We often hear the "three certificates" of pesticides in pesticide products. One of the most important certificates is the "registration certificate number of pesticides". This pesticide registration certificate number is a very confusing thing, this certificate is like a "quasi-biological certificate", with it, pesticide products may be born, no, it is fake and inferior products, regardless of your actual test results. So today we'll take a look at the application for the pesticide registration certificate.
Pesticide Registration Certificate
Pesticide registration certificate is one of the necessary certificates for pesticide to enter the market and sell. The products with pesticide registration certificate show that the product has passed the examination and approval of pesticide registration authorities in the aspects of pharmacodynamics, toxicity, residues, environment and so on. It is in line with the market entry of pesticide diseases, insect pests, rodents or vector organisms. Conditions for prevention and control.
The Pesticide Inspection Institute of the Ministry of Agriculture and Rural Areas undertakes the specific work of the national pesticide registration and management entrusted by the Ministry of Agriculture and Rural Areas. Its main responsibilities are: responsible for pesticide registration and management, pesticide quality detection, pesticide biological determination, pesticide residue monitoring, pesticide market supervision, pesticide information exchange and external cooperation and services.
Classification of Pesticide Registration Certificates
Pesticide registration certificates are divided into official registration certificates and temporary registration certificates.
The format of pesticide registration certificate number is: product category code + year number + sequence number. The product category code is PD, and the product category code of sanitary pesticides is WP. The year number is the year when the pesticide registration certificate was issued, which is expressed in four Arabic numerals. The sequence number is represented by four digits of Arabic numerals.
· For pesticides used in the field, the temporary registration certificate number is marked with "LS", and the temporary health registration is marked with "WL", such as WL20060315; such as LS20071573; (after the implementation of the new Pesticide Management Regulations in 2017, the temporary registration certificate will not be approved again)
· The official registration certificate number is marked by "PD", such as PD20080005;
· For sanitary pesticides, the official registration certificate number is marked by "WP", such as WP20070316.
The types of documents are as follows:
· PD2010 ** is the official pesticide registration certificate of Datian, which was obtained in 2010.
· WP2010**** is the official registration certificate of pesticides for health, which was obtained in 2010.
A registration certificate with the letter "F" indicates that the product is a registration certificate for sub-packed pesticides.
Official Registration Certificate: valid for 5 years, renewable. Nowadays, many pesticide ingredients have entered the second evaluation. There are many supplementary materials. Whether the certificates are kept or not may be a problem to be considered. At a certain stage, the certificates are no longer advantages, but may be a kind of cumbersome.
Classification of Pesticides in Pesticide Registration
New pesticides refer to pesticides containing active ingredients that have not yet been approved for registration in China, including new pesticide original drugs (parent drugs) and new pesticide preparations.
Within six years from the date of registration of new pesticides, other applicants shall apply for registration according to the data they have obtained or authorized by the holder of the new pesticide registration certificate. (equivalent to six years of protection)
Birth process of certificate
The starting point is in the market department, taking a compound preparation as an example.
Firstly, determine which two components combination, determine the approximate proportion and dosage form, then determine the registered crops and control objects, and finally estimate the approximate dosage. It can be said that this time has entered the product project, the test of the market department's ability to predict, must not see how others, I also do, according to the gourd painting ladle.
After moulding, it is handed over to R&D department for preliminary test of pharmaceutical formulation, whether there are technical difficulties and feasibility. If the technology is difficult, can we change the dosage form or change the proportion to solve it?
After the preliminary formation, it is then handed over to the Department that declares the certificate to enter the certificate declaration procedure, which is the real entry into the certificate declaration process. It takes about two years from the beginning of the declaration to the end when everything goes smoothly.
Registration fees
At present, the cost of an environment is at least 800,000; the cost of a pharmacodynamic test is at least 300,000, five years, ten places a year; the residual cost is at least 500,000-600,000, and the cost of holding a new certificate is at least 1.8 million. If a new ingredient is quoted, the cost will be in the tens of millions.
"If a child is born, it depends on the sales department if it can support him or her." This phrase is often used by registrars. The meaning behind it is very clear. When setting up a project, we must be careful, and we must have a certain forecast of the changes in the market. At present, the cost of certificate is millions or even higher from hundreds of thousands to millions. The cost is real gold and silver. A certificate should bring profits. It should not end up as an embarrassing situation where the sales profit and the cost of certificate can not be earned back.
Note: The extension of the pesticide registration certificate reads as follows: "According to Article 40 of the Measures for the Administration of Pesticide Registration, if the production license has not been obtained as of August 1, 2019, this registration certificate will be cancelled."
On August 1, 2019, the enterprise has not yet obtained a production license, can not produce the original drug A, nor can it commission the processing of the original drug A. The certificate should be cancelled.