Parabens, use and effects

In the latest decades, people has been devoting more attention to taking care of their body and appearance, and this has involved an increased use of cosmetic products for daily application. At the same time, the search for natural product has also increased, i.e. with no ingredients that might be potentially hazardous for our health. Today consumers are, in fact, more careful about the quality of the products they use and pay more attention to the indications reported in the labels. As far as cosmetic products are concerned, a European regulation regulates this matter and provides for specific indications regarding the composition. There is a list of banned ingredients that is continually updated, while concentration restrictions are provided for other...

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The import of medical devices in Italy

Importazione di dispositivi medici

The concept of “import” is not precisely straightforward, even if it is considered trivial. Initially “import” meant the transit of products through a country border. However, the concept of “import” considerably narrowed after the deals signed between the Member States inside the European Union. An importer is “any natural or legal person established within the Union that places a device from a third country on the Union market” in the medical devices field. Therefore the medical devices are imported in Italy only when they come from countries located outside the European Union. The medical devices undergo vigilance activities, performed by the “Uffici di Sanità Marittima, Aerea e di Frontiera” (USMAF-SASN and relevant territorial units) of the Italian Ministry of Health...

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Clinical trials information system (ctis)

Sistema informativo sulle sperimentazioni cliniche

The single European Clinical Trials Information System (CTIS) will come into force along with EU Regulation 2014/536 on clinical trials of medicinal products for human use on January 31st, 2022, as stated by publication in the European Official Journal. To report it is a note of the European Medicines Agency (EMA) that will also be responsible of the management for the system, while the authorization and supervision of clinical trials will remain responsibility of the Member States. EU Regulation 2014/536 aims at harmonizing the submission, evaluation and supervision processes of clinical trials across the EU. CTIS will serve as the single access point for submission of data and information concerning clinical trials. It will also facilitate communication between Sponsors and...

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Traceability of cosmetics for the safety of companies and consumers

Rintracciabilità cosmetici

Cosmetic products include a wide range of items (creams, shampoos, body care and hygiene products, but also make-up and sun care products), therefore, their use is extremely widespread and involves different types of consumers. However, not all stakeholders are aware of the legal obligations and rules that have to be respected in order to market a cosmetic in a manner that complies with industry regulations. The current reference text is Regulation (EC) No 1223/2009 of November 30th 2009, which is applicable from July 11th 2013; in addition, there are also other official documents and guidelines that help the different actors (manufacturers, cosmetic companies, distributors, etc.) in the sector to follow the legislation properly. For each cosmetic product, a responsible person...

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Marketing narcotics: regulations and criticalities

Commercializzare stupefacenti

Obtaining the marketing authorisation for narcotics is a delicate procedure, regulated by specific norms whose compliance is carefully monitored by the Italian Ministry of Health. The authorisation to the wholesale of narcotics and psychotropic substances and all their preparations is issued by the central narcotics office of the Ministry of Health. It authorises those who obtain it to carry out business operations in Italy, in the European Union and in the rest of the world. Not every stakeholder of the pharmaceutical chain can, however, apply for this authorisation. For narcotics, the regulations in force provide for a very limited list of subjects that can apply for it and get it: warehouses and wholesalers of human and veterinary medicinal products having...

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Hotel and cosmetics: regulatory aspects

Cosmetici per hotelleria

In the summer, everyone needs to recharge their energy with a nice holiday, especially in this period, when the pandemic situation is taking its toll. Tourism can start again and so can the hotel industry. Many hotels, along with accommodation, also offer the possibility to access dedicated wellness centres. Offers combining business and pleasure includes proposals for the care and well-being of people. Big hotel facilities, including luxury hotels, can provide their clients with welcome courtesy lines and/or kits for beauty and hygiene. There are many examples of hotel cosmetics, that can also be customised on request. These are mainly bath products (soaps, shampoos…), that can be combined – especially in luxury hotels – with perfumes, beauty masks and/or body...

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European Authorized Representative for Medical Devices: from old Directive 93/42/EEC to new Regulation 2017/745

What kind of responsibility has a European authorised representative of medical devices? The response is in the text of Regulation 2017/745 EU, applied as of 26 May 2021. Differently from what has happened for distributors and importers, the role of the authorised representative was already defined in Directive 93/42/EEC and in its national implementing text, Leg. Dec. 24 February 1997, no. 46. The level of responsibility of the authorised representative on legal issues caused or related to medical devices of extra-EU manufacturers according to the Directive was not particularly detailed. Actually, the only responsibility of the authorised representative was expressed in art. 18(a). At national level, on the other hand, Leg. Dec. 24 February 1997 – the Italian implementation of...

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N-nitrosamine contamination in drugs: European Pharmacopoieia review and practical applications

N-nitrosamines are organic compounds that are possibly carcinogenic to humans. They are contained in some foods, in drink water supplies, and some classes of drugs. As of 2019, several EMA and AIFA guidelines have stressed that prolonged exposure above specific levels of N-nitrosamines increases the risk of cancer in humans, urgently requiring an accurate review of medicinal products to all MA holders of drugs containing chemical or biological active pharmaceutical ingredients (APIs), in order to prevent and contain N-nitrosamines content. The determination of the potential risk of N-nitrosamine formation/contamination is possible thanks to the support of the European Pharmacopoeia, that is continuously updated by EMA guidelines. The impurity control can be carried out consulting the monographs of the individual substances,...

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Switzerland – EU: MRA and Swiss authorised representative

The agreement 0.946.526.81 on the mutual recognition of conformity assessment (MRA) has made easier, in the last 22 years, the free exchange of goods between the Swiss Confederation and the European Community. Such agreement also covers medical devices. For this category of products, on 26 May 2021 Regulation 2017/745 EU repealed Directive 93/42/EEC. The European Union and Switzerland have never reached an agreement allowing the update of the mutual recognition agreement within the new legislative framework. Basically, the European Commission subordinates the MRA update to the progress in the institutional agreements, whose negotiation is still going on. The European Commission is only available to negotiate the transitory provisions for medical devices according to the old legislation. Such circumstance implies, thus...

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What is a novel food and how to market it

Vendere Novell Food

Consumers’ food choices tend to vary in time and, especially in recent years, new types of foods have arrived on our tables. Possible causes can be identified in the growing ethnic variety and in an increased globalisation. This trend imposes, at regulatory level, the presence of a clear-cut, well-defined regulation allowing the marketing of food products that are safe for consumers. The concept of “novel food” is not a novelty at all. During history, in fact, new types of foods, ingredients or food manufacturing processes have appeared all over Europe from various regions of the world. The first European norm on novel foods goes back to Regulation (EC) 258/97 of the European Parliament and of the Council; however, the European...

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