Requirements for the Sanitary Registration: Steps, Cost and MORE

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This article will explain all the Requirements for the Sanitary Registration in Peru. This document is important, because it authorizes citizens and legal entities to prepare, package and distribute products intended for the acquisition of citizens.

According to Article 104 of the Regulation on Food Sanitary Surveillance and Control highlights that said Sanitary Registry is established for products that have the same composition that identifies the group.

People who want to set up an establishment of products, should take their precautions to process this document that is essential in the Peruvian territory. Therefore, if you are interested in knowing more about this topic, we invite you to continue reading.

What are the Requirements for the Sanitary Registration?

Citizens who aspire to open an establishment must comply with the Requirements for the Sanitary Registration in Peru, are the following:

  • Citizens who have establishments must register with the Sanitary Registry of Foods for Human Consumption.
  • They must have the unique request of Foreign trade (It happens), you can get it in the next link. In the event that you do not have the Suce number, you have to manage it through your Bank Payment Code (CPB). Said request has the condition of an Affidavit that attaches the following information:

Sworn declaration

  1. Highlight your identification with your data or company name, address and the number of the Sole Taxpayer Registry of the natural or legal person requesting the registration or re-registration.
  2. Name showing the true nature of the articles and the brand that determines it.
  3. Highlight the name or company name, address and the nation of the places of production.
  4. To obtain the Sanitary Registry you must show the results of physical-chemical and microbiological analyzes of the finished product, submitted by the factory quality control laboratory or by a laboratory demonstrated by the INACAL as the laboratory demonstrated by the GCG.
  5. Show the result of bromatological analysis and is sent by the accredited laboratory through the National Institute of Quality (INACAL).
  6. The description of the ingredients and the proportional structure of the additives, specifying the latter by their common name and their international numerical relationship (SIN code).
  7. Said declaration must highlight the conditions of conservation and storage.
  8. Highlight the detailed information of the containers used, specifying the type, material and presentation.
  9. Develop the shelf life of the product under normal conditions of conservation and storage.
  10. Identification system production batch.
  11. Labeling project, governed by the rules of this regulation.
  • Following the Requirements mentioned in the previous bullet, citizens must present the document of Free Marketing or a Certificate of use sent through the authorities that make up the country of the manufacturer or the exporter, if the items are imported.
  • They must also be Re-registered in the Sanitary Registry of Foods for human consumption. Where you must do the following:
  1. Make the Single Application for Foreign Trade (SUCE), to have the SUCE number you will have to manage it with its respective Bank Payment Code (CPB), said request takes effect through an affidavit.
  2. Said the Affidavit follows the conditions for which the registration was granted and remain in force.

Steps to Follow to Obtain the Sanitary Registry

It is important to note that if people make products and want to market them in establishments such as wineries, supermarkets or some sales channel, they should know that said product must have a Sanitary Registry. For this reason, to process it, you must follow the following steps:

  • You must first have a Ruc number, which can be processed through the agency Sunat.
  • Then the National Health Directorate asks the person to have a draft label of the product which he is going to manufacture or has prepared.
  • Also said Directorate requests a physicochemical and microbiological examination of the product you have already made. This analysis can be obtained in a laboratory accredited by the National Institute of Quality.
  • This Sanitary Registry will be processed through the one-stop shop of the Foreign Trade at DIGESA.
  • Once they have their Ruc, with the analysis of the physicochemical and microbiological examinations. In addition to the label project, they must enter the Vuce page, then they must enter the Vuce system and click on «restricted merchandise».

Second part

  • Next you must put your Ruc and his password, once you enter you must select the option Suce and apply to the button «new request», where you must request the entity where you are going to process the Health Register.
  • After that you should look for the tab enrollment and re-enrollment of the Sanitary Registry of Foods for Mass Consumption.
  • A new tab will appear where you should select the type of procedureFor example, if you are starting to produce products, you must state that the procedure is for the first time. If you are already registered and want to re-register, give the second option.
  • Then you must save the form and a new window will appear. In this window, in the applicant’s data you must complete putting your name, surname, the Ruc, address, telephone, mail, etc.. Then it goes to the manufacturing establishments tab where you must complete the information where you must save it to continue with the process.
  • At the end of this window, you must go to the tab Products and / or Product Group. There you will highlight what your product to be made, what ingredients it has, among other things that you must complete and save.
  • Then you must give the last window which are the Attached Requirements, a window will appear which must upload both the physicochemical and microbiological analysis, the format which will give that analysis must be scanned and converted in pdf format. When you already have it in that format, you just have to attach it, just like the label project.
  • Once you have attached the documents, you will will arrive in the mailbox. an email in which your request is being processed, but before that you must make the payment that must be deposited in the bank.
  • When you have already deposited, you will receive another email explaining that the process is in process.

Cost of the Sanitary Registry

The cost depends on the following information:

  1. NO MYPE is approximately 241.50 soles (07% UIT).
  2. MYPE is from 69.00 soles (02% UIT). Where to attach the Affidavit that should highlight if it is a micro or small business.

Who Issues the Sanitary Registry?

The Sanitary Registry is sent through the Ministry of Health. Within this ministry there are two of its units which are: The General Directorate of Medicines, Supplies and Drugs (DIGEMID), as well as the General Directorate of Environmental Health (DIGESA).

How long does the process take?

The process of the Sanitary Registry may take at least less 7 business days. There are cases of people who have received it in 5 days.


What is it?

The Sanitary Registry is an authorization that is granted to the product that is going to be manufactured for its commercialization throughout the Peruvian territory for mass consumption.

Companies or people who do not have this document that confirms that food and / or does not harm can cause them to lose great opportunities in the business.

Certificate validity

It is important to note that the validity of this certificate is at least 5 years, counted from the date on which it was granted.

Products that do not need the Certificate

The Ministry of Health through the General Directorate of Medicines, Supplies and Drugs (DIGEMID) constantly through their website they publish a list of products that do not need the Sanitary Registry to be distributed throughout the national territory, whether they are national products or in any case they come from abroad. That is why the following products are mentioned:

  • Handpiece oil.
  • Printer accessories.
  • Instruments to perform exercises such as: weights, tables, dumbbells and discs.
  • Thermoplastic or modeling accessories for exclusive use in dental laboratories.
  • Acrylics to manufacture polymer braces (powder) with a variety of colors for exclusive use in dental laboratories.
  • Acrylics to manufacture orthotics in monomer (liquid) tinted with a variety of colors for exclusive use in dental laboratories.
  • Tri-distilled water for laboratory use.
  • Ethylene oxide aerators.
  • Wires as an input for exclusive use in dental laboratories.
  • Pliers of different shapes and sizes for the manufacture of orthopedic equipment for exclusive use in dental laboratories.

If you want to view the complete list of the names of the products that the DIGEMID disseminates, you can enter the following link.

VUCE

It is a system where it allows by electronic means to change the information provided for the entry, exit or circulation of goods and means of transport throughout the Peruvian territory.

Also with this system it helps people to carry out the procedures related to foreign trade that are managed by said page.

The VUCE It provides users with the necessary security through the provision of information related to the compromised parties.

If you want to manufacture and distribute products, you must take into account that you must comply with the Requirements for the Sanitary Registry What are you waiting for? Get organized and complete the procedures in time.

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