+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


12° Info Day – Veterinary medicines

As every year, the Ministry of Health has met the actors involved in the manufacturing of veterinary medicinal products, dedicating 2 days to the information on veterinary products.

This is the 12th edition of this event: there were interventions by ministry officers as well as representatives of MA holders and manufacturing sites of veterinary medicinal products. Such participation has allowed the sharing of issues and needs by all concerned parties.

There has been much work done as well as many goals achieved.

A further workload originated from the Brexit. Within 30th March 2019 all procedures shall be transferred to the Competent Authorities of the EU Member States. A RMS switch is therefore ongoing, currently completed for 63% of the veterinary drugs.

As of next 1st January, the electronic prescription will become mandatory: this will improve the traceability of veterinary medicines and medicated feeds. It should be stressed that for medicines containing narcotics the Italian Presidential Decree will still be in force as well as the paper prescriptions, but they will also be monitored.

Another goal achieved is the publication in the Official Gazette of the ministry decree on veterinary doctors working for companies. The decree defines the tasks, responsibilities and requirements of this figure.

A further constant commitment of the Ministry of Health is to act in view of the one health approach in the field of the antibiotic resistance. To support this activity, the Ministry has published the sale data of veterinary medicines containing antimicrobial agents as a precious tool to assess the use of these products.

Within short, the new Regulation on medicinal products will be also published. This should become effective in 2022.

As of the draft law of September 2014, the drafting of the text is now completed, but further administrative work will be necessary to draft the delegated acts.

The novelties include the inclusion of autogenous vaccines, currently regulated by a specific norm, inside the regulation.

Greater attention is also dedicated to veterinary medicinal products intended for minor species and with minor use (MUMS) for which there is no specific juridical definition, while the new regulation introduces the definition of “limited market” for minor uses and species.

The Italian commitment to improve the CESP (Common European Submission Portal) was also stressed, with the aim of using it for national procedures as well.

Another activity where Italy is involved is related to the project SPOR: a telematic project by EMA that is part of a wider scope of creating a European database to have univocal and standardised data for the common European database.

Finally, an update on the Ministry portal with the publication of the sheets on how to communicate non essential changes. The sheet for the request of authorisation of essential changes was already present.

It was pointed out that some companies find difficult to classify the changes when they are not included in the list of non essential changes; however the Ministry underlined that all communications and requests of authorisation received so far were classified correctly.