The advertising of Presidi Medico Chirurgici (PMC) is governed by Article 9 of the Decree of the President of the Republic of October 6, 1998, n. 392. This article stipulates that advertising with any text or image of the product is subject to authorisation from the Ministry of Health. In the event of non-conformity the Ministry will give formal notice to the company and, in severe cases, provide for the revocation of the marketing authorisation of the product.
The advertising of biocidal products is regulated by art. 72 of Regulation (EU) No. 528/2012, under which any advertisement must be accompanied by the sentences “Use biocides safely. Always read the label and product information before use” and must still comply with the Regulation (EC) no. 1272/2008.
For PMC the manufacturer or the company responsible for the marketing of a product requests authorisation to carry out healthcare advertising by submitting an application with full stamp duty, containing all information pertaining to the company itself, the advertised product, the type of advertising and its means of communication.
Di Renzo Regulatory Affairs offers advice for:
- The application of existing legislation
- Detailed examination of the documentation from the company prior to its submission to the Ministry of Health
- Suggested indications and eventual changes to the advertising message
- Preparation of the application, submission to the Ministry and supervision of the entire bureaucratic process
Upon request, Di Renzo Regulatory Affairs is also able to handle all phases of graphic design and printing of advertising material.