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Regulation on food for special medical purposes

Delegated Regulation (EU) 2016/128 of 15 September 2015 applies as of 22 February, except for the provisions for food for special medical purposes developed to meet nutritional needs of infants (for which the Regulation will apply as of 22 February 2020). Regulation 2016/128 integrates Regulation (EU) no. 609/2013 regarding specific prescription on composition and information for  food for special medical purposes. Regulation 609/2013 is a novelty in the norms of this sector and has gradually abrogated all previous national regulations for the different classes of products (infant formula, follow-on formula, processed cereal-based foods and baby foods, food for special medical purposes and total diet replacement products for weight control). A regulation was required to ensure the correct functioning of the...

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

Is an Authorised Representative (AR) jointly liable for the medical devices of the manufacturer? There is no easy answer because it depends on the Member State implementation of the European Directive 93/42/EEC (MDD). On the matter of AR liability for legal issues caused or related to medical devices of extra-EU manufacturers the old MDD is quite superficial, as the only direct responsibility addressed to the AR is given in Art.18(a). We are excluding all AR responsibilities related to documentation and information duties, which can be assumed to be relatively easy to manage. Furthermore, MDD does not state any position on further liabilities for ARs. So the question moved on to the national level, within the limits posed by the MDD...

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Antifraud stickers and traceability of medicines: in Italy still until 2025

Drug serialisation is a tool to improve product safety, ensure patients’ health and prevent frauds. As of February 2019 all Countries shall comply with the new European serialisation system, with the sole exception of Italy, Belgium, and Greece that – already having a drug traceability system in place to monitor drug supply and distribution – were granted a time extension until 2025. More specifically, in Italy article 40 of Law 1st March 2002 no. 39, provides for the set-up of a central Database at the Ministry of Heath, collecting all manufacturing and supply data of numbered stickers for medicinal product and recording any transaction of the single packs. Article 40 establishes that all actors of the pharmaceutical chain – from...

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Pharmaceutical Conferences and congresses

In order to organise conferences, congresses, or meetings opened to health professionals, in Italy or abroad – on topics related to the use of their own manufactured or marketed products - pharmaceutical companies need to apply for an authorisation to the competent AIFA unit, ate least sixty days before the date of beginning of the event, in compliance with the provisions of article 124 of Legislative Decree 219/06. Based on the sum paid for the organisation of the event – either direct or indirect funding – the sponsor shall pay a fee to the AIFA and the Ministry of Health and associate a POL (payment on line) to each application of authorisation. In case of training conferences and congresses only,...

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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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