The purpose of the Regulatory Impact Analysis Report is to ensure that, when preparing and approving a project, all the information necessary to estimate the impact that the standard will have on its recipients and agents is available.

The rules that form our legal system must be simple, their content must be easily understood by those to whom they are addressed.

El 27 de octubre de 2017 el Consejo de Ministros aprobó el Royal Decree 931/2017 regulating the Memory of Regulatory Impact Analysis and repealing the previous text of the year 2009. The new Royal Decree aims to develop the forecasts contained in the new wording given to Article 26.3 of the Law 50/1997 of 27 November 1997 of the Government by Ley 40/2015, de 1 de octubre, de Régimen Jurídico del Sector Público, regarding the Report of the Regulatory Impact Analysis that should accompany the draft laws and projects of Real Decrees, Real Decrees, Legislative Decrees and regulatory norms. It is thus adapted to the developments in the new administrative laws and to the recommendations and best practices of the OECD and the European Union. The text also includes a 6-month mandate for the adaptation of the current Methodological Guide for the elaboration of the MAIN.

The Regulatory Impact Analysis is a tool for improving regulation by systematizing and ordering important information to assess the impact of a regulatory initiative in order to assist in the approval process.

Marketing Authorisation Holder and Manufacturer Regulatory Impact Analysis Memory (MAIN) is the document that collects and unifies the information that accompanies a regulatory project, justifying its timeliness and necessity and making an estimation of the impact in different areas of the reality that will be approved.

In patients with chronic hepatitis C, MAIN indicate, with an estimate of their economic quantification, the administrative burdens introduced by the standard and/or which have been removed or reduced in relation to the previous regulation.