Registry

Sanitary

Medicines


Requirements for registering drugs with the Department of Pharmacy and Drugs of the Ministry of Health (under this heading: topical anesthesia and sterilizing solution of medical instruments)


All documents must be issued on letterhead of the manufacturer laboratory duly signed by the person in charge.
Items 3 and 4 that must be issued by the Health Authority.

All documentation must be submitted in original and one (1) copy set.


Cosmetics


Requirements for the registration of cosmetics and cosmetics medicated before the Directorate of Pharmacy and Drugs of the Ministry of Health (enter this line: liquid soap and fluoride). Decree 178 of July 12, 2001


Foods


Requirements and procedures for sanitary registration of food before the Department of Food Protection of the Ministry of Health (DEPA)

All food products sold in the Republic of Panama must obtain a Food Sanitary Register, which is issued by the Department of Food of the Ministry of Health.


Agrochemicals


Requirements for the registration of agrochemicals for use in agriculture must be requested from the plant health department of the Ministry of Agricultural Development



TECHNICAL MATERIAL

The application shall be accompanied by the following documents:

  • Pre-evaluation agro-chemical-ecotoxicological, on pre-evaluation.
  • Label, according to the current regulation (2 copies).
  • Certificate of analysis that includes the complete qualitative and quantitative formula of the technical subject, detailing the generic and chemical name according to IUPAC of the active ingredient (s), as the inert (s), if there are .
  • True copy of the original of the letter (power), duly legalized and in force, issued by the manufacturer, where it authorizes the registration of the technical matter, including the legal domicile of the same.
  • Method of analysis of the technical matter (active ingredient and constituents).
  • Certificate of Free Sale, issued by the Competent National Authority in the country of origin (where the product is formulated), duly legalized and in force. If the product is produced only for export, because it has no commercial use in the country or is a restricted technical matter, the Competent National Authority must indicate the reasons and must be legalized.
  • Additional information including informational material.
  • In the case of the commercial register of a technical subject to formulate a pesticide, manufactured in the country, a certificate of operation of the manufacturer must be submitted, issued by the National Plant Protection Authority.

The application shall be accompanied by the following documents:

  • Pre-evaluation agro-chemical-ecotoxicological, on pre-evaluation.
  • Label, according to the current regulation (2 copies).
  • Certificate of analysis including the complete qualitative and quantitative formula of the technical matter for formulating a biological control agent or microbiological product, detailing the active agent (s), such as the inert agent (s) . The same must be signed and sealed by the technician responsible for the analysis of the quality of the technical matter.
  • A true copy of the original of the letter (power), duly legalized and in force, issued by the manufacturer, authorizing the registrant (natural or legal person) to carry out the commercial registration of the technical matter to formulate a control agent Biological, including the legal domicile of the same.
  • Method of analysis of the active ingredient of the biological control agent or microbiological product.
  • Certificate of Free Sale, issued by the Competent National Authority in the country of origin (where the product is formulated), duly legalized and in force. If the technical matter is produced only for export, because it has no commercial use in the country or is a restricted technical subject, the Competent National Authority must state the reasons and must be legalized.
  • Additional information including informational material.
  • In the case of the commercial register of a technical matter to formulate a biological control agent or microbiological product, manufactured in the country, a certificate of operation of the manufacturer must be submitted, issued by the National Plant Protection Authority.

The application shall be accompanied by the following documents:

  • Pre-evaluation agro-chemical-ecotoxicological, on pre-evaluation.
  • Certificate of analysis that includes the complete qualitative and quantitative formula of the additive, detailing the generic and chemical name according to IUPAC of the active ingredient (s), as the inert (s), if any.
  • True copy of the original of the letter (power), duly legalized and in force, issued by the manufacturer, where it authorizes the registration of the technical matter, including the legal domicile of the same.
  • Method of analysis of the technical matter (active ingredient and constituents).
  • Certificate of Free Sale, issued by the Competent National Authority in the country of origin (where the product is formulated), duly legalized and in force. If the technical matter is produced only for export, because it has no commercial use in the country or is a restricted technical subject, the Competent National Authority must state the reasons and must be legalized.
  • In the case of the commercial register of a technical matter to formulate a biological control agent or microbiological product, manufactured in the country, a certificate of operation of the manufacturer must be submitted, issued by the National Plant Protection Authority.

The application shall be accompanied by the following documents:

  • Pre-evaluation agro-chemical-ecotoxicological, on pre-evaluation.
  • Certificate of analysis that includes the complete qualitative and quantitative formula of the fertilizer or biofertilizer, detailing the generic and chemical name according to IUPAC of the active ingredient (s), such as the inert (s), If it existed.
  • True copy of the original of the letter (power), duly legalized and in force, issued by the manufacturer, where it authorizes the registration of the technical matter, including the legal domicile of the same.
  • Method of analysis of the technical matter (active ingredient and constituents).
  • Certificate of Free Sale, issued by the Competent National Authority in the country of origin (where fertilizer or bio-fertilizer is formulated), duly legalized. If the product is produced only for export, because it has no commercial use in the country or is a restricted additive, the Competent National Authority must indicate the reasons and must be legalized. This subsection only applies to bio-fertilizers.
  • In the case of the commercial register of a technical matter to formulate a fertilizer or bio-fertilizer, manufactured in the country, a certificate of operation of the manufacturer must be submitted, issued by the National Plant Protection Authority.

Regulatory provisions for the registration of agrochemicals

Law No. 47 of July 9, 1996 (6.0.23, 078/12/07/96) By which phytosanitary protection measures are issued and other provisions are adopted. Law of Plant Health.

Executive Decree No. 63 of 01/09/97 (6.0.23, 372 of 08/09/97) Regulates the Registration, application, activity and Service of Pesticides and Fertilizers for use in agriculture in Panama.

Resolved MIDA -023-ADM of 04/22/98 (6.0.N.23, 538 of 08/05/98) Establishes regulations and procedures for the registration, safe and effective use of fertilizers, technical materials and pesticides For use in agriculture in Panama.

Resolved MIDA N ° ALP-019-ADM-07 of 22/02/01 (GON 24, 330 of 25/06/01 and 24, 584 of 06/28/02) We are at your disposal to clarify any doubts as well as Provide cost information.