·   Active Drug registration

(1) As an active substance applying for registration for the first time, the applicant first determines the evaluation Member State (RMS) to submit the dossier;

(2) The RMS shall carry out the evaluation and issue a draft evaluation report for transmission to EFSA, the European Commission and other Member States of the European Union, and EFSA shall organize a public evaluation of the draft evaluation;

(3) The results of the assessment may be adopted by consensus of all member States.

·   Registration of preparations

(1) When applying for registration of a pharmaceutical product, the original drug used in the product must be approved by the European Union, and the applicant shall submit a dossier to the assessment Member State (RMS);

(2) The Evaluation Member (RMS) will send the dossier, the evaluation draft and the evaluation decision to all other Member States in the same region for review;

(3) Once the product has been authorized by a Member State, it can enter the market of other Member States in the same region by applying for regional mutual recognition.

Technical Equivalence assessment (Technical Equivalence) has a short cycle and low cost, and is the fastest registration method for pesticide companies to enter the EU market.

Pesticide manufacturers inside and outside the EU

Authorisation of pharmaceutical products is at the Member State level, and product marketing requires authorisation in all target countries.

In order to reduce the duplication of evaluation work and shorten the time for products to be placed on the EU market, the EU PPP regulation introduces a regional evaluation system and adopts a regional evaluation system for product registration. According to the relevant provisions of the regional assessment, the EU region is divided into three regions according to the agricultural climate conditions, North, central and south, and the regional unified assessment of the core dossier is implemented. In addition to the core dossier, the relevant Member State may have its own additional data requirements (such as efficacy, residues, environmental regression, etc.), and additional data related to national agricultural environmental conditions are included in the Member State dossier and are reviewed individually by each member State. For pesticide products applied that are not affected by agro-climatic conditions, such as those for indoor use (postharvest treatment, greenhouses, warehouses) and seed treatment, the whole of the EU is assessed as a region when the formulation is registered.

Zhongbang has successfully helped enterprises complete nearly 200 EU TE applications, involving more than 100 products. After more than 10 years of compliance experience, the team has a very rich and mature official channel resources, and has submitted applications in more than a dozen countries in the EU and successfully passed.

The team engaged in pesticide risk assessment research earlier in China; Master pesticide risk assessment techniques in Europe, America, China and other countries; Help enterprises to complete the regulatory requirements of the pesticide registration risk assessment; Carry out risk assessment at the trial stage to help enterprises reduce unnecessary tests and arrange high-level tests in a timely manner.

• New Active Substance registration

• EU Equivalence assessment of active drugs

• Application for Reassessment of Active substances

• Pesticide product Authorization