Medical Devices & Consumer Health Products 2021

Last Updated August 31, 2021

Italy

Law and Practice

Authors



Avvocati Associati Franzosi Dal Negro Setti is a member of the European network Conférence Bleue, which since 1997 has united leading firms in the pharmaceutical, health and medical fields, ensuring efficient delivery of highly specialised legal services on a multi-jurisdictional level. The firm's life sciences team offers assistance and consulting services in all aspects concerning research, manufacturing, commercialisation and use of medical products and veterinary products, medical devices, special foods and cosmetics. Representation in litigation is carried out before all competent authorities: ordinary civil courts, specialised IP divisions, administrative courts and European courts. The team also acts for clients in arbitration and proceedings before independent authorities or self-regulatory bodies, such as the Institute of Advertising Self-Regulation (IAP), and assists clients in out-of-court cases concerning regulatory aspects of pharmaceutical marketing authorisation with reference to issuance, maintaining, review and protection. Furthermore, it offers assistance and consulting services on price negotiation systems and classification of drugs for reimbursement by the Italian National Health Service.

Medical Devices

EU Regulations 2017/745 on Medical Devices and Active Implantable Medical Devices (MDR) and 2017/746 on in vitro medical devices (IVDR) introduce safety and vigilance obligations similar to those for pharmaceuticals.

Due to COVID-19, application of the MDR – initially planned for 26 May 2020 – was postponed to 26 May 2021, while IVDR will be applied starting on 26 May 2022; until then Directive 98/79/EC and Legislative Decree 332/2000 transposing it in the Italian system will continue to apply.

MDR reinforces safety standards of medical devices. Compared to the previous Italian legal framework (ie, Legislative Decree 47/96), different classes of risks are introduced with different pre-marketing steps/approval processes. A new traceability system is introduced with the so-called Unique Device Identifier code (UDI).

The Regulations introduce a new European database of medical devices (EUDAMED) that, when in force, will help to share on a single platform all information related to such devices marketed in Europe.

Pharmaceuticals

Legislative Decree 219/2006 (Medicinal Product Code) provides that medicinal products cannot be placed on the market without an authorisation from the Italian Drug Agency (AIFA) or an EU authorisation from the European Medicine Agency (EMA) in accordance with the EU Regulation 726/2004.

No one can manufacture medicinal products on the Italian territory without a manufacturing authorisation from the AIFA, issued after an inspection.

The pharmacovigilance "responsible person" must meet certain professional requirements and comply with obligations such as submission of periodic reports on product safety (PSURs).

PSURs are not required for generic, homeopathic, traditional herbal medicinal products or products based on substances which have a well-established medicinal use.

Blood Products

Industrial blood products are medicines produced through industrial manufacturing processes from human blood or plasma derived from voluntary donations.

Blood products must obtain a marketing authorisation as per Legislative Decree 219/2006 pursuant to assessment of quality, safety and efficacy.

Legislative Decree 219/2005 sets out basic rules for the national production of blood products.

Personal Protection Equipment

Personal Protection Equipment (PPE) are designed to be worn or held by an individual for protection against safety hazards. PPE must comply with requirements provided under EU Regulation 425/2016 (PPE Regulation). All PPE must meet Essential Health and Safety Requirements (EHSR) described in Annex II to PPE Regulation, and must be CE marked.

PPE are classified into three risk categories (Annex I):

  • Category I – PPE placed on the market by the manufacturer with an EU Declaration of Conformity;
  • Categories II and III – PPE pre-evaluated by a notified body that must issue a Certificate of Conformity.

Medical Instruments

Medical instruments are a broad category that include surgery instruments, ER instruments, invasive, non-invasive medical diagnostics instruments and, in general, all those instruments used in a medical environment to diagnose, cure, treat prevent diseases or help/support such purposes – for example, stethoscopes, endoscopes, polygraphs, electrocardiographs and syringes.

The intended purpose helps in determining whether a medical instrument is considered a medical device or not. If the instrument has been manufactured to be used for one of the medical purposes listed in Article 2(1) MDR or Article 2(2) of IVDR, then it is a medical device.

Cosmetics

EU Regulation 1223/2009 concerns cosmetic products. Its basic principle is that, to ensure the safety of cosmetic products, a “responsible person” must be designated within the EU to place the products on the market. Such responsible person is usually the manufacturer or a person designated in writing by the manufacturer acting on its behalf.

For cosmetics imported into EU, the importer is considered the responsible person. The distributor can also be considered the responsible person in specific cases.

For cosmetics placed on the market, the responsible person ensures compliance with the Regulation, and is responsible for, amongst others:

  • safety;
  • compliance with good manufacturing practices (GMPs);
  • traceability (also required of distributors, based on the principle of “one step back, one step forward”);
  • notification to the Cosmetic Products Notification Portal (CPNP) of the EU Commission prior to placing the product on the market;
  • labelling requirements;
  • communicating serious undesirable effects and information on substances to the competent authority.

Biocides

EU Regulation 528/2012 concerns the making available on the market and use of biocidal products (Biocidal Products Regulation, BPR).

Biocidal products cannot be placed on the market or used without authorisation pursuant to the BPR. National authorisation, a European centralised authorisation (for certain types of biocides) or a mutual recognition procedure (in sequence or in parallel) are available.

Active substances of a biocidal product must also be pre-approved.

Transitioning to full implementation of BPR, in Italy products containing active substances currently under review in accordance with BPR requirements can be placed on the market as per Presidential Decree 392/1998 as “Presidi medico-chirurgici” by submitting an application for a marketing authorisation to the Ministry of Health and National Institute of Health (ISS).

Food and Nutrition Supplements

Regulation 178/2002 reinforces the rules on safety of food in the EU. The basic principle is that no food dangerous to health or unfit for consumption may be put on sale in the EU.

EU Regulation 1169/2011 establishes general principles, requirements and responsibilities governing food information and labelling.

Mandatory food information falls into the following categories:

  • identity and composition, properties, and other characteristics of food;
  • protection of consumers’ health and safe use of a food;
  • nutritional characteristics.

Legislative Decree 231 of 15 December 2017 provides sanctions with respect to violations of EU Regulation 1169/2011.

EU Regulation 625/2017 sets common rules for official controls to ensure that agricultural food chain legislation to protect human health, animal health and welfare and plant health is correctly applied and enforced.

EU Directive 46/2002 concerns food supplements. With respect to safety of food supplements, the Directive provides a harmonised list of vitamins and minerals that may be added for nutritional purposes in food supplements. EU Directive 46/2002 has been implemented in Italy with Legislative Decree 169/2004.

The commercialisation of food supplements in Italy is subject to a label notification procedure to the Ministry of Health.

Medical Apps

Mobile applications are often used in connection with so-called “wearable devices”. Some of those apps, such as health, lifestyle, and general well-being apps, fall under the category of “mobile health” or “mHealth”.

Some of these mHealth apps may qualify as medical devices and will have to be CE marked and follow Medical Device Regulation 2017/7451 (MDR), fully applicable from 26 May 2021.

To determine whether an mHealth app is a medical device, the fact that an app for generic purposes is used in a health-related field is not sufficient. In general, apps that perform an action limited to storage, archival, communication, simple search (ie, simply matching metadata to search criteria – so-called library functions) are not considered medical devices. On the contrary, the discriminant is the “intended purpose”, whether the app has been intended by the developer to be used for one of medical purposes listed in MDR. In such a case, the mHealth app is considered a medical device.

“MEDDEV 2.1/6 Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices”, issued by the EU Commission in July 2016, and the “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”, issued in October 2019 by the Medical Device Coordination Group (MDCG), provide indications on the classification of risk class applicable to software and apps based on their characteristics and interactions.

Telemedicine

There are currently no specific laws on telemedicine in Italy. However, on 17 December 2020 "National Guidelines for the provision of telemedicine services" ("Guidelines") was approved by the State-Regions Conference. The Guidelines represent, so far, the reference document for implementation of telemedicine services under the National Healthcare System.

