Secretariat

When a formulation and use profile of a product are similar to that of previously approved products i.e. within precedents, HSE can evaluate "in-house", without the need for consultation with external advisers. Whether the secretariat route is appropriate will be considered by HSE when we receive the application. The procedure for applying via the secretariat route is:

A completed application form and draft label should be submitted to HSE.

• HSE determines whether the secretariat route is appropriate, and invoices the appropriate fee. There may be occasions when an application falls outside of precedent but slight alteration, e.g. changing the application rate, will bring the application back into precedent. In such instances HSE will debate the possibilities with the applicant.
• On receipt of the fee, evaluation commences and at this stage further information may be requested e.g. specific packaging details or Safety Data Sheets for unknown ingredients.
• If data, previously submitted to HSE, is required to support this new application, but is still within data protection, then the applicant will need to request a letter of access from the owner of the data and include the letter of access in the application package. If a letter of access from the data owner cannot be obtained, then new data will have to be provided.

• Once all outstanding information is received and evaluated, a draft schedule is sent to the applicant for agreement. At this stage we request a copy of the draft label if one has not already been provided.
• Upon receipt of the applicant's agreement and once Ministerial consent is obtained, a Notice of Approval and final schedule is issued to the approval holder.