follows:

ARTICLE 41: All food and beverages that have

undergone any transformation or preservation process and

are sold canned, bottled or package d in any manner, under

 a given name and trademark, shall count with a Sanitary

Registration issued by the Food Control and Veterinary

Vigilance Department of the Ministry of Health for its

manufacture, import or free trade in the territory of the

Republic of Panama.

ARTICLE 3: Article 42 shall read as follows:

ARTICLE 42: To obtain the above mentioned Sanitary

Registration, natural or juridical persons must file through

an attorney an application written in stamped paper before

the Food Control and Veterina ry Vigilance Department of the

Ministry of Health, requesting the Registration of its

products and such application must indicate the name of the

product sought to be registered, the name of the

manufacturer and place of origin, description of the product

and the name of the product representative, agent and/or

distributor.

The interested party shall file the following documents

together with its application:

a. Power of attorney from the manufacturer or its agent,

representative or distributor. In the eve nt the power of

attorney is issued in a foreign country, it must be

authenticated before the Panamanian Consul at such place.

b. Free Sale Certificate of the foreign product, issued

by the health authorities or the competent authority in the

country of origin during the last six (6) months before the

application date, duly authenticated before the Panamanian

Consul at the place of issuance.

c. Plants manufacturing national products must file copy

of the valid Operation Permit issued by the health

authorities.
 d. Original and one copy of the quali -quantitative

formula of the product.

e. Description of the manufacturing process of the

product explaining the transformations suffered by the raw

material since the beginning of the process until the finished

product is obtained. This information must be filed in a

narrative manner or in form of a diagram, and must include

temperatures, pasteurization, cooling and freezing time, in

addition to the average life of the product.

f. Additional information relative t o the preservation

and biological stability of the product.

g. The production and expiration date clearly indicated

in the label of the product must be filed for foods having a

short average life or which need cooling or freezing for its

preservation.

h. Four (4) labels of the product, which shall comply

with the existing provisions.

i. One (1) facsimile of the product container together

with a description of its components.

j. Description of the lotting system.

Paragraph: Labels of products coming from abroad may be

in a foreign language but the representative of such product

in Panama must adhere to the container or bottle a

supplementary label in Spanish containing the Registration

number, contents of the product and instructions for use.

ARTICLE 4: Article 42a is added as follows:

ARTICLE 42a: Upon filing of the application, the Food

Control and Veterinary Vigilance Department shall determine

if same is accepted or rejected and shall notify this fact in

writing to the interested party. In the event th e application

 is rejected, the reasons therefor must be indicated.

Once the application is accepted and the interested party is

notified, it shall pay to the Food Control and Veterinary

Vigilance Department the cost of the analysis within fifteen

(15) days. If the interest party shall not pay the cost of said

analysis within the stipulated period of time, it shall be

assumed that the interested party has abandoned its

application and same shall be dismissed.

The Food Control and Veterinary Vigilance Depart ment shall

determine if the analysis is to be conducted by the Central

Health Laboratory of the Ministry of Health, the Specialized

Analysis Institute of the University of Panama or any other

laboratory pertaining to the Ministry of Health. Upon

payment of the analysis, the interested party shall deliver

the complete list of ingredients and the necessary amount of

facsimiles of the product to be analyzed, such amount being

determined by the Food Control and Veterinary Vigilance

Department.

ARTICLE 5: Article 42b is added as follows:

ARTICLE 42b: Incomplete documentation shall not be

processed and will be returned to the interested party,

indicating in writing the reasons for said return. If the

interested party rejects to receive the returned

documentation, such situation must be evidenced in a report

prepared and signed by the Secretary of the Food Control

and Veterinary Vigilance Department. Once this measure is

adopted, the application shall be taken as dismissed and will

be placed inactive.

The foregoing provision is applicable for the registration and

renewal procedures.
ARTICLE 6: Article 42c is added as follows:

ARTICLE 42c : If the analysis of the product shows a

satisfactory result, the Food Control and Veterinary

Vigilance Department shall grant t he pertinent Sanitary

Registration. Internal Revenue Stamps in the amount of

FOUR BALBOAS (B/.4.00) (legal currency of the Republic of

Panama) and the Retirement and Pension stamp shall be

affixed thereto, one of which shall be for the file copy.

The Food Control and Veterinary Vigilance Department

reserves the right to reject and consequently deny the

Registration of such products containing substances harmful

to health or whose analysis results are not satisfactory

pursuant to the existing provisions.

ARTICLE 7: Article 43 is added as follows:

ARTICLE 43: Once the Sanitary Registration has been

approved, the interested party shall pay the public treasury

as registration fee the amount of TWENTY -FIVE BALBOAS

(B/.25.00) if concerning a foreign product, and the amount of

TEN BALBOAS (B/.10.00) if concerning a national product.

ARTICLE 8: Article 44 shall be as follows:

ARTICLE 44: The Sanitary Registration shall be valid for

five (5) years as from the issuance date and same may be

renewed indefinitely for s imilar terms provided the

manufacturer, agent or distributor files the renewal

application within six (6) months before the expiration date

of the registration. If said application is not filed within this

period of time, the registration shall be automat ically

cancelled and, consequently, the manufacture, import or

sale of the product will not be permitted in the country until

the Registration is once again requested and obtained.

ARTICLE 9: Article 49a is added as follows:

ARTICLE 49a: Foods, food addit ives and containers for

food are subject to the food standards and methods set

forth in Codex Alimentarius.

ARTICLE 10: This Decree amends the title of Chapter II and Articles 11,

41, 42, 43 and 44 and adds Articles 42a, 42b, 42c, and 49a of Decree 256 of

June 13, 1967 and revokes all provisions contrary to it.

ARTICLE 11: This Decree shall entry into force as from the date it is

ennacted.

Done in the City of Panama, on the 3 r d day of the month of December, 1992.

BE IT NOTIFIED AND PUBLISHED.

(Sgd.) GUILLERMO ENDARA GALIMANY, President of the Republic

(Sgd.) GUILLERMO ROLLA PIMENTEL, Minister of Health