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What and how to publish in the Italian Official Journal

The Official Journal of the Italian Republic is an essential tool in the pharmaceutical sphere: in fact, any authorisation, change, variation, cancellation or revocation regarding a medicinal product marketed in Italy should go through the publication in the Official Journal in order to be considered as valid. Actually, the date of publication in the Official Journal becomes a reference for the entering into force of the decree itself (either the day of the publication or the following day).

Most decrees requiring a publication in the Official Journal to become effective are published by the Italian Medicine Agency; however simple changes, such as type I variations, and any change to the price of medicinal products, are managed by the MA holder and are published in Part II of the Official Journal, the so called “Foglio delle Inserzioni” (postings sheet).

What should be done, then, to publish these postings in the Official Journal?

The first thing to know is that all publications are managed by the IPZS (Istituto Poligrafico e Zecca dello Stato, Polygraphic Institute and National Mint), that takes care of collecting, formatting and publishing, both in paper and on line, all decrees and postings requiring to be published in the Official Journal.

As for the postings, the texts to be published can be transmitted directly to the editorial staff of the Official Journal, both in paper copy and on line. However, the easier way to proceed to the publication is to avail oneself of a concessionaire for the telematic collection of the postings, forty-ish bookshops and authorised agencies scattered all over Italy.

These, along with transmitting the publication to the Official Journal, are also able to provide support for the preparation of the text, calculating with accuracy the fees to be paid to the IPZS – that vary depending on the number of characters transmitted – but above all this will be able to manage the application of the strict norms regulating the publication.

In fact, together with a set of general rules on the number of lines and characters as well as the ways to report specific indications or numbers, the transmission of the postings to the editorial staff of the Official Journal should comply with specific typographic and editorial rules to ensure the readability of the posting and avoid any sanctions.

Authorised agencies, being familiar with such rules, can advance an estimate of the publication costs, prepare the relevant text (applying the rules also with the purpose of saving costs for the posting company), transmit the publication and manage the whole procedure up to the effective availability of the number of the Official Journal containing the publication of interest.

How long does the publication in the Official Journal take?

Telematic publications in Part II are usually managed in 3 days instead of 5, as expected for the usual procedure. They are published three times a week: on Tuesdays, Thursdays and Saturdays.

Requesting the publication is simple: agencies usually require the sending of the posting via e-mail, including the address for the shipment of the paper format of the Journal. Di Renzo Regulatory Affairs replies in a few hours with a detailed quotation and, once this has been accepted, the client is also informed about the date and number of the Official Journal where the posting is going to be published.

This is, therefore, a way to proceed allowing companies to schedule their publication activity at best and to obtain the documentation required to carry out their activities at known time points.

Written by: Maria Pia Felici

Foto di StartupStockPhotos da Pixabay