Veterinary Medicines In Italy: What's New?
| Published date | 22 January 2024 |
| Subject Matter | Media, Telecoms, IT, Entertainment, Food, Drugs, Healthcare, Life Sciences, Advertising, Marketing & Branding, Food and Drugs Law |
| Law Firm | Osborne Clarke |
| Author | Osborne Clarke |
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.
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...
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