Legal & Regulatory > Italy > Marketing, Manufacturing, Packaging & Labeling, Advertising

All about marketing, manufacturing, packaging & labeling, advertising in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.

1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the-counter medications, and other medicinal products?

a. Medicinal Products

As a general rule, medicinal products may only be placed on the market once authorization has been granted by the competent authorities. As detailed below – except for the centralized procedure – marketing authorizations in Italy are granted by AIFA in accordance with the following procedures:

• National procedure: national authorization valid in Italy only;
• Mutual recognition procedure: national authorization based on the recognition of a marketing authorization already issued by another member state of the European Economic Area (“EEA”);
• Decentralized procedure: national authorization granted in Italy and one or more other EU member state in parallel in case no authorization had been previously granted within the EU;
• Centralized procedure: a marketing authorization granted by the European Commission based on EMA’s recommendation and valid in all EU member states as well as in the EEA. The centralized procedure is compulsory for some medicines (e.g. medicines containing a new active substance to treat HIV, AIDS, cancer or other diseases; medicines derived from biotechnology processes such as genetic engineering; advanced-therapy medicines such as gene-therapy, somatic cell-therapy or tissue-engineered medicines) and optional for others (e.g. medicines with significant therapeutic, scientific or technical innovation).

To obtain a marketing authorization, the applicants must be established in the EU and submit a dossier including, among other things:

• business name and registered office of the applicant and, where applicable, of the manufacturer;
• name of the medicinal product;
• qualitative and quantitative particulars of all components of the medicinal product listed;
• description of the manufacturing method;
• therapeutic indications, contraindications and adverse reactions;
• posology, pharmaceutical form, method and way of administration and expected shelf life;
• results of the pharmaceutical tests, pre-clinical tests and clinical trials;
• a summary of the pharmacovigilance system;
• a summary of the product characteristics (“SmPC”), one or more specimens or mock-ups of the outer packaging and the immediate packaging of the medicinal product, together with a package leaflet.

Additionally, in case of application following the mutual recognition or decentralized procedure, the applicant is required to:

• include a list of all the member states in which an application has been filed or an authorization granted (“Concerned member states”);
• confirm that the efficacy and safety profile, the SmPC, package leaflet and labeling are identical in all Concerned member states.

b. Medical Devices

Medical devices do not require a prior authorization from the Ministry of Health to be placed on the market in Italy. However, the manufacturer is responsible for ensuring that the medical device complies with the essential requirements set forth by legislative decree 46/1997 and it has been subject to appropriate tests to verify such conformity.

All medical devices require a “CE mark” to be placed on the market. In order to affix the CE mark, the manufacturer must follow a conformity assessment procedure. For Class I devices, the manufacturer draws up the EC declaration of conformity after having verified compliance with the applicable requirements. For Class IIa, IIb, or III devices, the manufacturer must involve a Notified Body – i.e., a private legal entity designated by the competent regulatory authority to exercise conformity assessment procedures. The Notified Body issues the declaration of conformity required for the manufacturer to affix the CE mark.

If the manufacturer (or its EU authorized representative) is established in Italy, it must register with the Ministry of Health and communicate a description of the medical devices before it may lawfully place the devices on the Italian market.

For Class II and III medical devices, Italian law requires the manufacturer (or its EU authorized representative) to inform the Ministry of Health of certain data allowing the identification of such devices when they are put into service in Italy, including the labels and instructions for use.

2. What is the authorization process for the marketing of generic versions of these products?

According to the Italian Medicines Code, generics are granted marketing authorization in accordance with an abridged procedure when the manufacturer is able to demonstrate that the medicinal product is a generic of a reference medicine which has been authorized for at least eight years in Italy or in the EU.
According to the abridged procedure, whilst the applicant is not required to provide the results of the pre-clinical tests and clinical trials, it must file bioavailability studies in order to demonstrate bioequivalence of the generic medicine with the reference medicinal product.

Once authorized, the generic medicinal product may be placed on the market provided that ten years since the initial authorization of the originator have passed (unless an extension of such period of market protection has been granted on the basis of one of the grounds foreseen by law) .