The Guidelines list the services that can be provided through telemedicine, taking also into account cybersecurity profiles and patients' consent (or the consent of their caregivers).

Wearables

Wearable electronic devices (“wearables”) are meant to interact and be worn in contact with the human body. They are part of the broader category of wearables.

Wearables are part of the Internet of Things (IoT), and are usually connected wirelessly with other devices (smartphones, tablets, laptops, smart TVs, etc). The popularity of wearables is due to their use for fitness and well-being purposes (eg, smartwatches or fitness bands measuring the number of daily steps or daily calories burned).

Whether a wearable is a medical device or not depends on the “intended purpose”, whether it has been intended by the manufacturer to be used for one of the medical purposes listed in Article 2(1) MDR or Article 2(2) of IVDR. If this is the case then the wearable is a medical device and is subject to regulatory approvals, safety requirements and post-market surveillance requirements set forth therein.

CBD (Cannabidiol)

The Decree of President of the Republic 309/1990, “Consolidated text of the laws on the regulation of narcotic drugs and psychotropic substances, prevention, treatment and rehabilitation of the related drug addiction states” (the Narcotic and Psychotropic Drugs Code) is the reference law concerning CBD.

Narcotic or psychotropic substances are subject to the supervision and control of the Ministry of Health.

Cannabis use is allowed for therapeutic purposes upon non-repeatable prescription and taking into consideration the specific condition of the patient.

Borderline Products

“Borderline products” are those not easily classifiable since they can be confused with other classes of products. Some products may incorporate characteristics, form and substances common to different products such as medicinal products, medical devices, cosmetics, food supplements, personal protection equipment, etc.

Typical borderline products are devices and medicinal products whereby a device contains a substance which, if used separately, would be classified as medicinal product.

To be a medical device a product must fulfil the definition given by EU Regulation 2017/745 on Medical Devices and Active Implantable Medical Devices (MDR), which provides two main elements to consider a product as a medical device:

  • the specific medical purpose; and
  • the principal intended action.

The specific medical purpose is as defined in the MDR, while the principal intended action must be achieved through a mode of action other than pharmacological, immunological or metabolic means.

The function of a medical device is achieved by physical means, including mechanical functions or replacement/support to organs or body functions.

The medical device guidelines (MEDDEV) 2. 1/3 rev. 3 on “Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative” provide clear definitions of pharmacological, immunological and metabolic means and examples of products that, although borderline, are either medical devices or medicinal products.

MDR provides that any device which incorporates, as an integral part, a substance which, if used separately, would be considered a medicinal product and has an action ancillary to that of the device, is assessed and authorised in accordance with MDR.

From a risk class perspective, all devices incorporating a medicinal product with ancillary function are classified as Class III.

A different conclusion on classification of the product is when a device and a medicinal product are placed on the market as a single integral product intended exclusively for use in the given combination and not reusable. These are devices used to administer a medicinal product fully integrated with it in a single product (eg, pre-filled syringes, aerosols containing a medicinal product). These products are governed by EU Directive 83/2001 or EU Regulation 726/2004, as applicable.

Neither cosmetics nor food supplements can be considered medicinal products and cannot claim to have any therapeutic effects nor any therapeutic purposes.

Food supplements may contain as ingredients substances also used as active ingredients in some medicinal products. The EU Commission identified few criteria to distinguish a food supplement from a medicinal product (despite the common ingredient).

Another category of borderline products is medical devices/personal protection equipment (PPE). PPE are governed by EU Regulation 425/2016 (PPE Regulation). Medical devices are governed by EU Regulations 745 and 746/2017. The main difference is that the purpose of PPE is to protect the wearer from safety hazards, while the purpose of the medical device is to guarantee, protect and support the health of a person other than the wearer, namely the patient. 

Medicinal Products

To manufacture medicinal products the manufacturer must hold a manufacturing licence granted by AIFA. All manufacturing operations must take place at authorised sites.

AIFA grants manufacturing authorisation upon inspection of the site to ensure compliance with good manufacturing practices set by EU Directive 94/2003 (GMPs). The authorisation procedure takes 90 days.

The qualified person (QP) must hold certain educational and professional requirements. The QP assures and guarantees compliance of batches manufactured at the site with applicable laws and conditions imposed by the competent authority; the QP is also responsible for reporting any non-conformity.

Medical Devices

Under European Regulation 2017/745 on Medical Devices (MDR) – which entered into force on 26 May 2021 – manufacturers must manufacture devices in accordance with the general safety and performance requirements of Annex I. Several provisions are related to design and manufacture to assure safety and quality of devices with the support of risk and quality management systems. The application for validation of the quality management system must include the name of the manufacturer and the address of its place of business and any additional sites covered by the quality management system, and, if the manufacturer's application is filed by its authorised representative, the name and address of the authorised representative.

One regulatory compliance person needs to be appointed to, amongst other obligations, check compliance of the manufacturing process with the quality management system before release of a device.

Manufacturers are also subject to certain registration requirements in the UDI Database, the European Database of Medical Devices (EUDAMED) and the Commission electronic system to obtain the release of a single registration number (SRN) to identify the manufacturer and, if applicable, its authorised representative or importer.

Competent authorities perform periodic audits (at least every 12 months) of the quality management system of manufacturer including on-site audits.

Blood Products

Manufacturing sites authorised to produce blood products must have an appropriate size, advanced technology and can manufacture only those products included in the framework agreements stipulated with regions and provinces.

Manufacturers must demonstrate that validated production and purification processes allow to constantly obtain homogeneous batches and guarantee, as far as permitted by technical developments, the absence of transmissible viral contaminants or pathogens.

Manufacturing sites must keep adequate documentation to go back from the final product to the initial blood donations from which the final blood product derives. Moreover, manufacturing sites for each and any batches of hemoderivatives must be in possession of documentation proving the origin of the plasma treated and used in that specific batch, compliance with GMP and all applicable EU laws and regulations as well as positive outcome of the state control.

Biocides

Towards full implementation of the BPR-Biocidal Products Regulation in Italy (due by 31 December 2024), products that were on the market before the entering into force of BPR, containing active substances under review in accordance with requirements provided by the new BPR, can still be manufactured and placed on the market in accordance with Presidential Decree 392/1998 and Order of the Ministry of Health of 5 February 1999 (and related Guidelines) as medical-surgical devices (“Presidi medico-chirurgici”).

Production of medical-surgical devices can take place in sites holding a manufacturing authorisation granted by the Ministry of Health.

Production of products with active substances approved in accordance with BPR are classified as biocides.

Manufacturing sites are subject to inspections and must have appropriate manufacturing process documentation on the quality and safety of the biocidal product.

Cosmetics

EU Regulations 1223/2009 (“Regulation on cosmetic products”) is the reference law.

The responsible person ensures compliance with obligations of the Regulation in terms of:

  • safety;
  • compliance with good manufacturing practices (GMPs);
  • traceability of the product (also required to distributors based on the one principle “one step back, one step forward”;
  • notification to the EU Commission prior to placing the product on the market;
  • compliance with restriction of use of certain substances;
  • labelling requirements;
  • reporting of serious undesirable effects and information on substances to the competent authority.

The Decree of the Minister of Health of 27 September 2018 sets out procedures for control of internal market for cosmetic products, of products, manufacturers, compliance with GMPs and obligations and communication requirements operators must fulfil according to vigilance and surveillance activities, as per Regulation on cosmetic products.

Personal Protection Equipment

Personal Protection Equipment (PPE) are designed to be worn or held by an individual for protection against safety hazards. PPE must comply with requirements provided for under EU Regulation 425/2016 (PPE Regulation).

The manufacturer is required to keep technical documentation of the PPE, as per Annex III of the PPE Regulation. The technical documentation shall specify the means used by the manufacturer to ensure the conformity of the PPE with the applicable EHSR in Annex II.

Legislative Decree 17/2019 amended national laws on PPE to make them consistent with PPE Regulation.

