Medicinal products
What is a medicinal product?
As reported on the website of the European Medicines Agency, a medicinal product is a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action.
What is a medicine made of?
Each medicine contains one or more active pharmaceutical ingredients (APIs) and various excipients.
The active ingredient is the component on which the pharmacological action depends.
Excipients, instead, are inactive components whose presence is necessary for reasons related to the manufacturing process.
In other words, they do not have any curative property, but are added to the drug for several reasons:
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to improve the stability and preservation of the product
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to give volume, shape and texture to the product (if the drug contained only the active ingredient, it would often be so small in size that it could not even be handled)
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to allow the active ingredient to reach the site of action
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to prevent the product components from separating or forming lumps
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to make the product more palatable
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to increase the effectiveness and productivity of manufacturing machines.
Veterinary medicines classification
In general, veterinary medicines in Italy can fall under two groups:
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non-prescription drugs, which can be purchased by the customer at the pharmacy without any obligation or need for a Veterinary Electronic Prescription
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prescription drugs, which can be purchased by pet owners from pharmacies only if they have a Veterinary Electronic Prescription written by their veterinary doctor.
There is also a group of non-prescription drugs, including antiparasitics for external use (sprays, spot-on treatments , collars, etc.), whose sale is not reserved exclusively to pharmacies, i.e. they can be purchased in pharmacies as well as drugstores and specialized pet stores, without a Veterinary Electronic Prescription.
Veterinary Electronic Prescription
The Minister of Health’s decree “Modalità applicative delle disposizioni in materia di tracciabilità dei medicinali veterinari e dei mangimi medicati” (“Implementing Provisions on the Traceability of Veterinary Medicines and Medicated Feeds”) published in the Official Gazette introduced the Electronic Veterinary Prescription in Italy.
As of April 2019, digital prescriptions have completely replaced paper prescription in Italy. Each Electronic Veterinary Prescription has a Prescription Number and a 4-digit PIN generated by the system when the prescription is issued by the veterinary doctor.
Any pet owner can go to a pharmacist with the prescription number and PIN, or with their social security number and PIN. In this way, the pharmacist can acquire the digital prescription and deliver the medicine to the customer.
You can watch an information video on the YouTube channel of the Ministry of Health.
What are generic medicines?
A generic drug is an industrially produced medicine that is bioequivalent to an authorized reference or brand medicine with the same qualitative and quantitative composition in terms of active ingredients, the same pharmaceutical form, the same route of administration, and the same therapeutic indications.
The bioequivalence between two medicines is the demonstration of the therapeutic equivalence between two similar formulations containing the same active ingredient. Two products are bioequivalent when taking the same amount of medicine does not result in significant differences in safety and clinical efficacy.
For more information:
- Questions and answers on generic medicines (EMA/393905/2006 Rev. 2)
- Generic Veterinary Medicines (Communication from the Ministry of Health No. 0019135-01/08/2018-DGSAF-MDS-P).
Veterinary medicines and human medicines: are they the same?
Veterinary medicines are drugs intended for use on one or more animal species for curative or prophylactic purposes, or to make a medical diagnosis.
The authorization process for veterinary medicines is similar to the process required for drugs for human use.
For both types of medicines, the competent authority at the European level is the European Medicines Agency (EMA).
At the Italian level, the competent authorities for managing drugs for veterinary and human use are the Ministry of Health and the Italian Drug Agency (AIFA), respectively.
The development and production of veterinary and human drugs are also similar. However, medicines for human use are designed for just one species – humans – while veterinary medicines target multiple animal species.
In the veterinary field, it is necessary to develop specific medicines that can be used in different target species and on animals of different sizes, with ad hoc formulations and special routes of administration.
In addition, veterinary medicines for livestock, i.e. animals raised for human food production, require extra investments in Research and Development activities to check both their consumer safety (studying, for instance, the presence of residues in meat, milk, eggs) and environmental health.
As they are formulated especially for animals, veterinary drugs usually differ from human drugs in at least the following respects, despite sharing the same active ingredient:
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palatability, as in most cases the medicine contains veterinary-specific flavorings that make the product palatable for animals
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ease of administration of the correct dosage for each animal species; therapeutic doses that are suitable for humans are almost always not suitable for animals
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different excipients, depending on the target animal species; some excipients used for human medicines may be contraindicated, or even harmful, for animals.