In addition to the above, the Italian Medicines Code provides for a “hybrid” procedure in those cases where the medicinal product does not fall within the definition of “generic” or where the bioequivalence cannot be demonstrated through bioavailability studies or in case of changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration, compared with the reference medicinal product. When the “hybrid” procedure applies, the applicant is required to provide the results of the appropriate pre-clinical tests or clinical trials.

Furthermore, the Italian Medicines Code sets forth a procedure applicable to ‘biosimilars’ (i.e. biological medicinal products that, although similar to a reference biological product, do not meet the conditions to be qualified as “generic” due to differences relating to raw materials or manufacturing processes). In such case, the applicant is required to provide the results of appropriate pre-clinical tests or clinical trials relating to these conditions, whilst the results of other tests and trials from the reference medicinal product’s dossier shall not be submitted.

When none of the procedures described in the present question can be followed, the standard authorization procedure applies and the applicant is required to submit a full dossier.

3. What are the typical fees for marketing approval?

See Regulatory, Pricing and Reimbursement Overview, Question 4.

4. What is the period of authorization and the renewal process?

See Regulatory, Pricing and Reimbursement Overview, Question 5.

5. What are the requirements, if any, for post-approval pharmacovigilance?

The Italian Medicines Code imposes a number of pharmacovigilance obligations on the marketing authorization holder, including:

• appointment of a qualified person responsible for pharmacovigilance who satisfies the requirements set forth in the Italian Medicines Code;
• record of all suspected adverse reactions caused in Italy, the EU or in third countries;
• compliance with notification obligations concerning any suspected serious adverse reaction;
• sending periodical reports to AIFA concerning all information on suspected adverse reactions (Periodic Safety Update Reports);
• sending to AIFA, upon request, all data relating to the volumes of sales of the medicinal product and any available data relating to the volume of prescriptions.

AIFA is competent for pharmacovigilance compliance and, to this end, has the power to perform inspections at the marketing authorization holders’ premises and access to their records and related documents.

Violation of pharmacovigilance obligations may trigger an administrative penalty between 30,000 and 180,000 euros in addition to a fee amounting up to 1% of the revenue of the concerned medicinal product.

6. Are foreign marketing authorizations recognized?

Foreign marketing authorizations are not automatically recognized in Italy.

Without prejudice to the above, the Italian Medicines Code provides for a specific procedure to be followed in order to recognize in Italy a marketing authorization granted in another EEA country – the mutual recognition procedure. Conversely, neither the Italian Medicines Code nor Directive 2001/83/EC set out a procedure aimed at recognizing marketing authorizations issued by countries outside the EEA.

7. Are parallel imports of medicines or devices allowed?

From an intellectual property perspective, the marketing authorization holder who places or consents to the placing of the product on the market in an EEA state may not prevent that product from being imported into or marketed in another EEA state. Furthermore, the trademark owner cannot oppose the repackaging of a product imported within the EEA provided that the repackaging does not alter the original condition of the product, the product bears the name of the person who repackaged it, the repackaged product is not presented in a way which could harm the health of the consumer and the reputation of the trademark owner and this latter has been duly informed in advance of the placing on the market of the repackaged product.

Without prejudice to the above, the MA holder is entitled to make its opposition to parallel imports from outside the EEA.

a. Medicinal Products

According to the European Commission Communications 839/2003 (COM 2003/839), parallel imports of medicinal products are a legitimate form of exchange within the EU internal market.

Parallel trade can be authorized on the basis of an abridged procedure, provided that the imported product has been granted a marketing authorization in the member state of origin and it is essentially similar to a product already authorized in the member state of destination.

Ministerial Decree of 29 August 1997 sets forth the procedural requirements for parallel imports of medicinal products in Italy. The importer must file an application with the Ministry of Health including, among others, the following information:

• name of the medicinal product;
• SmPC;
• printed matter of the imported or repackaged packaging;
• data demonstrating identity of the concerned medicinal product with another that has been already authorized for marketing in Italy or, where the medicinal product is not entirely identical, all technical documentation necessary to demonstrate that the differences do not affect its quality, safety or efficacy.

