Legal & Regulatory > Italy > Traditional Medicines and OTC Products

The ins and outs of traditional medicines and OTC products 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 are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?

a. Herbal Medicinal Products

The Italian Medicines Code provides for an abridged procedure for the marketing authorization of herbal medicinal products, provided that:

• they are intended and designed for use without the supervision of HCPs for diagnostic purposes or for prescription or monitoring of treatment;
• they are exclusively for administration in accordance with a specified strength and posology;
• they are an oral, external and/or inhalation preparation;
• a thirty-years period of traditional use, including at least fifteen years within the EU has elapsed;
• they have sufficient data on traditional use, particularly demonstrating that they are not hazardous in the normal conditions of use and the pharmacological effects or efficacy are plausible on the basis of experience and long-standing use.

If the above conditions are met, the applicant can file a simplified dossier with AIFA. In this case, results of pre-clinical tests and clinical trials, as well as full SmPC are not required, but the application dossier must in any case include, inter alia, the following information:

• pharmaceutical tests;
• bibliographical data or an expert report demonstrating that the medicinal product has been of traditional use for at least thirty years before the date of the application, including at least fifteen years in the EU.

Finally, GMPs on medicinal products also apply to the manufacturing of herbal medicinal products.

b. Homeopathic Medicinal Products

Homeopathic products are officially recognized as medicines and are therefore subject to the provisions contained in the Italian Medicines Code. However, the Italian Medicines Code considers homeopathic to be of no therapeutic effect and establishes an abridged authorization procedure for these products, provided that:

• they are administered orally or externally;
• they do not claim any therapeutic effect;
• there is a sufficient degree of dilution to guarantee the safety of the medicinal product.

Without prejudice to the above, the majority of the homeopathic products currently available on the Italian market have not yet been granted a marketing authorization, as they benefit from the application of transitional provisions concerning all the homeopathic products that were placed on the Italian market before June 1995. The transitional period, originally planned to terminate on 31 December 1997, is still in force and currently expected to terminate on 31 December 2019.

After such date, unless a further extension of the transitional period is approved, pharmaceutical companies will be able to commercialize only the homeopathic products with a marketing authorization granted either with the abridged procedure mentioned above or the standard (i.e. full dossier) procedure.

The labelling and, where appropriate, the package insert for the homeopathic medicinal products shall bear, among other, the following information:

• clear mention of the words “homeopathic medicinal product” followed by “without any approved therapeutic indications”;
• scientific name of the stock(s);
• method of administration;
• mention of the words “not reimbursed by the SSN”.

2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?

a. Herbal Medicinal Products

Advertising of herbal medicinal products must comply with the general provisions on advertising of medicinal products set forth in the Italian Medicines Code (see under Chapter 3, questions 17, 19 and 20 above).

Furthermore, any form of advertising for traditional herbal medicinal products registered in the EU must include the following wording: “traditional herbal medicinal product for use according to specific indications exclusively based on long-standing use”.

b. Homeopathic Medicinal Products

Advertising to the general public of homeopathic medicinal products that benefit from the transitional period is prohibited.

Advertisement of homeopathic products that benefit from the abridged authorization procedure can refer only to the information included in the leaflet.

3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?

a. Herbal Medicinal Products

Herbal medicinal products must comply with the same requirements generally provided for medicinal products under the Italian Medicines Code (see under Chapter 3, questions 17, 19 and 20 above). To this end, advertising and marketing claims cannot:

• suggest that counseling or intervention by doctors is unnecessary;
• suggest that the medicinal product is free of adverse effects;
• compare two or more medicinal products;
• be mainly addressed to kids;
• suggest 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;
• include recommendations from scientists, health professionals or people well known to the public;
• make the medicinal product appear as a food, cosmetic product or other product intended for consumers.

b. Homeopathic Medicinal Products

Advertising to the general public of homeopathic medicinal products that benefit from the transitional period is prohibited. With reference to the promotion activity addressed to HCPs, it can include only documentation from the European Pharmacopoeia or the homeopathic/anthroposophical literature concerning posology and areas of application.

Advertisement of homeopathic products that benefit from the abridged authorization procedure can refer only to the information included in the leaflet.

4. What are the regulatory requirements for over-the-counter (non-prescription) medications?

Over-the-counter medicinal products must comply with the same requirements and follow the same procedural paths for authorization generally provided for other medicinal products (see Regulatory, Pricing and Reimbursement Overview, Questions 2 and 3, and Marketing, Manufacturing, Packaging & Labeling, Advertising, Questions 1 and 2).

5. Are there any limitations on locations or channels through which OTC products may be sold?

OTC medicinal products can be sold both by pharmacists and retailers authorized pursuant to Law Decree 223/2003, converted into Law 248/2006. Furthermore, OTC can also be sold online provided that the requirements set forth by the Italian Medicines Code and the guidelines issued by the Ministry of Health are met (see Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 18).

6. What health, advertising, and marketing claims may be made for OTC products?

OTC products must comply with the same requirements generally provided for medicinal products under the Italian Medicines Code (see Marketing, Manufacturing, Packaging & Labeling, Advertising, Question 17).

7. Can OTC products be marketed or advertised directly to the public?

OTC products can be marketed and advertised directly to the public provided that the requirements generally applicable to medicinal products, including stricter requirements for advertising on social media, are met (see Marketing, Manufacturing, Packaging & Labeling, Advertising, Questions 17, 19 and 20).

Furthermore, according to Law Decree 223/2003, authorized retailers can apply discounts on the price of OTCs, provided that the discount is clearly and legibly displayed to the patients and is made available to all purchasers. In any case, prize contests and below cost selling are forbidden.

8. What is the mechanism by which a prescription-only product can be converted to an OTC product?

Upon granting the marketing authorization, AIFA also determines the classification for the dispensing of the concerned medicinal product. For the purpose of this classification, although the Italian Medicines Code provides for several categories and sub-categories, the main distinction is between prescription-only medicines and non-prescription medicines. OTCs are classified as medicinal products not subject to medical prescription.

Medicinal products, including prescription-only medicines, can be reclassified, and potentially converted into OTCs, following an assessment by AIFA.

The Italian Medicines Code requires AIFA to publish in the Italian Official Journal – by February of each year – the list including all the medicinal products which have been granted a marketing authorization and their classification for the dispensing. In addition, AIFA must notify annually to the European Commission and the other member states the amendments to the afore-mentioned list concerning prescription-only medicines, specifying their classification.

9. What are the requirements for the importation of either traditional medicines or OTC products?

Imports of traditional medicines and OTCs must comply with the same requirements generally provided for imports of medicinal products (see Marketing, Manufacturing, Packaging & Labeling, Advertising, Questions 7).