CBD (Cannabidiol)

The Decree of the President of the Republic 309/1990, also known as the “Consolidated text of the laws on the discipline of narcotic drugs and psychotropic substances, prevention, treatment and rehabilitation of the related drug addiction states” (the Narcotic and Psychotropic Drugs Code), is the reference law.

Narcotic or psychotropic substances are subject to supervision and control of the Ministry of Health. Cannabis is allowed for therapeutic purposes upon non-repeatable prescription and considering the specific pathological condition of the patient.

The Ministry of Health, every year, determines quantities of therapeutic/medical cannabis that can be manufactured and sold in Italy or abroad during the following year by the only thus far authorised manufacturer, the Chemical Pharmaceutical Military Plant of Florence.

Food and Nutrition Supplements

EU Regulation 852/2004 requires a food operator to notify the appropriate competent authority of each establishment (ie, manufacturing site) under its control, carrying out any stages of production, processing and distribution of food, with a view to register it. Food operators shall also ensure that the competent authority always has up-to-date information on establishments, including any significant change and closure of an existing establishment. Food operators must also ensure that the establishments are approved by the competent authority, following at least one on-site visit, when approval is required.

EU Regulation 853/2004 provides that manufacturers of food of animal origin must either register with or obtain a manufacturing authorisation by the competent authority for each establishment.

Legislative Decree 193/2007 identifies the Ministry of Health, the regions and the local health agencies as the competent authorities for application of EU Regulations 852 and 853 of 2004.

EU Regulation 625/2017 lays down detailed regulations on official controls.

EU Directive 46/2002 on food supplements (as amended and integrated, most recently by EU Regulation 418/2021) provides that national establishments manufacturing food supplements are subject to prior authorisation by the competent authority, identified by Law 189/2012 as the regions, autonomous provinces of Trento and Bolzano and the health agencies.

Authorisation can be suspended or withdrawn in case of lack of requirements listed above.

Inspections can be carried out at any time by the Ministry of Health.

Good manufacturing standards for food supplements are published in the form of recommendations by the Ministry of Health.

There are no legal obligations nor any law requirements on corporate social responsibility in Italy, which is a form of self-regulation. However, companies from different sectors have been increasingly investing resources in this field in the last few years, especially those active in sectors having or expected to have a social role and special responsibility towards the society, such as pharma, healthcare, life sciences and energy companies.

Some companies are nowadays used to disclosing their corporate social responsibility activities in their SEC or other national filings. Corporate social responsibility (CSR) in the past 12-18 months of the COVID-19 pandemic has been one of the most-discussed topics, especially with regard to the pharma and healthcare sectors that were expected to go beyond their statutory activities to contribute to the health of the general population.

In terms of environmental obligations, the reference law in Italy is Legislative Decree 152/2006 (the Environmental Consolidated Law) as subsequently amended (recently with Law Decree 77/2021).

Medicinal products are special waste regulated by Decree of the President of the Republic 254/2003 (DPR 254/2003). Sanitary waste is basically split into two macro categories of dangerous and non-dangerous sanitary waste. Depending on classification, there are different obligations for the producer of sanitary waste with regard to management, traceability, treatment, deposit, storage, transport, disposal, recording and reporting. 

Medicinal Products

Article 113 of Legislative Decree 219/2006 defines advertising of medicines. The legal framework is complemented by Guidelines of the Ministry of Health and/or the Italian Drug Agency (AIFA), regional regulations and code of regulation of the national pharma industry association (Deontological Code of Farmindustria).

Medicinal products with no national or European marketing authorisation cannot be advertised.

All elements of advertising must be consistent, with a summary of product characteristics, and advertising must be objective, encouraging rationale use of the product, not overstating the properties of the drug and not misleading.

Advertising to the public is not allowed except for over-the-counter (OTC) products or medicinal products that do not require a medical prescription dispensable by a pharmacist.

It is also forbidden to distribute to the public samples of medicinal products.

Advertising to the public cannot contain any elements that: 

  • make a doctor's consultation or surgery appear superfluous, in particular by offering a diagnosis or treatment by correspondence;
  • suggest that the efficacy of a medicinal product is free from undesirable effects or superior to or equal to another treatment or medicinal product;
  • suggest that medicine can improve the normal state of good health of the subject;
  • lead to the belief that failure to use the medicine may have detrimental effects on the normal state of good health of the subject (although this prohibition is not applicable to vaccination campaigns);
  • are aimed exclusively or mainly at children;
  • include a recommendation from scientists, healthcare professionals or persons widely known to the public;
  • assimilate the medicinal product to a food product, cosmetic product or other consumer product;
  • make improper, striking or deceptive reference to claims of recovery;
  • uses in an improper, striking or deceptive way visual representations of the alterations of the human body due to disease or injury, or of the action of a medicine on the human body.

Advertising of medicinal products to the public must be authorised by the Ministry of Health, with the exception of promotional messages in newspapers or the periodical press that reproduce in full the information of the leaflet, with a possible addition of a picture or graphic representation of the primary or secondary package.

Should the Ministry of Health not provide authorisation within 45 days from application, authorisation is deemed granted.

Advertising to is allowed to healthcare professionals authorised to prescribe or dispense medicinal product, and must comply with requirements and guidelines adopted by AIFA and Regions (Guidelines of the Conference of State-Regions adopted with Regulation of 20 April 2006).

Advertising to healthcare professionals must always include a summary of product characteristics, specify the class of reimbursement, and the price and condition of reimbursement by the National Healthcare System.

Specific additional constraints and requirements are also set:

  • by the Medicinal Product Code as of the distribution of medicinal products and documentation that can be showed and made available to attendees during conferences/congresses;
  • by the Agreement between Government, Regions of 2 February 2017 as of sponsoring of accredited educational events (Continuous Education in Medicine – ECM events);
  • by the Deontological Code of Farmindustria. 

Advertising on the web is subject to rules stated by the Medicinal Product Code integrated by Guidelines of the Ministry of Health. The general rule is that any information related to medicinal products requiring a medical prescription must be uploaded in a restricted area dedicated to healthcare professionals with credentials.

Use of social media (eg, Facebook, YouTube, Instagram) for promotion of OTC products is allowed with no interactions with the public, a proper disclaimer and additional requirements as set forth in the Guidelines of the Ministry of Health of 2017, amended in 2018.

Medical Devices

Advertising to the public is prohibited for medical devices which may be sold under medical prescription or used with the assistance of a doctor or other healthcare professional.

Advertising to the public of devices different from those above stated is subject to the authorisation of the Ministry of Health. The Ministry of Health has a 45-day term from submission of the request to approve or reject the application. In case of no response, advertising is deemed accepted and the authorisation granted.

Advertising to healthcare professionals is not subject to authorisation.

It is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or patient about the device's intended purpose, safety and performance.

In relation to advertising through new means of communication (eg, internet, toll-free numbers, email, SMS, MMS), the Ministry of Health issued the following guidelines:

  • Guidelines of 17 February 2010 on advertising of OTC, medical devices, in vitro medical devices, medical-surgical devices (“Presidi medico-chirurgici”) and veterinary medicinal products;
  • Guidelines of 28 March 2013 on advertising of medical devices, in vitro medical devices and medical-surgical devices;
  • Guidelines of 20 December 2017 on advertising of medical devices, in vitro medical devices and medical-surgical devices, with a particular focus on social media (integrated in 2019 as for Facebook).

Biocides

Advertisement of medical-surgical devices (“Presidi medico-chirurgici”) is subject to prior authorisation by the Ministry of Health. In general, manufacturers cannot use or distribute labels and promotional material that are not consistent with the ones approved by the Ministry of Health. The applicant must specify means of diffusion of advertising message. If the means of diffusion is social media, Guidelines of Ministry of Health of 20 December 2017 (as integrated in 2019 for Facebook) apply.

Any advertisement for biocidal products must include the following sentences “Use biocides safely. Always read the label and product information before use”.