In case the importer intends to repackage the medicinal product, it must perform such activity in an authorized establishment and inform the Ministry of Health.

b. Medical Devices

The parallel trade of medical devices is not regulated under Italian law, and the practice has evolved on the basis of the rules and case law for parallel imports of medicinal products. However, the existing regime has raised a number of issues since the manufacturer remains liable also for the activities attributable to the importer, unless the latter:

• repackages the medical device by adding a different brand so that the product is marketed under the importer’s name;
• makes changes to the device so that it is no longer covered by the original CE mark (e.g. the device is modified or the batch number or the manufacturer’s mark is changed).

Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – which will become fully applicable on 26 May 2020 and 26 May 2022 respectively – modify the existing regime by indicating the cases in which the importer undertakes the obligations of the manufacturer.

8. What are the restrictions on marketing practices such as gifts, sponsorships, consultancy agreements, travel and entertainment, or other incentives for healthcare organizations and individual medical practitioners?

The Italian Medicines Code prohibits pharmaceutical companies from granting, offering or promising gifts, pecuniary advantages or benefits in kind when promoting their medicinal products, unless said benefits are modest in value and of use for the professional activity carried out by the HCPs. The Italian Medicines Code, consistently with the aforesaid, also forbids HCPs from soliciting or accepting any gift or benefit. In this respect, Presidential Decree 62/2013 (“Code of Conduct for public officials”) defines a “gift or other benefit modest in value” as not exceeding 150.00 euros.

Furthermore, when organizing/sponsoring scientific congresses attended by persons qualified to prescribe or supply medicinal products, the Italian Medicines Code allows pharmaceutical companies to bear the travelling and accommodation expenses in connection therewith, provided that such hospitality:

• is not extended to any accompanying person;
• does not exceed twelve hours before and after the event;
• is appropriate for the scientific purpose of the event.

Without prejudice to the above, interactions between pharmaceutical companies and healthcare organizations/professionals are mainly regulated under Ethics Codes issued by representative bodies of the pharmaceutical industry and best practices adopted internally by the single corporations. In this respect, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) adopted a code regulating the interactions between the pharmaceutical industry and HCPs which also covers marketing practices (such as events and meetings, gifts, promotional items and fees for services).

Similarly, European standards are covered under the codes adopted by the European Federation of Pharmaceutical Industries and Associations (EFPIA), including the following:

• Code on the Promotion of Prescription-Only Medicines to, and Interactions with Healthcare Professionals (HCPs Code);
• Guidelines on principles promoting best practices in the pharmaceutical sector to ensure that all interactions with HCOs are honest, fair and also transparent;
• Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations (PO Code) to ensure that relationships with patient organizations are ethical and transparent;
• Code on Disclosure of Transfer of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations, which imposes disclosure obligations on transfers of value to HCPs and HCOs.

In line with the above trend, the Italian Trade Association for Pharmaceutical Companies (Farmindustria) adopted a code of conduct aimed at regulating interactions between pharmaceutical companies and HCPs/HCOs, providing specific requirements for gifts, hospitality, consultancy, sponsorships and grants. The Code was lastly updated in July 2019.

As for medical devices, the MedTech Europe Code of Ethical Business Practice regulates all aspects of the industry’s relationship with HCPs/HCOs with the aim of ensuring that all interactions are ethical and professional. At the national level, Confindustria Dispositivi Medici – the Italian trade association representing medical device manufacturers – recently issued its Code of Ethics. The Code covers a wide range of interactions with HCPs and HCOs, including those occurring in sponsorships of training events for health professionals, and requires member companies to ensure full transparency of all business contributions to HCPs and HCOs.

Finally, the Italian legislative framework might change in the near future due to the adoption of a new legislative decree providing for disclosure obligations on pharmaceutical companies and manufacturer of medical devices. According to the proposed decree (so-called “Italian Sunshine Act”) manufacturers and distributors of medicinal products and medical devices will be required to publish on the website of the Ministry of Health all financial transactions having an economic value higher than 50 euros when made to HCPs and of 500 euros when made to HCOs. The bill has been pending for several months and it is unclear whether it will be adopted in the near future.

