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Brexit’s MHRA guideline for medical devices

The British competent Authority MHRA has published a guideline on their website on the Brexit, that is constantly updated: “Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal”. In particular, a section was published during the latest update on 4th January 2019 regarding the registration of medical devices marketed in the United Kingdom. As of 29th March 2019, ale medical devices, active implantable medical devices, IVDs and custom-made medical devices needs to be registered at the MHRA before being marketed in the United Kingdom. As this is an extension of the registration requirement in force, there will be a grace period to comply with the new registration process, in particular: 4...

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Herbal substances and preparations in food supplements

The provisions of Decree 10 August 2018 of the Ministry of Health, as updated by Decree 9 January 2019 regarding Annex I regulating the use of herbal substances and preparations in food supplement is in force as of 9th January 2019. The Decree includes a detailed list of admitted ingredients specifying the botanical name and the family of the herbal substance and any synonyms, where present. The parts of the plant that are admitted are also specified as well as any additional warning to be reported in the label and, for some ingredients, the indications to be complied with to ensure a high level of safety for the consumers. The physiological effects already reported in the Ministry reference guidelines have...

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Food subject to notification – state of the art of the online procedure

Five months after the entering into force of the new electronic notification procedure instituted by the Italian Ministry of Health for food subject to notification, companies need to carry out a careful control of the status of the notifications performed so far for their products to maintain them on the market. The Ministry of health has in fact also updated the registries reporting the list of notified products. Currently tow registries are temporarily available for each of the following categories: food supplements formulas for infants food for special medical purposes gluten-free food specifically formulated for people suffering from celiac disease. However, as of 1st July 2019 one single register will be published and only the products included in it can...

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12° Info Day – Veterinary medicines

As every year, the Ministry of Health has met the actors involved in the manufacturing of veterinary medicinal products, dedicating 2 days to the information on veterinary products. This is the 12th edition of this event: there were interventions by ministry officers as well as representatives of MA holders and manufacturing sites of veterinary medicinal products. Such participation has allowed the sharing of issues and needs by all concerned parties. There has been much work done as well as many goals achieved. A further workload originated from the Brexit. Within 30th March 2019 all procedures shall be transferred to the Competent Authorities of the EU Member States. A RMS switch is therefore ongoing, currently completed for 63% of the veterinary...

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Ministry updated the list of ingredients admitted in food supplements

The Italian Ministry of Health has published a new update of the list of other nutrients and substances with nutritional or physiological effects (the latest version of the document was the revision of March 2018) and has circulated a brief note clarifying the changes introduced. In particular, the warning regarding the presence of lipoic acid was changed: the reference to the intake of lipid-reducing drugs was deleted and a warning was included on the need to ask for the doctor’s advice before using the product as lipoic acid can rarely cause hypoglycaemia. The occurrence of hypoglycaemia can in fact be related to the intake of the substances containing sulfhydryl groups (as lipoic acid), but there is no specific relation with...

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Project management and the role of the Clinical Project Manager

The type of company or project management strongly influences the objectives to be achieved while remaining within the cost and time constraints For example, the management of a company or of a "silos" project appears in a traditional view of the coordination models, which highlights both the hierarchy and the vertical organization among the various departments (or parts of a project) , both the clear separation and the preservation of a single link in the chain, preventing an opening both in and out of the other sectors. This kind of organisation has negative consequences on the achievements of the scopes, as the lack of communication and inter-exchange leads to a shift in priorities, from a wider interest in success to...

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The role of statistics in clinical trials

Statisticians and biostatisticians are more and more present in clinical trials, since the early stages, like for instance the design itself. On the contrary, until recent years statistics was referred to only after the conclusion of the trial, often with negative effects. Today it is neither ethical not scientifically acceptable that patients undergo therapies, tests and treatments that are not necessary and whose use is not rational. In the light of these reflections, the role of the biostatistician becomes essential to manage and interpret any data from clinical research. It is a very important figure in any clinical trial, from its design to its carrying out, from analysis to documentation, for the control and containment of distortions and misleading factors...

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Online procedure updated for food subject to notification

The Ministry of Health has published a note to clarify the actions to be taken for the products notified up to 2014. The products involved are those classified as food supplements, formulas for infants, food for special medical purposes, gluten-free food specifically formulated for people suffering from celiac disease and food added with vitamins and minerals. In particular, the notifications dating before 2008 and not updated afterwards, are considered automatically expired; whereas notifications or movements occurred between 2008 and 2014, if concerning products that are still on the market, should be updated by notifying the latest version of the label with the new online system no later than 30 June 2019. The requests were triggered by the constant update of...

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Food Supplements sale in Italy

The sale of food supplements in Italy, through either traditional channels or online, is steadily growing and many companies are widening their activities in this sectors by developing international relations and changing their websites in consequence. These are supporting products that can be used by consumers to integrate the intake of specific substances in case of deficiencies or increased needs. As for Italy, the number of foreign companies actively engaged in a constant penetration of the national market (and therefore bound to comply with the strict requirements of the national legislation and Italian notification system) has increased. We know that in the latest years the increased sales of food supplement has much grown at international level and this has allowed...

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In vitro diagnostic medical devices (IVD): from the Directive to the Regulation 2017/746

The transition from the old Directive on in vitro diagnostic medical devices 98/79/EC (IVDD) to the new Regulation 2017/746 (IVDR), which will apply from May 26th 2022, will be more of a landmark than the transition from the Directive on medical devices 93/42/EEC (MDD) to its new Regulation 2017/745 (MDR). Whereas for medical devices, the new MDR represents a systematizing upgrade of many arrangements, positions, procedures and decisions already variously existent in the regulatory landscape (plus new prescriptions that conversely can be also considered as technical extensions rather than new orientations), if not predictable remedies to experiences gained through the years (from scandals to borderline practices), many changes introduced by IVDR with respect to the old IVDD are real novelties...

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