Request of authorisation for on-line selling of medicines in Italy

The Italian Ministry of Health made available on its official website the guidelines on how to apply for the authorisation to sell medicines on-line.

Under the current legislation, online selling of medicines requiring medical prescription is forbidden in Italy. Only medicines that do not require medical prescription (the so-called SOP, acronym of the Italian “Senza Obbligo di Prescrizione”) can be sold online. This category includes the so-called OTC (over the counter). [1]

OTCs must bear an identification code that let the customers identify them. Moreover, the external package of both OTCs and SOPs must display the statement “Medicine without prescription”.

All the OTCs and SOPs must be marked with the following identification sticker, printed or glued in a prominent position on all packages (through this label, the consumer can easily identify the type of the medicinal product exposed on the counter).

Only pharmacies and shops, like drugstores and "health corner" of large retailers (provided by art. 5, subparagraph 1, of Decree Law n. 223 dated 4 July 2006), and already authorised to sell medicines in the territory can be authorised to sell online. By contrast, wholesalers are not allowed to sell online. [2]

Violation of the above mentioned legal requirements constitutes a case of illegal sale of medicines outside of authorized channels. [3]

In Italy, the authorization for selling medicines on the internet is issued by Region or Autonomous Province, or by competent authorities identified by the Region or the Autonomous Province. A prior notification of the following information (to be promptly modified in case of variations) is needed:

• name, VAT number and full address of logistics site;
• starting date of the sale at a distance to the public of medicinal products through the Internet;
• address of the website used for that purpose and any information needed for the identification of the site.

Once the authorisation is obtained (since the on-line selling is forbidden before the registration in the list of authorized entities), the owner of the pharmacy/retail must:

i) registrer in the list of authorized entities that can sell medicines via the Internet, by completing the online application form.

ii) acquire digital copy of the national identification logo (Decree of General manager of medical devices and pharmaceutical services, published in Official gazette of July 6th 2015). The national logo shall be necessarily prominently displayed on every page of the website of the pharmacy or retail, and shall be linked to the corresponding pharmacy/retail’s entry on the Ministry of Health website.

Once the application form is compiled, it must be sent by e-mail to the address dgfdm@postacert.sanita.it, attaching a copy of the identification document of the owner and a copy of the authorisation for the sale via the Internet released by the competent authority.

The Ministry of Health shall verify the accuracy of the data acquired and then, in case of positive outcome, shall register the applicant in the list of authorised entities for the sale of medicines via the Internet. The Ministry also send to the authorised pharmacy or retail – via certified email – a digital non-transferable copy of the national logo with the hyperlink to the list of the authorised entities for the sale of medicines via the Internet, that has to be linked to the logo itself when inserted in the website. The authorised entities are required to report, within thirty days, any change in the conditions which allowed the granting, failing which the revocation of the authorisation.

The national identification logo [4] must be displayed, clearly visible, on each page of the website of the pharmacy/retail on which the medicines are sold. To avoid possible misunderstandings, the logo shall not be displayed on pages selling products other than medicines without prescription (such as medical devices, food supplements, cosmetics, etc.).

The common logo is copyrighted, that means that the use of it does not confer any intellectual property or other proprietary right on the same (as per Decree of General manager of medical devices and pharmaceutical services, dated 6 July 2015). The applicant is allowed to use it only for the purposes provided by law. The authorised subjects who received the logo are personally responsible for any violation related to improper use as per the legislation in force (see Legislative Decree n. 219 dated 24 April 2006, art. 112-quater) and thus are subject, in the case of violations, to administrative and criminal sanctions.

The “common logo” – used for all the e-pharmacies of the European Union which operates legally – is a registered trademark [5] characterised by specific graphical and verbal elements (“Composite Mark”), which allows also the identification of the Member State in which is based the entity that sells at the distance to the public.

The presence of the national identification logo on the website of an e-pharmacy has the aim to guarantee the legality of the purchase and the safety (quality) of the products offered, since every step of the distribution chain is strictly controlled, in order to guarantee both the seller and, most of all, the user-consumer.