9. How is the manufacturing of medicines and devices regulated and by which agencies?

a. Medicinal Products

According to the Italian Medicines Code, the manufacturing of medicinal products and biologicals – also when intended for exportation only – requires a specific authorization by AIFA. AIFA is also the competent authority for compliance with all applicable requirements.

In order to obtain a manufacturing authorization, the applicant is required to:

• specify which medicinal products and pharmaceutical forms it intends to produce or import, as well as the production or import site;
• have suitable premises, technical equipment and facilities for the production or importation of the medicinal products;
• appoint at least one qualified person.

Furthermore, the production site and relevant production and quality control personnel, including the qualified person, must be located in Italy. The authorization is issued within ninety days upon filing of the application and following an assessment carried out by AIFA on the aforementioned requirements.

Upon issuing of the manufacturing authorization, the manufacturer is required, among other things to:

• have staff compliant with the legal requirements concerning manufacture and controls;
• sell medicinal products authorized according to the applicable law and regulations;
• grant access to AIFA’s appointed inspectors for performing compliance inspections;
• comply with the principles and guidelines on good manufacturing practice for medicinal products (GMPs) provided for in the Italian Medicines Code and in the relevant EU laws and regulations;
• verify that the manufacturers, importers and distributors from whom it obtains active substances are registered with the competent authorities;
• verify the authenticity and quality of the active ingredients and excipients.

b. Medical Devices

The manufacturing of medical devices does not require a formal authorization under Italian law. However, the manufacturer is responsible for ensuring that the medical devices are compliant with the applicable health and safety requirements and have been subject to appropriate tests aimed at verifying such conformity. Furthermore, once the CE mark has been affixed, the manufacturer must communicate its registered office and the characteristics of the concerned product to the Ministry of Health.

10. Are local manufacturing requirements compatible with Good Manufacturing Practices (GMPs) as defined by the U.S. Food & Drug Administration and/or the European Medicines Agency?

Italian Medicines Code expressly requires the manufacturer to comply with the standards of good manufacturing practice for medicinal products (GMPs).

EU or Italian medical device rules do not expressly require compliance with GMPs. However, pursuant to legislative decree 46/1997, medical devices manufactured in accordance with the EU harmonised technical rules are automatically considered compliant with the essential health and safety requirements.

11. What is the inspection regime for manufacturing facilities?

a. Medicinal Products

AIFA is the authority responsible for monitoring compliance and issuing penalties in case of non-compliance with GMPs. To this end, AIFA can perform inspections, whether announced or unannounced, at production sites and can ask to Official Medicines Control Laboratory or other designated laboratories to carry out tests on samples. The whole procedure entails co-operation with EMA and other member state by sharing information about performed or planned inspections.

When, as the outcome of the inspection, results a non-compliance with the legal requirements and/or GMPs, the information is entered in the EU database and AIFA can suspend or revoke the manufacturing authorization as well as decide to close the production site.

Without prejudice to the above, failing to comply with the terms of a manufacturing authorization and/or GMPs may also constitute a criminal offence.

b. Medical Devices

The Ministry of Health is the competent authority for monitoring compliance with manufacturing requirements. This authority is therefore entitled to perform inspections at productions sites, either directly or through authorized bodies.

In case the outcome of the inspection shows that the CE mark has been applied in violation of the relevant provisions, the Ministry of Health orders the manufacturer or its authorised representative to take all appropriate measures to ensure compliance with the law within a maximum of thirty days. Should the manufacturer be found non-compliant after expiry of the thirty days term, the Ministry of Health orders the manufacturer or its authorised representative to withdraw from the market the medical devices at their own expense.

12. Are manufacturing facilities open for inspection by foreign inspectors or third-party inspectors as authorized by the FDA/EMA?

Inspections at production sites for medicinal products can only be performed by AIFA with or without the support of duly appointed third parties, such as Official Medicines Control Laboratory or other designated laboratories, for the purpose of carrying out tests on samples. However, inspections may also be carried out upon request from the European Commission, EMA or an EU member state.

With respect to medical devices, the Ministry of Health and its authorized bodies are the only authorities empowered to perform inspections at productions sites located in Italy. However, sharing of information with the European Commission is always ensured.

