Advertising of Biocides and PMCs
The advertising of PMCs (Presidi Medico Chirurgici, medical surgical aids) is governed by Article 9 of Presidential Decree of 6 October 1998, no. 392. This article provides for that advertising with any text or image of the relevant product is subject to the 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, will provide for the revocation of the PMC marketing authorisation.
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 shall still comply with Regulation (EC) no. 1272/2008.
For PMCs, the company responsible for the marketing of a product shall apply for the authorisation to carry out healthcare advertising by submitting an application including all information pertaining the company, the advertised product, the type of advertising and the relevant medium.
Di Renzo Regulatory Affairs has a dedicated unit made up of regulatory experts in the field of biocides and PMCs (Presidi Medico-Chirurgici, medical surgical aids). We can therefore assist companies in all required activities, including:
- support in the application of the current PMC and biocide legislation.
In the case of PMCs:
- detailed examination of the company’s documentation prior to its submission to the Ministry of Health
- suggestions and amendments to the advertising message
- preparation of the application, submission to the Ministry and supervision of the whole administrative process.
Upon request, Di Renzo Regulatory Affairs can also handle all phases of graphic design and printing of advertising material.