Any advertisement for a substance classified as hazardous shall mention hazard classes or hazard categories concerned.

Cosmetics

Advertising of cosmetic product to the public is not subject to authorisation.

EU Regulation 655/2013 has, however, provided common criteria for justification of claims used in relation to cosmetic products, including for claims used in advertising messages related to those products. Six principles have been established by the Regulation:

  • legal compliance;
  • truthfulness;
  • evidential support;
  • honesty;
  • fairness;
  • informed decision-making.

The responsible person must make sure that all advertising messages comply with the six principles.

All advertising messages must comply with Legislative Decree 206/2005 (Italian Consumer Code) with reference to Articles 18-27 introduced in 2007 by Legislative Decree 146/2007 as part of implementation of the rules on business to consumer unfair commercial practices, as set forth in EU Directive 29/2005.

Curative claims are not allowed for cosmetic products.

Personal Protection Equipment

Advertising of Personal Protection Equipment (PPE) to public is not subject to prior authorisation.

All commercial practices and advertising messages must comply with rules set forth by Legislative Decree 206/2005 (Italian Consumer Code), with particular reference to Articles 18-27 introduced in 2007 as part of implementation of the rules on business to consumer unfair commercial practices set forth in EU Directive 29/2005, and with reference to Legislative Decree 146/2007 on misleading and comparative business-to-business advertising.

Advertising is also subject on a voluntary basis to the Code of Marketing Communication Self-Regulation.

Food and Nutrition Supplements

The general food law is EU Regulation 178/2002.

Advertising and presentation of food, including shape, appearance, packaging, packaging materials used, the manner in which they are arranged and the setting in which they are displayed, the information which is made available about them, cannot mislead consumers.

EU Regulation 1169/2011 deals with food information to consumers and provides more detailed provisions related to information to the public and fair commercial communication practices. These “food information practices” are, by explicit reference made by the Regulation, applicable to advertising as well – namely:

  • food information should not be misleading:
  • on characteristics of the food;
  • food information should not attribute to the food effects or properties which it does not have;
  • there should be no suggestion that the food possesses special characteristics when, in fact, all similar foods possess such characteristics;
  • food products should not suggest, by means of the appearance, the description or pictorial representations, the presence of a particular food or ingredient, while in reality a component naturally present or an ingredient normally used in that food has been substituted with a different component or a different ingredient;
  • food information should be accurate, clear and easy to understand for the consumer;
  • food information should not attribute to any food the property of preventing, treating or curing human disease, nor refer to such properties.

All messages must comply with rules set by Legislative Decree 206/2005 (Italian Consumer Code), with particular reference to Articles 18-27 introduced by Legislative Decree 146/2007 as part of the implementation of the rules on business-to-consumer unfair commercial practices as set forth in EU Directive 29/2005.

Food supplements are also subject to regulation provided by Legislative Decree 169/2004 implementing EU Directive 46/2002.

In case of products for which warnings are provided, the advertising message must contain an explicit invitation to read the warnings carefully.

Medicinal Products

Medicinal products cannot be placed on the market without authorisation from AIFA or European authorisation from the European Medicine Agency (EMA).

Applicants for marketing authorisation of generic products are not required to submit pre-clinical and clinical data results if it can be proven that the medicinal product is a generic medicine of a reference medicinal product (“originator”) authorised in Italy or at EU level.

Companies must maintain a positive risk-benefit balance for authorised medicinal products at all times, in compliance with pharmacovigilance obligations, including submission of periodic reports on product safety (PSURs) through the European Medicine Agency’s PSURs repository.

PSURs are not required for generic, homeopathic and traditional herbal medicinal products or products based on active substances which have a well-established medicinal use.

Medical Devices

Medical devices are currently undergoing changes to their legislative framework. New European Regulations, 2017/745 on Medical Devices and Active Implantable Medical Devices (MDR) entered into force on 26 May 2021 and EU Regulation 2017/746 on in vitro devices (IVDR) will enter into force on 26 May 2022; until then Directive 98/79/EC and Legislative Decree 332/2000 will continue to apply.

MDR introduces new requirements and obligations on pre-market, marketing authorisation and post-marketing:

  • different classes of risks and pre-marketing steps/approval processes;
  • new traceability system of medical devices with attribution to the device before placing it on the market of a Unique Device Identifier code (UDI);
  • introduction of a new European Database of medical devices (EUDAMED) that, when in force, will help to share and consult all information related to the medical devices marketed in Europe on a single platform;
  • plan, conduct and document a clinical evaluation in accordance with Article 61 of the MDR and Part A of Annex XIV of MDR;
  • plan, establish, document, implement, maintain and update a post-market surveillance system proportionate to the risk class of the device;
  • prepare a post-market surveillance report for Class I devices;
  • prepare a periodic safety update report (PSUR) for Class IIa, Class IIb and Class III devices and send it to notified body (for Class III devices);
  • report to the competent authority any serious incident and any field safety corrective action.

Biocides

EU Regulation 528/2012 concerns the making available on the market and use of biocidal products (Biocidal Products Regulation, BPR).

A marketing authorisation is required to commercialise biocides in Italy.

An applicant must submit a dossier containing all requirements of Annexes II and III for the biocide and the active substances.

The Ministerial Decree of 10 October 2017 identifies and defines the responsibilities of the Ministry of Health as the national competent authority over the monitoring and controlling of activities, demanding to subsequent agreement of the State-Regions Conference (signed on 6 December 2017, integrating a previous Agreement of 29 October 2009) the identification of specific competences of the regions and autonomous provinces for post-marketing surveillance activities.

Until full implementation of BPR, in Italy products containing active substances that are under review in accordance with the BPR requirements can be placed on the market in accordance with Presidential Decree 392/1998 as “Presidi medico-chirurgici” by submitting an application for marketing authorisation to the Ministry of Health and the National Institute of Health (ISS).

Personal Protection Equipment

Personal Protection Equipment (PPE) must comply with requirements provided by EU Regulation 425/2016 (PPE Regulation). PPE must meet the Essential Health and Safety Requirements (EHSR) listed and described in Annex II to PPE Regulation and must be CE marked.

Manufacturers must draw up the technical documentation referred to in Annex III of PPE Regulation and carry out or have carried out a conformity assessment procedure as per Article 19.

The technical documentation specifies the means used by the manufacturer to ensure the conformity of PPE with the applicable EHSR.

PPE is classified into three risk categories (Annex I):

  • Category I – PPE that can be placed on the market by the manufacturer with an EU Declaration of Conformity;
  • Categories II and III – PPE that must be pre-evaluated by a Notified Body that has to issue a Certificate of Conformity, pursuant to which the manufactured can produce a Declaration of Conformity.

Cosmetics

No marketing authorisation is required to market a cosmetic product in Italy but rather a notification requirement prior to placing the cosmetic product on the market to the Cosmetic Products Notification Portal (CPNP) of the EU Commission. The responsible person, as identified by EU Regulation 1223/2009 (“Regulation on cosmetic products”), has full responsibilities over the product that are assignable either to pre-marketing/upstream or to post-marketing downstream phases of a cosmetic product's life-cycle.

The responsible person is responsible to assure, amongst other requirements, compliant fulfilment of upstream or pre-marketing activities such as:

  • the safety of the product;
  • compliance of the manufacturing process with good manufacturing practices (GMPs);
  • ensuring a cosmetic product safety report is set up in accordance with Annex I of the Regulation;
  • complying with the notification procedure to the Cosmetic Products Notification Portal (CPNP) of the EU Commission prior to placing the cosmetic product on the market.

The responsible person is also obligated to assure compliant fulfilment of downstream or post-marketing activities such as:

  • compliance with labelling requirements;
  • compliance of the product claims on the labelling and advertising with rules and limits provided by law;
  • traceability of the product throughout the supply chain (also required to distributors based on the principle “one step back, one step forward”)
  • access by the public to information on cosmetic product and existing data on undesirable and serious undesirable effects;
  • communication to the competent authority of serious undesirable effects;
  • collaboration with competent authority on post-marketing surveillance activities.

