The Ministry of Health, through a circular addressed to holders of marketing authorisations for medical-surgical devices (presidi medico-chirurgici, PMCs), has provided guidance on the deadlines for submitting applications for changes to product composition that affect active substances, such as variations in the concentration or replacement of an active substance.
The guidance aims to clarify how the submission of such applications should be coordinated with the transitional regime established under Article 89 of Regulation (EU) No 528/2012, thereby reducing the risk of rejection or withdrawal of the marketing authorisation. It applies to PMCs falling within the scope of the Regulation and to variations affecting active substances. It does not apply to new marketing authorisation applications or to variations that do not affect active substances.
Deadline esestablished by the Ministry of Health
As a general rule, when determining whether a PMC has been supported for the purposes of its subsequent authorisation as a biocidal product, the authorised composition in place on the date of approval of the active substance is taken into consideration. A pending application for a variation does not, in itself, render the new composition effective.
The Ministry distinguishes between three scenarios, depending on how far in advance the application is submitted relative to the active substance approval date:
For cases in which the procedure may continue, the circular also establishes transitional periods for batches manufactured with the previous composition: up to 180 days for placing on the market and making available on the market, and up to 365 days for use, unless the new authorisation becomes applicable earlier.
The Ministry therefore recommends that PMC marketing authorisation holders plan their applications in accordance with the active substance approval date and verify that the composition specified in the application for biocidal product authorisation corresponds to the composition covered by the requested variation.
For further information, please refer to the relevant ministerial circular.
Bio Chem Srl supports companies in the regulatory management of medical-surgical devices (PMCs) and biocidal products, including the preparation and submission of the documentation required for composition variation applications and biocidal product authorisation applications.
Sources: Ministry of Health. "Guidance on the Appropriate Timing for Submitting Applications for Changes to the Composition (Active Substance) of Medical-Surgical Devices".