In this regard it’s easy to verify the reliability of the information given on the website: it’s sufficient to click on the logo to be automatically redirected to the website of the Ministry of Health, where it is possible to verify that the on-line seller is registered in the list of the authorised retailers. [6]

It should be noted that the Ministry of Health has repeatedly drawn attention to the importance of respecting professional duties and to criminal sanctions as per art. 147, subparagraphs 4-bis and 4-ter of Legislative Decree n. 219/2006, involving serious consequences for transgressors. [7]

At the same time, the Ministry of Health – supported by the NAS - Comando dei Carabinieri per la Tutela della Salute - may, for justified reasons and also on an urgent basis, order cessation of the illegal trade practices concerning the sale of medicines online.

Notes:

[1] The Over The Counter medicines are self-medication drugs, that don’t need a medical prescription for the purchase. These medicines can be freely purchased in pharmacy, drugstores and in the appropriate retail spaces within stores and supermarkets. The OTC are a sub-category of the so-called SOP (without prescription medicines). OTC medicines can be advertised while SOP can’t. For this reason, the OTCs may be exposed on the counter of the pharmacy, while SOPs are accessible to citizens only through pharmacists. Both OTCs and SOPs belongs to group C, namely medicines to be paid entirely by patients. They can be chosen by the citizens, recommended by pharmacists or by family doctor. It should be noted that their use is not risk free: a misuse, in fact, may cause undesirable and harmful effects.

[2] The pharmacist, or the cooperative of pharmacists, that own also an authorisation to the distribution, can sell on-line to the public only SOPs purchased by the pharmacy of which he’s holder and by means of its unique code, therefore aimed to the sale to the public, and only under the authorisation of the pharmacy, and therefore intended for sale to the public, stored in the pharmacy warehouse. The pharmacist is the only responsible for the sale of medicines and must verify, as professional obligation, the integrity of the medicines he/she sells, and for the proper storage of the medicine, for verifying the correspondence between the ordered and shipped. The pharmacist must take charge of the medicines, by taking possession of them before shipping them to the client. The distributor’s failure to comply with the above mentioned obligations leads to the violation of Art. 104, subparagraph 1, letter c of Legislative Decree 219/2006, with the consequent application of the administrative sanction as per art. 148, subparagraph 13, without prejudice to the criminal penalties that may apply.

[3] Any conduct, on the part of a pharmacy or shop’s holder selling medicines ex art. 5 L.D. 223/2006, which infringes current legal provisions, leads to the violation of Art. 122 of Royal Decree 1265/1934, while subjects other than pharmacies and shops, that sell medicines on the internet as per art. 5, are punished in accordance with Art. 147, subparagraph 4-ter. The sale on the internet of SOP medicines without the specific authorisation which allows to sell through a specific website is a conduct punishable under the abovementioned art. 122, subparagraph 4. Measures provided in paragraphs 3, 4 and 6 of art. 142-quinques of L.D. 219/2006 still stand.

[4] The use of the common logo for the e-pharmacies was introduced by Directive 2011/62/EU, that modified Directive 2001/83/EC dated 6 November 2001, on the Community code relating to medicinal products for human use, directive transposed in Italy with Legislative Decree n. 17 dated 19 February 2014, that modified the Legislative Degree n. 219 dated 24 April 2006.

[5] The TradeMark has been added in Annex to the Implementing Regulation (EU) n. 699/2014 of the Commission and was licensed to Italy with the Licence Agreement Online Pharmacies logo, signed between EU and Italy on March 4th 2015.

[6] With reference to the legal obligations related to the logo, it should be noted that the provision expressly prohibits: a) to rent, to lease, to assign or to transfer the rights related to the common logo and to the national identification logo, to third parties; b) to modify the layout of the common logo or the national logo, as well as to create, to develop and/or to use derivations or variations based on any part thereof, with the exception of proportionally increase or decrease the size of the national logo; c) the development and the acquisition of any right of registered trademark associated with the institutional logo of the European Commission, the European emblem, the national identification logo and each derivation of the same, such as any national, European or international registered trademarks, corporate images, trade name, service marks, symbols, slogans, emblems, logos, designs that incorporate, fully or partially, the national identification logo; d) to combine the national identification logo or any part thereof with any other object that may mislead third parties in relation to the meaning and appearance of the logo itself; e) to use the national identification logo for activities that are beyond the scope established by Legislative Decree n. 219 dated 24 April 2006.

[7] In particular, the law sets up to one year’s imprisonement and a fine of two thousand to ten thousand euro, for those who sell on the Internet medicinal products requiring medical prescription; imprisonment from six months to two years and a fine of three thousand to eighteen thousand euro for those who sells medicinal products without any authorisation.