Post-marketing surveillance responsibilities, controls and procedures are as defined by Decree of the Ministry of Health of 27 September 2018. The Ministry of Health, as the Italian competent authority, oversees compliance with EU Regulation with the collaboration of regions and autonomous provinces.

As part of market surveillance, said Decree requires manufacturers, within 30 days from the start of manufacturing activities at each site, to send a communication to both the Ministry of Health and the region where the site is located with at least the following information:

  • name of the manufacturer;
  • full address of the site;
  • list of cosmetics manufactured at the site;
  • indication of the activities performed at the site (eg, phase of the manufacturing process, packaging, labelling).

Food and Nutrition Supplements

The general food law is EU Regulation 178/2002.

Surveillance of the market is ruled by EU Regulations 852/2004 and 853/2004 dictating strict requirements and rules related respectively to hygiene of general foodstuffs and food of animal origins. Manufacturing sites (called “establishments” in the Regulations) need to be communicated, registered or authorised with and by the competent authority.

EU Regulation 625/2017 provides specific rules on organisation of official controls.

In Italy, competent authorities for market surveillance and controls are the Ministry of Health, the regions and local health agencies.

EU Directive 46/2002 concerns food supplements. Commercialisation of food supplements in Italy is subject to a labelling notification procedure to the Ministry of Health at the time of first commercialisation.

The international mission of Italian companies is influenced by different but connected factors such as the size of a company – small, medium (so-called PMI) and large – cost of raw materials, cost of manufacturing of the finished products and general cost of goods (COGS), tax regimes and incentives, labour costs, bureaucracy, export intensity and geographic dispersion of the sales, size and maturity of the internal market, sub-contracting of phases of manufacturing process, CMO arrangements, local or global outsourcing, etc.

Some of these factors can be considered as leading to some level of internationalisation of a company, but do not derive from a planned and robust internationalisation strategy and investment plan, as such. This is often due to lack of financial and technological resources or lack of adequate management skills and vision.

Depending on sectors, the regulatory regime might also play a role in determining or influencing internationalisation processes, although companies operating in heavily regulated sectors (eg, pharmaceuticals, medical devices, life sciences) and aspiring to sell products globally cannot prescind from sticking and complying with strict regulatory rules and controls.

Medicinal Products

A marketing authorisation holder (MAH) must always maintain a positive risk-benefit balance for its authorised medicinal products.

An MAH must possess adequate pharmacovigilance and a risk-management system managed by a pharmacovigilance-qualified person who is an EU resident and in possession of appropriate professional requirements.

An MAH must record all suspected adverse reactions in the EU or third countries, brought to its attention spontaneously by patients or healthcare professionals, or occurring in the context of post-marketing studies.

An MAH must transmit to the European Union Drug Regulating Authorities Pharmacovigilance, EudraVigilance, all adverse reactions in the EU or third countries:

  • within 15 days from knowledge of the event for serious suspected adverse reactions;
  • within 90 days from knowledge of the event for non-serious suspected adverse reactions.

An MAH is also required to submit periodic reports on product safety (PSURs) through the EMA’s PSURs repository according to the indication of the MA (or for MAH granted before 21 July 2012):

  • every six months in the first two years from authorisation;
  • once per year in the following two years; and
  • every three years afterwards.

CBD (Cannabidiol)

Post-marketing surveillance of suspected adverse reactions to medicinal products based on cannabidiol (CBD) is co-ordinated by the Superior Institute of Health (Istituto Superiore della Sanità, ISS) and is carried out through the collection of reports of suspected adverse reactions associated with the administration of named galenic preparations derived from cannabis.

Healthcare professionals who observe a suspected adverse reaction must promptly notify the ISS within two working days from the reaction through the report form on the websites of the ISS, the Ministry of Health and AIFA.

Medical Devices

European Regulations 2017/745 on Medical Devices and Active Implantable Medical Devices (MDR) and 2017/746 on in vitro medical devices (IVDR) introduce safety and vigilance obligations similar to that for pharmaceuticals.

The MDR is in force since 26 May 2021. IVDR will be applied starting 26 May 2022; until that date, Directive 98/79/EC and Legislative Decree 332/2000, transposing it in the Italian system, will continue to apply.

In accordance with the MDR, for each device, manufacturers must plan, establish, document, implement, maintain and update a post-market surveillance system proportionate to the risk class of the device.

Data gathered through the post-market surveillance system are used to reassess and update the risk-benefit ratio of the device, to update the design and manufacturing and the instructions for use and to improve the safety of the device. If, during the post-market surveillance, a preventive or corrective action is needed, the manufacturer must implement it and inform the competent authorities and, where applicable, the notified body.

Manufacturers of Class IIa, Class IIb and Class III devices must prepare a periodic safety update report (PSUR) for each device summarising the results and conclusions of the analyses of the post-market surveillance data as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. 

Manufacturers are also required to report to competent authority, which in Italy is the Ministry of Health:

  • any serious incident involving devices made available in the EU, not later than 15 days after they become aware of the incident (ten days in case of death or most serious life-threatening cases);
  • any field safety corrective action (FSCA) of devices made available in the EU before implementing the corrective action (except in cases of urgency).

Following the reporting of a serious incident, the manufacturer must investigate the serious incident and the device concerned. Such investigation includes risk assessment and possible field safety corrective actions. The manufacturer must provide a final report (Manufacturer Incident Report, MIR) to the Ministry of Health, with its findings setting out conclusions and corrective actions needed.

Field safety corrective actions must also be reported to the users of the device by means of a field safety notice (FSN).

Additional guidance on safety reporting activities and remedial actions are in the Guideline MEDDEV 2.12-1 rev.8 and the Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8, and, at national level, in the Decree of the Ministry of Health of 15 November 2005.

Italian legislation on MDs, in particular Legislative Decree 46/97, is currently under review pursuant to Law 53/2021 of 22 April 2021 in order to make it consistent with the MDR. The Italian legislator has one year from the publication of Law 53/2021 to make the necessary changes to the Legislative Decree 46/97 to make it consistent with the MDR.

Currently, according to Decree of the Ministry of Health of 15 November 2005, healthcare professionals of both public and private institutions must report an incident or missed incident, directly or through their institutions to the Ministry of Health and, possibly, also to the manufacturer or authorised representative and/or distributor of the medical device with the utmost urgency.

The incident must be reported not later than:

  • ten days from the event for incidents;
  • 30 days from the event for near misses.

The Manufacturer Incident Report (MIR) to the Ministry of Health, with the manufacturer’s findings setting out conclusions and corrective actions, is due within 30 days from the reporting of the incident.

As to in vitro medical devices (IVDR), EU Regulation 2017/746 – which provides, mutatis mutandis, provisions similar to the MDR – will be applicable starting 26 May 2022; until that date, Directive 98/79/EC and Legislative Decree 332/2000 will continue to apply. Article 11 of Legislative Decree 332/2000 provides for surveillance and reporting obligations to the Ministry of Health of any serious incident involving a device.

Personal Protection Equipment

Personal Protection Equipment (PPE) are products designed to be worn or held by an individual for protection against safety hazards. PPE must comply with the requirements provided for under the EU Regulation 425/2016 (PPE Regulation).

The national legal framework has been amended to make it compatible with EU Regulation 425/2016 and with Legislative Decree 17/2019.

All PPE must meet Essential Health and Safety Requirements (EHSR) described in Annex II to PPE Regulation and must be CE marked. The technical documentation that the manufacturer is required to draft must include a list of the EHSR applicable to the specific PPE.

In Italy, post-marketing surveillance functions and obligations are performed by the Ministry of Economic Development and the Ministry of Labour.

Biocides

EU Regulation 528/2012 concerns the making available on the market and the use of biocidal products (Biocidal Products Regulation, BPR).

