New developments for veterinary medicines
On 3 January 2024, the Legislative Decree of the Ministry of Health no. 218 of 7 December 2023 was published in the Official Journal, laying out the “Compliance of national norms with the provisions of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC, as per article 17 of Law 4 August 2022, no. 127”.
This Decree, becoming effective on 18 January 2024, has established the rules required to adjust the national legal system to the provisions of the European Regulation and includes some clarifications by the Ministry of Health on specific issues regarding veterinary medicinal products.
The figure of the depository and other news
Among the novelties, the definition of “depository”, a figure that was not contemplated by the law in the past, now defined as “the subject holding veterinary medicinal products for future marketing based on depository agreements signed with marketing authorisation holders of veterinary medicinal products or with their representatives”.
Another novelty is the possibility for fractionable multiple packs to be granted authorisation. The issue was anticipated and discussed during the latest “Infoday” on veterinary medicinal products organised by the Ministry of Health last December.
The goal is to supply only the dose required for the specific therapy, avoiding any waste of veterinary medicines and limiting any potential abuse of drugs if not prescribed by the veterinary.
For this special category of packs, the marketing authorisation holder should make sure that these packs contain the same number of package leaflets as the number of the units that can be dispensed individually or any other electronic support that can be used for each single unit.
It is also possible to apply for the authorisation of homeopathic veterinary medicinal products. However, in case there is no registered homeopathic veterinary medicines, and the doctor’s therapeutic choice provides for the use of homeopathic medicines, a homeopathic medicinal product registered for human use can be prescribed.
In case the homeopathic medicine for human use is administered to a food-producing animal, the withdrawal period is 0 days if specific requirements are met.
Regulations on the sale of veterinary medicines
Regarding the sale of veterinary medicinal products, of course the obligation to be sold in pharmacies by pharmacists enrolled in professional boards remains unvaried, however there can be some exceptions.
In fact, the Decree provides for that retail sale of veterinary medicines with antiparasitic or disinfectant action for external use and for oral use can also take place in shops other than pharmacies, provided that there is no obligation of a veterinary medical prescription.
Moreover, only for non-prescription veterinary medicinal products, remote retail sale and wholesale distribution and sale in shops other than pharmacies are also allowed.
Another issue is the one related to veterinary prescriptions, that should be in electronic format via the traceability information system defined by the Legislative Decree.
The validity of the prescription as of the date of issue is established as follows:
- six months for repeatable veterinary prescriptions to be used for a maximum of 10 times during this period;
- thirty days for non-repeatable veterinary prescriptions, for veterinary prescriptions to buy medicine stocks and for veterinary prescriptions of medicinal products whose use is not provided for by the marketing authorisation.
Promotion of Veterinary Medicines
For promotion, the need to apply for an authorisation is confirmed for advertisements addressed to the public, only for medicinal product not subject to veterinary prescription.
Samples of veterinary medicines cannot be distributed to public for promotional purposes.
The delivery of free samples is only allowed to veterinary doctors by the marketing authorisation holder and within limits and by methods indicated in the Decree.
Written on 17/01/2024 by Federica Montozzi
