COVID-19 Emergency: on 7 October 2020, the Ministry of Health, through the Directorate General for Medical Devices and Pharmaceutical Services, issued a new decree
Considering the resumption of in-person school activities and related services, which will lead to an increased demand for disinfectants for human and environmental hygiene, as well as the evolution of the national epidemiological situation and that of neighboring countries, the Directorate General for Medical Devices and Pharmaceutical Services has issued a new decree.
TEAM mastery, leveraging its extensive knowledge acquired over many years of work in the field of PMC and Biocides, aims once again to support companies involved in disinfection by identifying the correct authorization path and implementing all regulatory procedures necessary for proper product placement on the market.
At this specific time, when the management of the COVID-19 emergency in terms of disinfection and prevention has become a priority again, the Italian Competent Authority is once more offering several paths to support the maintenance on the market of previously authorized products under derogation pursuant to Art. 55 paragraph 1 of Regulation (EU) No. 528/2012 and to facilitate the placing on the market of new products with proven disinfectant (particularly virucidal) activity in order to effectively contain the spread of the virus.
Specifically:
– Based on Article 1 of the decree, the authorizations granted under Article 55, paragraph 1 of Regulation (EU) No. 528/2012 are renewed for a period of 180 days from the expiry date of the first authorization decree.
The previously indicated sales and labeling conditions remain unchanged.
– Article 2 announces the reopening of the deadline for submitting new derogation authorization requests under Article 55 paragraph 1 of Regulation (EU) No. 528/2012 for a period of 15 days from the publication of the aforementioned decree. The submission of applications must be accompanied by a series of supporting documents (listed in Annex I to the decree).
– Article 3 states that disinfectant formulations with a composition identical to that recommended by the WHO are considered tacitly approved after 15 days from the submission of a declaration attached to the decree, for a maximum period of 180 days from the date of approval. Those who have already submitted such a declaration by 15 July will only need to send a declaration (Annex IV to the decree). These products will also be considered tacitly approved after 15 days from the submission of the declaration.
The documentation must be submitted within 15 days from the publication date of this decree.
For those interested in receiving support in submitting new applications, feel free to contact us by email at the following addresses:
Managing Director: monicalocatelli@team-mastery.eu
Regulatory Affairs Specialist on Biocides: stefanotortelli@team-mastery.eu