The Ministerial Decree of 10 October 2017, covering national controls on biocides placed on the market, in accordance with Article 65 of EU Regulation 528/2012, defines the responsibilities of the Ministry of Health as the national competent authority over monitoring and control activities demanding to subsequent agreement of the Conference of State-Regions (signed on December 2017 and integrating a previous Agreement of 29 October 2009) to identity the specific competence of regions.

An MAH must keep records of the biocidal products placed on the market for:

  • at least ten years after placing on the market; or
  • ten years after the date on which the MA was cancelled or expired, whichever is the earlier.

Cosmetics

EU Regulations 1223/2009 is the relevant regulation on cosmetic products.

The basic principle set forth in the Regulation is that a responsible person must be designated within the EU to place the cosmetic products on the market.

The responsible person's obligation include post-marketing surveillance activities.

The responsible person who considers that a cosmetic product placed on the market is not compliant with the EU Regulation must immediately take the corrective measures necessary to make the product compliant, withdraw it or recall it, as appropriate.

Where the cosmetic product presents a risk to health, the responsible person must immediately inform the competent authorities of the member states where the product was made available and of the member state where the product information file is readily accessible, detailing the non-compliance and the corrective measures taken.

As for serious undesirable effects, the responsible person (and distributors) must notify the competent authority of the member state (in Italy, the Ministry of Health) where the serious undesirable effect occurred.

Food and Nutrition Supplements

The general food law is EU Regulation 178/2002. Regulation 178/2002 reinforces the rules on the safety of food in the EU.

If a food business operator considers that a food it has imported, produced, processed, manufactured or distributed is not compliant with food safety requirements, it shall (i) immediately initiate procedures to withdraw the food from the market where the food has left the immediate control of that initial food operator, and (ii) inform the competent authorities.

A food operator must immediately inform the competent authorities if it considers that a food it placed on the market may be injurious to human health. Operators must inform the competent authorities of the action taken to prevent risks to the final consumer.

This “traceability” principle leaves to food operators the freedom to determine how best to comply with it in order to identify the batches that are not compliant with safety requirements so to avoid massive recalls; see also Agreement of the State-Regions Conference of 28 July 2005 and 5 May 2021 on the National Guidelines for the functioning of Rapid Alert System of Food and Feed – RASFF, as provided for by Article 35 of Regulation 178/2002.

EU Regulation 625/2017 provides specific rules for the organisation of controls. Legislative Decree 27/2021 harmonised national legislation to EU Regulation 625/2017, and indicated the Ministry of Health, the regions, and local health agencies as the competent authorities for controls.

EU Directive 46/2002 specifically concerns food supplements. EU Directive 46/2002 has been implemented in Italy with Legislative Decree 169/2004 which also provides for a vigilance annual plan to be agreed by the Ministry of Health in agreement with the State-Regions Conference.

The Italian regulatory authorities are as follows.

Medicinal products:

  • Ministry of Health;
  • Italian Drug Agency, AIFA;
  • European Medicine Agency, EMA.

Medical devices:

  • Ministry of Health (Directorate of Medical Devices and Pharmaceutical Services).

Blood products:

  • Ministry of Health;
  • Italian Drug Agency, AIFA.

CBD:

  • Ministry of Health;
  • Superior Institute of Health, ISS.

Personal Protection Equipment:

  • Ministry of Economic Development;
  • Ministry of Labour.

Food and nutrition supplements:

  • Ministry of Health.

Biocides:

  • Ministry of Health;
  • European Chemicals Agency, ECHA;
  • EU Commission.

Cosmetics:

  • Ministry of Health.

Medicinal Products

Ministry of Health

The Ministry of Health is in charge of general guidelines and vigilance of the activities of AIFA.

AIFA

AIFA oversees assessment, review, authorisation, supervision, monitoring of the development, manufacturing, price and reimbursement conditions, promotion and sale of medicinal products.

AIFA is responsible for the following activities:

  • granting national manufacturing authorisation;
  • granting marketing authorisation;
  • negotiation and determination of sale price and reimbursement conditions;
  • continuous evaluation of the risk profile of products;
  • imposing post-marketing safety and/or efficacy studies to be carried out by the MAH;
  • inspections/audits;
  • management of the national pharmacovigilance system and national pharmacovigilance network (RNF);
  • suspension, modification or revocation of the marketing authorisation;
  • sales ban, recalls, withdrawal from the market of a medicinal product;
  • suspension or withdrawal of the manufacturing authorisation.

EMA

The European Medicine Agency (EMA), established by the EU Regulation 726/2004, is responsible for the scientific evaluation, supervision and control of the safety of medicinal products at EU level.

It is responsible for reviewing EU centralised marketing authorisations for the following product categories:

  • biotech drugs;
  • new active substances for specified diseases;
  • orphan medicinal products;
  • advanced therapy medicinal products (ATMPs);
  • optional for other substances –
    1. that are a significant therapeutic, scientific or technical innovation,
    2. in the interest of public health at EU level;

Two key committees within EMA are:

  • the Committee for Medicinal Products for Human Use (CHMP);
  • the Pharmacovigilance and Risk Assessment Committee (PRAC).

The Commission has authority to grant, refuse, vary, suspend, withdraw, or revoke a marketing authorisation, and impose penalties for non-compliance with the obligations relevant to marketing authorisations.

Medical Devices

The Ministry of Health (Directorate of Medical Devices and Pharmaceutical services) has supervision and surveillance powers over the medical device’s safety and conformity with applicable laws and regulations.

The Ministry can:

  • order withdrawal/recall from the market;
  • impose a sales ban;
  • prevent placing on the market or into service of the device;
  • issue orders and corrective actions to manufacturers for ascertained non-conformity of their products with sanctions in case of non-compliance.

The Ministry is the addressee of any communications from the manufacturer of incidents involving a medical device and any communications from healthcare institutions and healthcare professionals.

The Ministry is responsible for qualifying and authorising applicants as approved notified bodies and supervises the notified bodies and persistence of legal requirements.

The Ministry is also empowered to carry out announced/unannounced inspections and audits to sites and warehouses.

Personal Protection Equipment

The Ministry of Economic Development and the Ministry of Labour are responsible of surveillance of the market of PPE.

The Ministry of Economic Development and the Ministry of Labour:

  • carry out safety evaluation of PPE if they believe there is a risk to health or safety;
  • require manufacturers to provide all information and documentation to demonstrate the conformity of PPE with PPE Regulation;
  • require economic operator to implement corrective actions to bring the PPE compliant with requirements of PPE Regulation or to order the withdrawal from the market or recall as appropriate;
  • authorise, approve and revoke the notified bodies;
  • apply sanctions in case of non-compliance.

Food and Nutrition Supplements

The Ministry of Health is empowered to:

  • register or authorise food establishments (manufacturing sites), as applicable;
  • receive labelling notification from manufacturers of food supplement before commercialisation, register the supplement in a dedicated registry and assign it with a specific code;
  • carry out investigations and controls and with local competent authorities, inspections, usually unannounced, of establishments;
  • evaluate major and minor non-conformities;
  • order implementation of appropriate measures to ensure that the operator remedies the non-compliance and prevents further occurrences of such non-compliance;
  • order the recall, withdrawal, removal and destruction of goods;
  • proceed to seizure or block of equipment, premises, establishments, goods or animals.

National establishments manufacturing food supplements are also subject to prior authorisation and surveillance by the competent authority as identified in Law 189/2012 (ie, the regions and local health agencies).

Cosmetics

The Ministry of Health, as Italian competent authority, is empowered to:

  • oversee compliance with EU Regulation 1223/2009 with the collaboration of the regions and autonomous provinces;
  • require the product information file of the cosmetic product from the manufacturer;
  • define the "multiyear plan" for control of the market and assure functioning and effectiveness of the control system and co-ordination with different local authorities;
  • collect the data of the activities and inspections carried out by the regions and autonomous provinces;
  • impose corrective actions to the responsible person and/or to distributors;
  • order withdrawal or recall of the cosmetic product from the market;

Biocides

The General Directorate of Medical Devices and Pharmaceutical Services of the Ministry of Health drafts and approves the Annual National Control Plan on biocides, based on data, information and results of controls and surveillance made at local level in the territory.

