The Ministry of Health, Consumption and Social Welfare has published the Guide for the advertising of medicines for human use aimed at the public, issued by the General Directorate of Basic Portfolio of Services of the SNS and Pharmacy.

This second version of the guide is based on the new action criteria that regulate the advertising of non-prescription medicines addressed to the public, since RDL 1/2015 approving the revised text of the law on guarantees and rational use of medicines and health products in article 80.3 eliminates the Prior Health Control (PSC) by the Health Administration of this type of advertising.

The basic differences of this new version, in relation to the previous edition, can be summarized in:
– Change of title to “Guide to the advertising of medicinal products for human use to the general public”.
– The authorship has been based on the Agreement between MSCBS, anefp and Autocontrol.
– The definitions and principles of advertising, both general and specific, have been included in the same section.

– A classification, without the character of “numerus clausus”, of advertising supports has been incorporated, grouping them according to the means of communication to which they belong.
– Elimination of the section “Prior administrative authorisation” as there is no SPC.
– New specifications are introduced according to “Supports” or “Pieces” advertising, especially with regard to television sponsorships, accessibility for people with disabilities and specifications for digital supports.
– In the “Code of Good Practice (…)” the criteria related to the type of medium have been eliminated and interpretative criteria for the standard have been updated.
– All the documentation models related to SPC have been eliminated from Annex I, leaving only the “Annual Activity Model”.
– The “Bibliography” section has been removed from Annex II.

Resolve your doubts sending an email to our partner   Cristina Simon  : cristina.simon@tc-abogados.com.

Thomás de Carranza Abogados provides legal services in the field of advertisement and consumer goods. In particular in:

» Advertisement contracts.

» Procedures with advertisement self-regulation bodies.

» Proceedings in civil and administrative courts.

» Labelling, responsibility and warranty of consumer goods.

» Distance-sales, electronic trade and contracting, etc.