13. What are the requirements for storage, packaging, and handling of medicines and devices and their constituent components?

a. Medicinal Products

According to the Italian Medicines Code, the storage, packaging and handling of medicinal products and biological must follow the indications provided for in the marketing authorization dossier approved by AIFA. To this end, the marketing authorization dossier includes information as to:

• reasons for the precautionary and safety measures to be taken for the storage of the medicinal products;
• a sample of the outer and immediate packaging;
• the package informative leaflet.

The manufacturer shall ensure that all manufacturing operations of the medicinal products comply with the above-mentioned indications.

Furthermore, GMPs also provide for guidelines on the proper storing, packaging and handling of medicinal products and biologicals. The manufacturer must comply with the requirements set forth in the GMPs and is required to perform quality checks and keep proper records of the results therein. Compliance with requirements for storing, packaging and handling of medicines is monitored by AIFA.

b. Medical Devices

The manufacturer must ensure that the labeling of a medical device contains all information relevant for allowing its proper and safe use by the final user, including information on proper storage and handling. Furthermore, medical devices can only be marketed in Italy provided that they bear the CE mark, which must be affixed in a visible, readable and indelible manner on the device itself, on the sterile packaging, where possible, and on the commercial packaging, where appropriate. The CE marking must also be accompanied by the identification of the Notified Body responsible for the conformity assessment.

More generally, requirements on proper storage, packaging and handling are included in the harmonised technical rules of the EU and the corresponding implementing national rules. Fulfilling the mentioned technical standards grants the manufacturer of the medical device a presumption of compliance with the essential safety and health requirements for manufacturing and marketing of medical devices, including storing, packaging and handling. Compliance with requirements for storing, packaging and handling of medicines is monitored by the Ministry of Health.

14. What information must be included in medicine and device labeling?

a. Medicinal Products

The Italian Medicines Code sets forth the information to be provided on the labeling of medicinal products, including inter alia the following:

• the name of the medicinal product, followed by its strength and pharmaceutical form;
• whether the medicinal product is intended for babies, children or adults. In case the medicinal product contains up to three active substances and the name of the product is a fantasy name, the common name for the medicinal product shall also be included;
• the qualitative and quantitative composition in active ingredients per dosage unit, or in relation to the pharmaceutical form, per volume or weight;
• the pharmaceutical form and the contents of the package, expressed in weight, volume or dosage units;
• a list of excipients, along with their known action or effect;
• the method of administration and, if necessary, the route of administration;
• a special warning that the medicinal product must be kept away of children;
• any special warning that may be necessary, with particular reference to the adverse reactions that may be caused by the interaction of the medicinal product with alcohol or any danger in driving after taking the medicine;
• the expiry date;
• specific storage precautions, if any;
• if necessary, any specific precautions to be taken for the disposal of the unused medicinal product or waste materials derived from it, and a reference to any appropriate collection system in place;
• the name and address of the marketing authorization holder, indicated by the wording “marketing authorization holder”;
• the number of the marketing authorization;
• the batch number;
• for non-prescription medicinal products, the therapeutic indications and the main instructions for use;
• an indication of the conditions for reimbursement by the SSN.

The above information must appear on the outer packaging of the medicinal product or, if missing, on the immediate packaging. All information must be provided in Italian and must be easily readable, clearly understandable and indelible.

Furthermore, where not all information provided for in the Italian Medicines Code can be included in the outer or immediate packaging, an informative leaflet must be provided. The informative leaflet shall be drafted in compliance with the SmPC and include all information relating to the identification of the medicinal product, therapeutic indications, a list of the information needed before taking the medicinal product, the instructions for proper use, a description of the adverse reactions which may occur under normal use of the medicinal product and a reference to the expiry date provided for on the outer packaging.

AIFA is responsible for supervising and enforcing the provisions applicable to the packaging and labeling of medicinal products.

b. Medical Devices

The applicable regulatory regime requires that all necessary information for a proper and safe use of the medical device must be included in the labeling or in the instructions for use which must appear on the device itself, where possible, or on the inner or outer packaging.

