Transparency List for generics is published and new legislation harmonising EU laws on veterinary medical products with national law is shortly to come into force.
For the first time, the Italian Ministry of Health has published a Transparency List for generic veterinary medicinal products. In addition to this, in a few days a legislative decree adapting Italian legislation to the provisions of Regulation (EU) 2019/6 will enter into force.
The Transparency List
On 15 December 2023, the Ministry of Health published a list of generic veterinary medicinal products authorised for marketing in Italy and their reference veterinary medicinal products.
The aim is to address temporary drug shortages and reduce the cost of medicines. Unlike medicines for human use, veterinary drugs are not reimbursable by the National Health Service. Therefore this is not a measure to benefit the public coffers, but rather to support people incurring (substantial) costs in caring for their pets.
The list, prepared by the ministry with the support of external consultants, contains approximately 3,000 veterinary medicinal products authorised in Italy. It is intended to allow the substitution of an originator product with its generic counterpart, as well as between different generics, and certain authorised "hybrid" medicinal products.
The list is available for consultation for holders of marketing authorisations (MA), who will be able to report errors or requests for additions by 31 January 2024. It will then be finalised and published with monthly updates on the ministry's institutional website.
Regulation (UE) 2019/6
Since 28 January 2022, Regulation (EU) 2019/6 of the European Parliament and of the Council dated 11 December 2018 on veterinary medicinal products, repealing Directive 2001/82/EC, has been applicable within the European Union.
Regulation (EU) 2019/6, aimed at harmonising the sector, has essentially:
- introduced new provisions on procedures for authorising the manufacture, placing on the market and distribution of veterinary medicinal products and active substances;
- provided guidelines on their retailing, prescription, use and advertising; and
- introduced new database systems (that is, the Union medicinal products database, the database of manufacturers and wholesale distributors, the pharmacovigilance database).
Although the regulation is immediately applicable in Member
States, a national measure was necessary both to regulate those
aspects left to national regulation and to harmonise European rules
with existing national ones.
Legislative Decree n. 218/2023
On 18 January 2024, Legislative Decree no. 218 dated 7 December 2023, published in the Official Journal on 3 January 2024, comes into force. This decree – composed of 46 articles and 5 annexes – adapts and aligns national legislation with Regulation (EU) 2019/6 and repeals Legislative Decree no. 193/2006, which had transposed Directive 2001/82/EC and which had, to date, governed the matter.
The decree introduces the definition of "generic veterinary medicinal product" for the purposes of substitution of medicines by pharmacists.
It also defines the role of the Ministry of Health in authorising clinical trials, MA applications, the Summary of Products Characteristics, label and package leaflet. The ministry will classify medicinal products subject to veterinary prescription, issue manufacturing authorisations and certificates of good manufacturing practice, register import and manufacturing activities of active substances, and operate databases (of Union medicinal products, Union pharmacovigilance data and manufacturing and wholesale distribution). It will also publish on its website the list of originator and generic veterinary medicinal products, and the measures to block access to illegal online sales sites for veterinary medicinal products as well as carrying out controls and inspections and to impose sanctions.
The decree provides for the registration of homeopathic veterinary medicinal products with the Ministry of Health instead of the MA. It interconnects the national pharmacovigilance system with the Union pharmacovigilance system and strengthens collaboration in the management of reports.
The decree provides that authorisations for the wholesale distribution and direct sale of veterinary medicinal products are issued by the competent autonomous regions/provinces and defines the arrangements for retail and direct sales, through other shops and at a distance.
It also allows pharmacists and veterinary surgeons to dispense individual portions of a veterinary medicinal product necessary for the prescribed treatment and provides that the veterinary prescription is only in electronic format, has a duration of six months if a repeat prescription and 30 days if non-repeat (paper prescriptions survive only for certain narcotic prescriptions). It regulates the use of antimicrobial medicines and the conscious use of antibiotics, regulates stocks and inventories of medicines and regulates in detail the system of controls and sanctions.
Advertising of veterinary medicinal products
The decree:
- provides that advertising non-prescription veterinary medicinal products must be authorised by the Ministry of Health;
- opens up the possibility of advertising prescription-only veterinary medicines, subject to procedures to be defined by a future decree of the Ministry of Health; and
- regulates the advertising of immunological products for professional breeders.
Osborne Clarke comment
The recent regulatory interventions on veterinary medicinal products in Italy, including its first transparency list, constitute an important step towards ensuring compliance with the general principles set by the European legislator in this field.
In particular, the intention was above all to adapt the sector to scientific progress, strengthen the internal market, guarantee the availability of veterinary medicinal products (including by allowing fractional dispensing) and encourage savings for pet owners. The primary objective is to preserve the high level of protection of animal health and welfare, the environment and to maintain public health.
These legislative interventions confirm the importance of the veterinary medicines sector, where the key players are also subject to the obligations of the Sunshine Act, intended to make relations between companies and entities operating in the human and veterinary health sectors transparent (see our in-depth study here).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
