Category: Blog

The marketing of veterinary medicinal products is subject to the release of the relevant authorisation by the competent authority. In Italy the application should be submitted to the Ministry of Health that takes care of the release of authorisations of veterinary drugs to be used for the therapeutic treatment of animals, both for pets and for those intended for food production for human consumption. In the latter case, the assessment of the benefit/risk profile is particularly important. In fact, the essential goal is to ensure that the marketed medicines have quality, proven clinical efficacy and safety for both animals, operators and the environment. The marketing authorisation can be released via different procedures. This can be either a national procedures, if...

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The translation of specialised texts generally requires a deep linguistic competence (both in the source and target language), a good general culture and a detailed knowledge of the sector to which the text to be translated belongs. Linguistic competence is, of course, the base to become a high-level translator in any field of science, culture and knowledge in general. Preparing oneself in the linguistic area is a steady job, carried out in time, and including not only language courses and living abroad, but also a global interest in the culture of a country, in order to absorb the mind and thinking behind the development of the spoken language. Understanding the mind mechanisms leading linguistic thinking can in fact be as...

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We often talk about biocides and biocidal properties of a product, but the meaning of these terms is not always clear to everyone. Let's start with the definition. According to the regulation, a biocide is defined as any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. Thus, it is important to identify the ingredient or the ingredients with biocidal action, which are referred to as active ingredients. Obviously, not all the ingredients...

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The presence of products made in China and marketed in Europe and in Italy is often talked about. Several types of product reporting the wording “Made in China” can, in fact, be found in Italy and the debate about their safety is still open. The export of products from the European Union to China is, on the other hand, less known. Of course, it is required to comply with local regulations, i.e. Chinese law, before marketing consumption goods in the Asian country. When it comes to cosmetics, it is required to apply for a specific certificate to the Italian Ministry of Health. In general, a company intending to export cosmetic products outside the European Union can request to the Italian...

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As of 26 May 2021, Regulation (EU) 2017/745, replacing and repealing Directive 93/42/EEC will apply to medical devices. The requirements provided for by the Regulation also include indications regarding the registration of medical devices in a database for public consultation. Opposite to what happened with the Directive, where registration was regulated by the individual Member States, now a single European database has been instituted, i.e. Eudamed. However, so far, only one module of this database is accessible, regarding the registration of economic operators, while the module regarding the inclusion of medical devices will be published no earlier than next September. The individual national provisions regarding medical device registration are still in force. In Italy, Ministry Decree 21 December 2009, “Amendments...

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The possibility to sell medicinal products in stores other than pharmacies has been considered over the years, allowing the sale of non-prescription products also in parapharmacies and in the web. The availability of the Internet and a greater knowledge of milder diseases by a wider audience have helped opening regulated online sale channels: the current regulations only permit the marketing of non-prescription medicines and only by authorised online pharmacies. The authorisation to market medicines in digital channels is characterised by a specific logo that online pharmacies publish in their website. By clicking it, an automatic link refers the user to an official list of all authorised subjects operating legally (registered at the Ministry of Health). Users can verify whether the...

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Nine years have elapsed from the implementation of directive 2010/84, that deeply changed Pharmacovigilance management. In all these years, Regulatory agencies and pharmaceutical companies have made huge efforts, often in strict cooperation, to improve the processes regulating pharmacovigilance. On one hand, these improvements have simplified the management of some services compared to the past, on the other they have turned pharmacovigilance into a complex issue, full of activities and interactions, involving among the others: regulatory affairs, medical information as well as marketing. The goal is to ensure more health protection for patients, by monitoring drug safety and efficacy. All units, both at the competent authorities and at the pharmaceutical companies, had to invest capitals and human resources to be able...

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The manufacturing of all those product coming into contact, either directly or indirectly, with humans can affect their health, and for this world legislation has always taken care of ensuring the issue of laws, regulations and guidelines for all manufacturers, not only of medicinal products but also of medical devices, cosmetics, food supplements and PMCs (presidi medico chirurgici, medical surgical aids). In general, all manufacturing companies are bound to make excellent products, in order to ensure high quality and safety features of the finished product. In the pharmaceutical field, the Good Manufacturing Practice (GMP) is a tool created to induce and support companies to the accomplishment of this purpose. The GMP originates from regulating documents issued by the Code of...

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A little more than two years have elapsed since the new version of EudraVigilance has become effective, and any initial problems, mostly due to the difficulties met by the European authorities in the definition of a transition phase, appear to be solved. The purpose of the version, that became operational in November 2017, was to streamline and harmonize the reporting management, no more entrusted to national authorities, but rather managed centrally by the European Medicine Agency (EMA), the authority responsible for its development, maintenance and coordination. All this has allowed the improvement of suspected adverse reaction examination, reinforcing the monitoring of medicinal products and making data management more efficient. As known, EudraVigilance is a European platform for the management and...

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