The labeling must include, among other things:

• the business name and registered office of the manufacturer and the authorized representative, if the manufacturer is not established in the EU;
• the information necessary to identify the medical device and the content of the packaging;
• where appropriate, the wording ‘STERILE’;
• where applicable, the batch code;
• where appropriate, an indication of the use-by-date, expressed in year/month;
• where appropriate, an indication that the device is for single use;
• for custom-made devices, the indication “custom-made device”;
• for devices intended for clinical investigation, the indication “for clinical investigation only”;
• the specific storage and/or handling conditions;
• any specific instructions for use;
• warnings and/or precautions to be taken.

The Ministry of Health is the competent authority for assessing that the labeling or instructions for use provided by the manufacturer ensure a safe use of the product.

15. What additional information may be included in labeling and packaging?

According to the Italian Medicines Code, the outer packaging and the informative leaflet may bear signs or pictograms that help clarifying the mandatory information and additional information that are compliant with the SmPC, of use for patients and do not entail any promotional content. The above mentioned signs, pictograms and additional information require a prior authorization from AIFA.

Furthermore, the Italian Medicines Code allows the use of foreign languages on the labeling in addition to Italian provided that the information are translated correctly with no nuances that could lead to misinterpretation. The marketing authorization holder who intends to add information in a foreign language must notify AIFA and keep an official translation of the information available for inspection by the authority.

As for medical devices, any additional information that could be useful for promoting the safe and proper use of the medical device may be entered by the manufacturer.

16. What items may not be included in labeling and packaging?

As a general principle, no false or misleading information must be provided on the labeling or packaging of a medicinal product or medical device. Furthermore, information that could lead to the irrational, unsafe or improper use of the medicinal product or the medical device are forbidden.

17. What are the restrictions and requirements for the marketing and advertising of medicines and devices?

a. Medicinal Products

The main provisions on marketing and advertising of medicinal products are laid down in Articles 113 and ff. of the Italian Medicines Code.

The Italian Medicines Code provides for a broad definition of “advertising of medicinal products” which includes any information, canvassing or promotional activity aimed at encouraging the prescription, supply, sale or consumption of medicinal products.

As an exception to the above, the definition of “advertising of medicinal products” does not include:

• the labeling and package leaflet;
• the information provided in response to a specific and unsolicited request on a given medicinal product;
• factual information and reference documents relating, inter alia, to changes in packaging, warnings about side effects resulting from pharmacovigilance activity, sales catalogues and price lists, provided that they do not include any information on the medicinal product;
• information relating to human health or diseases, provided that there is no reference, even indirect, to the medicinal product.

Without prejudice to the above, advertising is only allowed for medicinal products that have been already granted a marketing authorization, provided that the promotion:

• is compliant with the information provided in the SmPC;
• encourages the rational use of the medicinal product by presenting it in an objective manner and without exaggerating its properties;
• is not misleading.

Further restrictions apply in case of advertising of medicinal products to the general public. In particular, this form of advertising:

• can concern only non-prescription medicinal products not reimbursed by the SSN;
• requires an authorization to be issued by the Ministry of Health;
• must meet the following requirements:

1. clearly present the message as an advertisement and identify the product as a medicine;
2. include the name of the medicinal product and the common name of the active ingredient;
3. include all information essential for proper use of the medicinal product;
4. include an express and clear invitation to carefully read the warnings provided for in the informative leaflet or on the outer packaging;
5. be easily readable when in written advertising.

In addition, no promotional campaign addressed to the general public shall be designed in a way that, inter alia:

• suggests that counseling or intervention of an HCP is unnecessary;
• suggests that the medicinal product is free from adverse effects;
• compares two or more medicinal products;
• suggests that the medicinal product can improve the normal state of good health of the patient or, if not used, may have detrimental effects on it;
• is mainly addressed to kids;
• includes recommendations from scientists, health professionals or people well known to the public;
• makes the medicinal product appear as a food, cosmetic or other product intended for consumers.

