The health emergency triggered by the spread of COVID-19 has clearly highlighted the importance of disinfectant products, which from a regulatory point of view can be Surgical medical devices (PMC) or biocides depending on the active ingredient contained.
The companies that, in unsuspected times, had authorized products with virucidal, bactericidal, yeast-containing claims, etc. they had a commercial advantage over companies that had chosen the easier route of marketing sanitizing products.
Although there has been a concrete possibility of being able to enter a well-defined market thanks to the authorizations of biocidal products in derogation (now closed), companies find themselves having to make a choice in view of a possible second wave of the virus: to continue with the products sanitizers or take the path of disinfectants.
To have a disinfectant product on the market, the regulatory procedures are:
- Authorization for the production of medical surgical devices ( PMC ): the company is officially recognized by the Ministry of Health as production workshop of one or more PMCs in their own name or on behalf of third parties,
- Marketing authorization of PMC: a product, containing active substances under review, which for the activity it carries out and the mode of action falls within the definitions of Presidential Decree 392/1998 is authorized by the Ministry of Health,
- Authorization of a biocidal product: a product, containing approved active substances, which for the activity it carries out and the mode of action is authorized by the Ministry of Health pursuant to EU regulation no. 528/2012.
The list of active substances under review still has many items and the authorization of a production site as a PMC workshop will make sense until the review program is completed.
Companies wishing to produce PMCs in Italy must submit a specific request to the Ministry of Health providing information on the suitability of the plant to produce PMC and the presence of a technical director in possession of specific cultural and professional requirements.
The Ministry of Health issues the production authorization after inspection of the plant by the NAS. The authorized workshop may be subjected to further checks (follow-up inspections) to verify that the authorization requirements persist over time.
Workshops already authorized for one or more types of PMC and for one or more physical forms may request the extension of their authorization to other types and physical forms.
The types of PMC for which it is possible to authorize the workshop are:
1) Disinfectants and substances marketed as germicides and bactericides:
- a) for human use;
- b) for environmental use.
2) Insecticides for domestic and civil use.
3) Insect repellents:
- a) for human use;
- b) for environmental use.
4) Topicides and rat poisoning for domestic and civil use.
The physical forms are:
- Liquids (ranging from pure and solutions, to emulsions and foams),
- Semisolids (pastes, creams and gels),
- Solids (ranging from powders to baits and sticks).
The suitability of a workshop to produce a physical form (example: dry granules) implies the suitability to carry out all stages of production (quality control of raw materials, semi-finished, bulk, distribution and / or primary and secondary packaging , quality control on the finished product).
The production of PMC can also be carried out on behalf of companies that have authorized one or more PMCs, provided that the production site is mentioned among the production workshops in the product authorization decree.
Formal authorization from the ministry is not required for the production of biocides. Regulation 528/2012, however, establishes in Article 65 that […] manufacturers of biocidal products placed on the Union market shall keep, in relation to the manufacturing process, the documentation, in paper or electronic format, necessary for quality purposes safety of the biocidal product to be placed on the market and ensure that samples of production batches are kept. The documentation includes at least:
- a) the safety data sheets and the specifications of the active substances and other ingredients used in the manufacture of the biocidal product;
- b) the documentation of the various manufacturing operations carried out;
- c) the results of internal quality controls;
- d) identification of production batches. […].
The recognition of a production site as a PMC production workshop constitutes, for companies that request it, a step in professional growth and an opportunity to consolidate well-defined production procedures. In addition, in the historical period we are experiencing, it represents a commercial opportunity of advantage over other competitors.
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