June 4, 2019

Substitutability of veterinary medicines: this is now also possible through the use of parallel imports

This is a period of profound changes in the veterinary medicines sector. After the publication of the Regulation (EU) 2019/6 on veterinary medicinal products repealing Directive 2001/82/EC, in the Official Journal, and the complete rewriting of the rules governing this sector, in January 2019, there have been some interesting national innovations in regard to the dispensing of veterinary medicines. Some examples may be found in the introduction to the mandatory electronic veterinary prescriptions and in its clarifications, which are provided by the Ministry of Health, on the possibility for the pharmacist to replace those medicines that are prescribed by the veterinarian.

The above-mentioned Regulation demands that the Member States adopt the regulatory framework governing the retail sale of veterinary medicinal products. For this reason, even after the Regulation becomes applicable (on January 28, 2022), differences between Member States may remain in this area. Consequently, operators may have to pay particular attention to these possible divergences.

Electronic veterinary prescription

As a result of the Decree of the Ministry of Health, dated February 8, 2019, coming into force, electronic veterinary prescriptions became mandatory from April 16, 2019, and these have replaced the traditional printed ones.

The mentioned Decree of the Ministry of Health implemented Section 3 of Law no. 167 of November 20, 2017, which set out the introduction of electronic prescriptions for veterinary medicines and medicated feed’s traceability reasons. This provision clarified that the electronic veterinary prescription serves the pharmaco-surveillance national information system and is applicable to the whole medicinal product and medicated feed cycle. This allows the entire lifecycle of these products to be monitored, from the time that the prescription is written until the recording of the information related to the treatments undertaken.

With the explanatory note, dated April 26, 2019, the Ministry of Health reminded the interested operators of the improvement to the assistance that is provided by the National Service Centre, c/o Izams, and the existence of a manual relating to the Pharmacovigilance Information System, which is available on the Ministry Portal, and which contains practical advice on the issuing of electronic prescriptions.

The Health Ministry’s explanatory note on the substitution of medicines

On April 19, 2019, the Ministry of Health provided useful clarifications in a specific explanatory note with regard to the possibility of a pharmacist replacing the prescribed veterinary medicines. This possibility is established by Section 78 of Legislative Decree no. 193/2006, according to which the pharmacist may replace the prescribed veterinary medicinal product only in two specific cases.

The first case involves the possibility for the pharmacist to replace the prescribed medicine with a generic one when it is quantitatively and qualitatively identical to that prescribed, and when it is more economically advantageous to the purchaser. The second case concerns the eventuality in which there is an urgency in starting treatment, but the medicine is not immediately available. In this case, the prescribed veterinary medicinal product may be replaced by a similar one, provided that the veterinarian specifically consents.

The substitution of a medicine with another imported parallel one

With the explanatory note dated April 19, 2019, the Ministry of Health evaluated the opportunity for the replacement of a veterinary medicine in situations that are different from those provided in Section 78 of the aforementioned Legislative Decree. Specifically, the Ministry expressly provided for the possibility that a pharmacist could replace a prescribed medicine with a parallel veterinary medicine that is imported,  and which has been purchased in a Member State, that is then authorized in Italy, re-labelled and sold on the Italian market.

This is allowed on the condition that the imported medicine is more economically advantageous, while veterinary consent is not required. It would thus seem that the Ministry of Health has extended the scope of the first case of veterinary medicine’s substitutability, treating the parallel imported medicines as generic ones.

On the other hand, the replacement of a prescribed medicine with a cheaper one with the same pharmaceutical content, but with a different dosage, is still prohibited.

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