Within the category of medicinal products not subject to medical prescription, Italy distinguishes between OTCs and another category of non-prescription medicines, which are classified as “SOP” (Senza obbligo di prescrizione – “not subject to medical prescription”). This distinction has been of great importance until two rulings issued in 2016 and 2017 by the Italian administrative courts. Before these rulings, the promotion of SOPs to the general public was prohibited. After these judgements, the Ministry of Health started to grant authorization for the promotion to the public both of OTCs and SOPs, even with slight differences. To this extent, promotional contents concerning SOPs must be accompanied by the following message: “E’ un medicinale senza obbligo di prescrizione (SOP) che può essere consegnato solo dal farmacista. Ascolta il tuo farmacista” (“This is a medicinal product not subject to medical prescription (SOP) that must be delivered by the chemist. Listen to your chemist”). Moreover, as the SOPs must be delivered to the general public by the chemists – i.e. persons cannot have direct access to such medicines – any form of promotion that allows a direct contact between the general public and SOPs is not permitted.

Without prejudice to the above, the distribution to the public of medicinal products for promotional purposes is always forbidden.

With respect to medicinal products subject to medical prescription, advertising is only allowed when addressed to health care professionals authorized to prescribe the specific medicine. In such cases, the promotional material must:

• be filed with AIFA ten days before the distribution to HCPs;
• indicate the date of its filing with AIFA;
• include the SmPC;
• include the supply classification;
• indicate the selling price and the conditions of its reimbursement by the SSN, where applicable.

b. Medical Devices

The Medical Device Decree prohibits the advertising to the general public of medical devices subject to medical prescription or that require an HCP for their utilization. Conversely, non-prescription medical devices can be directly promoted to the public provided that an authorization by the Ministry of Health has been obtained.

In addition, Ministerial Decree of February 23, 2006 sets forth guidelines on the advertising of medical devices. To this end, the Ministry of Health can deny the authorization where it considers that the device should be subject to medical prescription or used with the assistance of a HCP, regardless of the different indications provided by the manufacturer.

18. Where can medicines and devices be sold or delivered? Can medicines and devices be sold or delivered via post?

a. Medicinal Products

As a general rule, medicinal products can be either delivered by doctors in healthcare institutions, such as public or private hospitals, or be sold by pharmacists. OTC medicinal products can also be sold by retailers authorized pursuant to Law Decree 223/2003, converted into Law 248/2006.

The Italian Medicines Code expressly prohibits the online supply of medicinal products subject to medical prescription. Conversely, non-prescription medicinal products – bot OTCs and SOPs – can be sold online to the general public by pharmacies and retailers in accordance with Law Decree 223/2003, provided that an authorization has been granted by the competent regional or local authority and that the registration with the Ministry of Health has been completed.

b. Medical Devices

Italian law imposes no specific restrictions on the delivery or sale of medical devices, except for devices subject to medical prescription or that require a doctor for their utilization.

Italian law does not provide for specific provisions regarding the online sale of medical devices. However, under the relevant EU regulation and case law, the online sale of these products cannot be prevented. In this regard, the European Court of Justice has affirmed that national laws may prohibit the online sale of medical devices only where the ban is justified by reasons relating to health protection. Consequently, the Italian legislative framework allows the online sale of medical device provided that the concerned products:

• bear the CE mark;
• do not require medical prescription or assistance of HCPs;
• are safe and intended for minor conditions;
• are intended for use for a short period of time.

Finally, Regulation (EU) 2017/745 (which will apply as of 26 May 2020) endorsed the Court of Justice approach, confirming that the online sale of medical device is fully legitimate.

19. What are the restrictions and requirements for electronic marketing and advertising via email, by Internet, social media, and other channels?

a. Medicinal Products

The general restrictions and requirements provided for by the Italian Medicines Code also apply to advertisement via email, by Internet, social media, etc.

Without prejudice to the above, the Ministry of Health issued several specific guidelines providing for stricter requirements on advertising of medicinal products on internet – particularly on social media. As an example, advertising on social media is allowed provided that comments and reactions (e.g. likes, emoticons) are disabled and that the following disclaimer is included: “The Ministry of Health only authorizes the advertising content. Any comment remain under the sole responsibility of the user, the company is not liable in relation to comments by the users”. All online promotional activities, including those with scientific content, must be notified and authorized by the Ministry of Health.

b. Medical Devices

Advertising of medical devices on the Internet, including social media and via email, must comply with the general relevant provisions laid down in the Medical Device Decree and Ministerial Decree of 23 February 2006.