The Ministry, with the help of other central administrations and the regions and autonomous provinces, is empowered to control conformity of biocides with EU Regulation 528/2012 (BPR).

The Ministry of Health is empowered to grant marketing authorisations at national level to local applicants and amend or cancel any such authorisations. As of products containing active substances under review in accordance with BPR requirements and that can be placed on the market in accordance with Presidential Decree 392/1998 as “Presidi medico-chirurgici”, the national application for marketing authorisation is reviewed and approved by the Ministry of Health and the National Institute of Health (ISS).

Medicinal Products

Typical product safety offences are:

  • promotion and sale of medicinal product without marketing authorisation or a marketing authorisation suspended or revoked;
  • production of medicinal products without manufacturing authorisation or authorisation suspended or revoked;
  • promotion of the medicinal product outside approved indications;
  • production and distribution of falsified or illegal products;
  • theft and laundering of medicinal products;
  • lack of compliance by the manufacturer with indications provided by AIFA in accordance with Article 57, Section 7 of Code of Medicinal Products;
  • lack of compliance with quality controls;
  • commercialisation of medicinal product with the packaging and leaflet different from the ones approved by AIFA;
  • lack of compliance with updates of the summary of product characteristics on safety aspects of medicinal product.

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

Criminal sanctions are issued against individuals, although certain criminal offences may trigger corporate criminal liability, pursuant to Legislative Decree 231/2001.

Medical Devices

Typical product safety offences are:

  • lack of compliance with essential requirements and non-conformity with and of the CE marking;
  • lack of compliance with the market surveillance requirements, omission of safety reporting to the Ministry of Health by healthcare organisations, healthcare professionals and/or manufacturers;
  • placing on the market or putting into service of medical device without a CE mark or certification of conformity;
  • lack of reporting of incidents to the Ministry of Health by healthcare organisations and/or healthcare professionals;
  • lack of communication by manufacturers to the Ministry of Health of withdrawal from the market of a medical device due to technical or medical inconveniences;
  • lack of communication to the Ministry of Health of customised medical devices placed on the market, registration of manufacturer and lack of transmission of the CE certification of conformity upon request;
  • lack of archival documentation and unavailability of technical documentation of the medical device for a period of five years.

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

Personal Protection Equipment

Typical product safety offences are:

  • manufacturing or placing on the market by the manufacturer or importer of a PPE not compliant with Essential Health and Safety Requirements;
  • lack of compliance by distributors of their obligations as laid down in Article 11 of the EU Regulation 425/2016 (PPE Regulation);
  • lack of compliance by the manufacturer with the conformity assessment procedures as set forth at Article 19 of the PPE Regulation;
  • absence of an EU declaration of conformity;
  • placing into market of a PPE without the EU declaration of conformity;
  • putting unclear, misleading or confusing marks, signs or other inscriptions on the PPE;
  • promotion of advertising of PPE in breach of PPE Regulation;

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

Cosmetics

Typical product safety offences are:

  • violations of safety requirements and obligations by manufacturing, possessing or placing into market cosmetics dangerous to consumers’ health;
  • lack of compliance by the responsible person of his or her market surveillance duties and lack of implementation of remedial actions (CAPA, withdrawal, recall, non-reporting);
  • lack of compliance with GMPs;
  • placing into market of cosmetics with no safety assessment and without a product safety report;
  • placing into market of cosmetics without required notification to the Cosmetic Products Notification Portal (CPNP) of the EU Commission prior to placing the cosmetic product on the market;
  • placing into market of cosmetics containing nanomaterials without prior notification to the Cosmetic Products Notification Portal (CPNP);
  • placing into market of cosmetics of which labelling, advertising, presentation, trade marks or other signs attribute to the cosmetic characteristics of functions untrue, inaccurate or not existing. 

Legislative Decree 204/2015 has established the regulatory regime applicable to the provisions of EU Regulation 1223/2009.

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

Biocides

Typical product safety offences are:

  • placing into market or use of a biocide without authorisation in accordance with EU Regulation 528/2012 (BPR);
  • lack of compliance with rules set forth by the BPR on conduct of scientific or product and process-orientated research and development involving an unauthorised biocidal product or a non-approved active substance;
  • manufacturing or placing into market of a medical-surgical devices (“Presidi medico-chirurgici”) without authorisation or in violation of the authorisation granted;
  • absence, lack of archival or unavailability for the competent authority of technical documentation related to R&D;
  • lack of compliance of the classification, packaging and labelling of the biocide with the requirements of the summary of biocidal product characteristics;
  • lack of documentation on safety and quality of the biocide product and refusal to submit to controls;
  • violation of the notification obligations of unexpected or adverse effects.

Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

Criminal sanctions are issued against individuals although certain criminal offences may trigger the corporate criminal liability pursuant to Legislative Decree 231/2001.

A scheme of legislative decree for adoption of the regulatory regime related to the application of EU Regulation 528/2012 is currently under evaluation and discussion in the Italian Parliament, pursuant to Law 117/2019. Criminal and administrative sanctions for violations of the biocide requirements are currently set forth in Legislative Decree 174/2000 which implemented the EU Directive 8/1998.

Food and Nutrition Supplements

Typical product safety offences are:

  • lack of implementation by food operators of a traceability system throughout the manufacturing, transformation and distribution processes;
  • violation of obligations of withdrawal from the market of food not compliant with food safety requirements;
  • violation of reporting and information requirements to competent authority related to withdrawal from the market;
  • lack or refusal to collaborate and provide data and information required by the competent authority;
  • violation of the obligation to inform the consumers who have been reached by the product of any withdrawal/recall of food products.

Legislative Decree 190/2006 established the regulatory regime applicable to EU Regulation 178/2002. Offences can represent either criminal or administrative offences.

Typical product safety offences for food supplements are:

  • violation of the obligation to manufacture food supplements containing as ingredients only the vitamins and minerals allowed by the EU Directive 46/2002 and Legislative Decree 169/2004;
  • violation of the labelling, advertising obligations and requirements;
  • manufacturing and packaging of food supplements without manufacturing authorisation;
  • placing on the market food supplements without prior labelling notification to the authority;
  • violations of the obligations related to labelling, presentation and advertising of supplements.

Legislative Decree 169/2004 established the regulatory regime applicable to the provisions of EU Directive 46/2002. Offences can represent either criminal or administrative offences. Depending on their classification, they have a different regime of sanctions/penalties.

EU Directive 374/85 on General Product Liability was implemented in Italy with Presidential Decree 224/1988, as amended by Legislative Decree 25/2001 subsequently incorporated into Legislative Decree 206/2005 (the Consumer Code).

The Consumer Code provides a strict liability that can be claimed by consumers for damages caused by a defective product. This liability is alternative to contractual and tort liabilities governed by the Civil Code.

Article 2043 of the Italian Civil Code sets the tort liability to be based on the duty of care concept.

Article 2050 of the Italian Civil Code provides for strict liability (ie, presumption of liability) for those who exercise a per se dangerous activity.

Under the Consumer Code, the manufacturer is the first subject liable for damages caused by defective product.

The distributor may also, residually, be held liable, in cases where the manufacturer is not identified.

The manufacturer can escape liability if it is able to demonstrate that the defect, the damage or the casual link does not exist.

Jurisdiction over disputes related to personal rights between private parties or private/public parties lies with the Ordinary Civil Courts:

  • lower courts (Giudice di pace) for minor and low value claims;
  • civil tribunals for first instance;
  • Courts of Appeal for second instance; and
  • Supreme Court as third and last instance.

Within the ordinary civil courts there are specialised sections, the tribunals of enterprises (or enterprises courts) specialised in disputes over specific business matters and intellectual property rights.

Administrative courts have jurisdiction over disputes around the legitimate interests of individuals or people vis-à-vis the acts, orders and determinations of public administrations:

  • Regional Administrative Tribunals (first instance administrative courts); and
  • Council of State (administrative Court of Appeal located in Rome).

