The operational indications from the Ministry of Health on the activities of pharmacists relating to veterinary drugs. The question of the substitutability of the prescribed medicine with a generic.
With the entry into force of the new code on veterinary drugs, there are many measures that have changed the reference discipline and the rules for the sector. However, there is no shortage of interpretative doubts among stakeholders regarding their application and a second tranche of operational indications has arrived from the Ministry of Health to clarify some aspects, with repercussions also on the activities of pharmacists.
Veterinary drugs and replacement: timing clarified. Transitional regime foreseen
Among the innovations that have found a regulatory redefinition with the entry into force of Legislative Decree 218/2023 – which adapts national legislation to the provisions of European Regulation 2019/6 and repeals the previous 2006 Code – there is the simplification of the replacement of the veterinary medicinal product by the pharmacist. As expected, the pharmacist informs the user, before the sale, of the possibility of using a generic or equivalent drug when this is more economically convenient or if the prescribed drug is not available in the distribution channel.
Equivalent drug means a veterinary drug, different from a biological or immunological medicinal product, having the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the prescribed medicinal product, authorized for the same indication with identical dosage for the same target animal species. of the prescription and, in the case of animals bred for the production of food for human use, the same waiting times. The new wording clarified the specification relating to the equivalent better and effectively canceled the obligation for consent from the veterinarian – even if the lack of regularization of the consent from the veterinary doctor was equivalent to acceptance of the request.
A further step in the simplification process is the publication by the Ministry of Health and the updating on its institutional website of the list of reference veterinary medicines and generic medicines that are authorized for marketing in Italy. This transparency list, on which the group headed by the General Directorate of Veterinary Medicines is working, with the collaboration of Federfarma, saw a public consultation phase through which the MA holders had the opportunity to provide additions or observations by January 31st. Once this step has been completed, with the analysis of the information received, the document can be officially published on the portal.
However, regarding the timing of implementation of the substitution measure, a clarification arrived in a ministerial circular yesterday, which was necessary to respond to the interpretative doubts of stakeholders. Specifically, the Ministry clarifies that until the definitive publication of the list a “transitional regime will apply. Pending completion of the list of reference veterinary medicinal products and generic veterinary medicinal products authorized for marketing in Italy, the notification of substitution by the pharmacist has been maintained in the traceability information system. This notification will be eliminated following the preparation of the list of generic and equivalent medicines.
Validity of prescriptions: exemplary diagram and prescription forfeiture in triplicate, non-repeatable copies
Among the other aspects taken into consideration by the Ministry in the operational note there are some indications on the requirements. In detail, «Article 28 sets the validity of the non-repeatable veterinary prescription at 30 days from the date of issue and the validity of the repeatable veterinary prescription at 6 months, with the possibility of use a maximum of ten times. With the entry into force of the decree, the non-repeatable triplicate recipe expires; it follows that all medicines authorized with the non-repeatable triplicate prescription are considered authorized with the non-repeatable prescription. The traceability information system will implement the new changes from 18 January 2024, while the printouts of these veterinary medicinal products, including those authorized with a centralized procedure, will be updated with the first change in the MA that impacts them, without the need to submit a change ad hoc”.
There are also clarifications on the introduction of medicines from other member states and imports from third countries, the procedures for which are defined by article 30. What is reported is «an exemplary diagram which describes the cases in which an authorization or a simple notification and the cases in which the veterinary doctor can act directly under his own responsibility without further obligations with respect to the veterinary prescription.
With regards to the notification of introduction, at the moment the presence of a Rev for a foreign drug in the system is considered sufficient. In this regard, it is communicated that a new section relating to the electronic veterinary prescription for foreign medicine will be implemented. An update of the online forms and services is also planned for cases where ministerial authorization is required.
Compatibility of the role of warehouse manager with parapharmacy pharmacist
With regard to the issue of traceability, «Article 2, paragraph 2, of the decree introduces the definition of traceability information system, which means the system of the central database of drug traceability (Bdc), and the information system national for pharmacosurveillance. Article 16 then introduces the obligation for all subjects involved in the distribution, prescription, dispensing and use of medicines to register their personal information before starting the activity and, subsequently, any change in the traceability information system. The same article also establishes that all mandatory registrations defined by the regulation and the decree are included in this system”.
Finally, a reflection also concerns the compatibility of the role of manager of a wholesale distribution warehouse with a pharmacist in a parapharmacy. With regards to the wholesale distribution activity, article 17 of the decree provides that the person designated as warehouse manager has a degree in Pharmacy or in Pharmaceutical Chemistry and Technology or in Industrial Chemistry and carries out his/her continuous activity in the location indicated in the authorization, with a timetable compatible with the needs deriving from the size of the distribution activity carried out. The current decree of the Minister of Health of 19 October 2012 provides, among the “organizational requirements” listed in Annex 1, that for the retail sale of veterinary medicines in parapharmacies, the presence of one or more pharmacists, authorized to practice, is guaranteed. of the profession and registered with the relevant professional association for the entire opening hours of the business. Therefore the two roles are compatible if the aforementioned activities are carried out at non-overlapping times and are carried out by a pharmacist. The organization of these activities must be indicated in the quality document referred to in Implementing Regulation (EU) 2021/1248, kept available to the territorially competent authorities. The existence or otherwise of compatibility, therefore, is assessed as part of the checks by the territorially competent authorities.
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