Furthermore, the Ministry of Health issued guidelines on the specific requirements for advertising of medical devices on the internet and on social media. Similarly to the trend in the medicine advertising, social media promotion of medical devices is allowed provided that comments and reactions (like, emoticon) are disabled and that the following disclaimer is included: “The Ministry of Health authorizes only the advertising content. Any comment remains under the sole responsibility of the user, the company is not liable in relation to comments by the users”.

20. May medicines and devices be advertised or sold directly to consumers?

a. Medicinal Products

The Italian Medicines Code prohibits the advertisement to patients of medicinal products subject to medical prescription and/or reimbursed by the SSN.

Without prejudice to the above, medicinal products not subject to medical prescription may be directly advertised and sold to patients, provided that all requirements set forth in the Italian Medicines Code are complied with.

Pharmacies may sell to patients all prescription and non-prescription medicines except those meant for delivery by doctors in healthcare institutions (such as hospitals) only.

With reference to the medicinal products not subject to medical prescription, the Italian Medicines Code establishes that patients can have direct access to OTCs only, whilst SOPs must be hand-delivered by the pharmacist.

As per the medicines subject to medical prescription, these products can be sold by the pharmacist only upon delivery of the prescription by the patient.

b. Medical Devices

Non-prescription medical devices can be advertised directly to consumers provided that an authorization has been granted by the Ministry of Health and that requirements set forth in the Medical Device Decree and Ministerial Decree of 23 February 2006 are complied with.

Furthermore, medical devices can be generally sold directly to consumers, unless medical intervention or assistance is required for their use.

21. How is compliance monitored?

a. Medicinal Products

The regulatory authorities responsible for monitoring compliance with provisions on advertising are the Ministry of Health and AIFA.

In order to obtain authorization for advertising of medicinal products, the holder of the marketing authorization must submit all relevant promotional materials to the authorities for their approval. Following the authorization, the advertising materials cannot be modified by the marketing authorization holder unless notified and approved by the same authorities.

b. Medical Devices

The Ministry of Health is in charge for monitoring compliance of the advertising of medical devices with relevant laws.

Similarly to the regulations of advertising in medicines, the manufacturer must submit all relevant promotional materials to the Ministry of Health for its approval and authorization. Afterwards, all amendments to the notified promotional materials must be submitted to the same authorities for authorization.

22. What are the potential penalties for noncompliance?

a. Medicinal Products

The Italian Medicines Code establishes that non-compliance with the provisions contained therein governing the advertisement of medicinal products triggers an administrative pecuniary fee ranging from 2,600 to 15,600 euros.

Without prejudice to the above, the Ministry of Health can impose additional sanctions for the violation of the provisions concerning the advertising of non-prescriptions medicine. In particular, the Ministry of Health can:

• order the marketing authorization holder to stop the advertising campaign;
• order the dissemination, at the marketing authorization holder’s expense, of a statement to correct and clarify the content of the advertising.

AIFA is the authority in charge for the advertising to HCPs of medicines subject to medical prescription. When the marketing authorization holder is found not compliant with the relevant provisions, AIFA can:

• order the marketing authorization holder to end or suspend the promotional activity;
• order the dissemination, at the marketing authorization holder’s expense, of a statement to correct and clarify the content of the advertising, following indications provided directly by AIFA.

Without prejudice to the above, non-compliance with the provisions on advertising of medicinal products may entail further administrative sanctions.

b. Medical Devices

According to Royal Decree 1265/1934, the advertisement of medical devices in absence of the required authorization triggers an administrative pecuniary fee ranging from 2,582.28 euros to 15,493.71 euros. In addition, in case of violation of the relevant provisions governing the promotion of medical devices, the Ministry of Health can:

• order to end the advertising campaign;
• order the dissemination of a statement to correct and clarify the content of the advertising.

Without prejudice to the above, non-compliance with the provisions on advertising of medical devices may entail further administrative sanctions.