The Italian Constitutional Court has jurisdiction over:

  • cases of constitutional legitimacy of laws, acts having force of law of the state and the regions;
  • conflicts on the allocation of powers among the branches of the state, among the state and the regions, and among the regions;
  • charges brought against the President of the Republic.

The judge orders the losing party to refund the legal costs in favour of the counterparty and quantifies them usually on a fixed basis, based on the amounts provided for by Ministry Decree 55/2014.

In doing so, usually the judge excludes costs deemed excessive or unjustified.

However, the judge may also decide to compensate, fully or partially, the costs between the parties.

Acts, decisions or determinations of public administrations affecting legitimate interests of individuals can be challenged before the administrative courts. The regional administrative tribunal of Lazio (TAR Lazio) has jurisdiction over acts and decisions of the Italian Drug Agency (AIFA) and of the Ministry of Health. Decisions of administrative tribunals can be appealed before the Council of State (Consiglio di Stato, the administrative Court of Appeal, located in Rome). 

There are many examples where the determinations/decisions of the Italian Drug Agency have been challenged in court by pharmaceutical companies (eg, legal actions versus the pay-back, the legal mechanism requiring all pharmaceutical companies to pay back to regions the over-expenditure of reimbursed medicinal products vis-à-vis the budget allocated to them). Other contentious areas are price negotiation and reimbursement conditions of medicinal products. 

With “mass tort” litigations, we generally define cases where damages or injuries are caused to multiple individuals with the same act/event or chain reactions caused by a continuative behaviour such as the sale in a given period of time of a defective or unsafe product. This can typically be the case with a medicinal product administered to several patients or an inherently defective medical device due to manufacturing or design defects.

The definition of “mass tort” also includes man-made disaster torts such as natural disasters, environmental disasters and transport incidents.

Mass tort litigation differs from class action. In mass tort litigations, plaintiffs are not considered as a single entity as in the class action, but rather individually, and can seek compensation for their specific injuries.

In the Italian legal system, unlike the class action, which is typically regulated by law, there are no specific provisions regulating mass tort litigation.

Class actions are litigations where a large group of plaintiffs is considered a class and is represented by an individual "class representative". The class representative stands in court for the class and all members are treated as one plaintiff.

In May 2021, a new regulation for class action was introduced. The new regulation is now incorporated into the Italian Code of Civil Procedure and abrogated relevant measures on class action that were included into Legislative Decree 206/2005 (Italian Consumer Code). The new regulation is applicable to the illicit conducts committed after its entry into force; for conducts that occurred before (ie, before 18 May 2021), the old regulation of the Consumer Code will continue to apply.

Pursuant to Italian legislation, individual homogeneous rights can be protected by means of a class action. Entities entitled to initiate a class action to seek compensation for damages or restitution are:

  • each individual/consumer member of the class;
  • consumers’ associations and/or not-for-profit organisations having as statutory objective the protections of rights violated, provided that the class action is to protect “individual homogeneous rights” and that such associations and organisations are registered in a public list held by the Ministry of Justice.

The proceeding on the merit is subject to a preliminary filter of the admissibility of the demand.

Unlike the USA, where an “opt-out” mechanism is adopted, Italian legislation provides for an “opt-in” mechanism to join a class action. If the action is considered admissible by order of the judge, a term between 60 and 150 days from the date of the publication of the order is granted to allows other members of the class to “opt-in”.

ADR mechanisms available are:

  • amicable settlement;
  • judicial or extra-judicial conciliation;
  • arbitration;
  • mediation with the help of an independent and impartial person.

Product liability cases might also entail a criminal liability, especially in cases where the harmful event is caused by lack of quality or compliance with safety requirements, either intentional or due to negligence. In particular for categories of goods that are strictly related to health and aimed at safeguarding the health and safety of the users and patients, a civil liability or administrative dispute can flow into a criminal investigation.   

The Next Generation EU Plan, adopted by the EU to foster the economic recovery of EU countries affected by the COVID-19 pandemic, has triggered the adoption by the Italian government of the National Recovery and Resilience Plan (RRP). Among many areas of planned interventions, the RRP provides for investments to modernise the technological base of Italian hospitals. The investment involves:

  • the digital modernisation of the existing technologies whose obsolescence is greater than five years through the purchase of 3,133 new items of high-tech equipment;
  • interventions aimed at enhancing level of digitalisation of hospitals.

This modernisation and digitalisation should guarantee a more efficient, safer, more eco-friendly, less energy-demanding and more reliable technology aimed at having a positive impact on the environment, as well as on the health and safety of patients.

On 25 November 2020, the EU Commission adopted its Pharmaceutical Strategy for Europe. As part of it, the EU Commission is working on the following:

  • revision of EU general legislation on medicinal products;
  • revision of EU orphan and paediatric legislation;
  • revision of EU legislation on health technology assessment;
  • legislative proposal on a European Health Data Space;
  • optimising the supplementary protection certificates system, to make it more transparent and efficient, as foreseen in the EU Intellectual Property Action Plan.

Medical devices are in the midst of a transition phase, with gradual implementation of EU Regulation 745/2017 (MDR) and of EU Regulation 746/2017 (IVDR) due in May 2022. Italian legislation on medical devices, in particular Legislative Decree 46/97, is currently under review pursuant to Law 53/2021, to make it consistent with the MDR.

Several legislative initiatives are also foreseeable in the near future for the implementation of the objectives of the National Recovery and Resilience Plan (RRP).

Brexit, particularly after the end of the transition period (31 December 2020) had a huge impact on regulated industries such as pharmaceutical and medical devices.

To mention just a few consequences on medicinal products:

  • marketing authorisation holders of EU centralised authorisations can no longer be located in the UK;
  • qualified persons for pharmacovigilance can no longer be based in the UK;
  • the pharmacovigilance master file cannot be maintained within the territory of the UK;
  • medicinal products or active substances manufactured and/or released in the UK are considered as imported goods when imported within the EU.

Most of the regulatory changes and consequences are not applicable to Northern Ireland, which has been given a special regime due to its geographic proximity to the Republic of Ireland and thereby its specific political ties to the EU.

Two important consequences on medical devices are:

  • notified bodies of the UK have lost their status as notified bodies of the EU and can no longer evaluate and release any certification of conformity pursuant to EU laws and regulations;
  • manufacturers whose certification has been released by a notified body based in the UK must apply for a new certification before a notified body of the EU or ask for the transmission of the file and of the certification released by a UK-notified body to an EU-notified body that will take responsibility of it.

COVID-19 had a huge impact in terms of special legislation swiftly promulgated with to face the state of emergency and to meet the increasing demand for intensive care medical devices, such as ventilators, intensive care monitoring devices, surgical masks and personal protection equipment.

Avvocati Associati Franzosi Dal Negro Setti

Via Brera 5
Milan
Italy

+39 02 859 09260

lifesciences@franzosi.com www.franzosi.com
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Law and Practice

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Avvocati Associati Franzosi Dal Negro Setti is a member of the European network Conférence Bleue, which since 1997 has united leading firms in the pharmaceutical, health and medical fields, ensuring efficient delivery of highly specialised legal services on a multi-jurisdictional level. The firm's life sciences team offers assistance and consulting services in all aspects concerning research, manufacturing, commercialisation and use of medical products and veterinary products, medical devices, special foods and cosmetics. Representation in litigation is carried out before all competent authorities: ordinary civil courts, specialised IP divisions, administrative courts and European courts. The team also acts for clients in arbitration and proceedings before independent authorities or self-regulatory bodies, such as the Institute of Advertising Self-Regulation (IAP), and assists clients in out-of-court cases concerning regulatory aspects of pharmaceutical marketing authorisation with reference to issuance, maintaining, review and protection. Furthermore, it offers assistance and consulting services on price negotiation systems and classification of drugs for reimbursement by the Italian National Health Service.

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