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Workshop on narcotic and psychotropic substances

The first workshop on narcotic and psychotropic substances (Update on the management of import and export licenses, quarterly and annual reports, necessity forecasts) was held on 21 may 2019 at the Italian Ministry of Health. The event was organised by the trade and logistic operators association (ASSORAM) in cooperation with the Narcotics Central Unit of the Italian Ministry of Health. The event has allowed concerned operators to address and discuss in practice the main deadlines to comply with and the methods to fill in import and export license requests appropriately. Companies entering into contact with narcotic and psychotropic substances are in fact subject to more regulatory requirements. This subject is particularly delicate and it is regulated by several international conventions....

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Wearables and domotics for custom-made therapies

The results of a new sensor device to detect the movements of patients with Parkinson disease revived the interest in custom-made devices and for domotics applied to health. The concerned device can be worn on the wrist or ankle and is connected to an algorithm: the collected data on daily activities (walking, dressing, moving) are analysed in the light of drug administration to assess the actual patient’s response to therapies. This new approach to therapy customization is the last frontier in the field of devices for the creation of tools monitoring patients without excessive interference in their lives, able to collect information to be transmitted to health professionals. Wearable medical devices, for instance, the so called ‘wearables’, are more and...

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The reasons behind our choice

What we built in these 30 years of regulatory activity has now reached maturity. The Art Nouveau building that hosted the headquarters of Di Renzo Regulatory Affairs, from its first 5 employees to the nearly 100 of today, has become – day after day, year after year – more and more squeezing. Habits and affections for this well-known location have been a special glue, but three years ago I started to look for a new place, because I believe that people have the right to work in a wide, dynamic, bright, comfortable space, with maximum availability of means and expression. In this adventure I brought with me anyone wishing to follow, to grow together professionally and I hope – also...

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Cosmetic importation from extra-EU countries: economic benefit in compliance with the European regulations

It often happens that extra-EU companies, and sometimes even people coming back from China, Philippines, Iran and other, think that they can easily import cosmetic products into the European Union, believing that the process is very simple. On the contrary, it is very important to stress that the cosmetic products marketed in the EU must comply with the safety requirements provided for by the European regulations. In particular, the person importing cosmetic products into the EU is directly responsible of the products marketed in the European territory and must therefore ensure that raw materials and manufacturing are in compliance with the standards of the cosmetic good manufacturing practice (NBF) (UNI EN ISO 22716). This document establishes the guidelines for the...

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New headquarters for Di Renzo Regulatory Affairs

Two thousand square meters on four floors, and almost 100 employees. This is the new face of Di Renzo Regulatory Affairs. After more than 30 years spent in our historical headquarters of Viale Manzoni, as of May 2019 the Company will move to the headquarters in Via dell’Arco di Travertino 11, in Rome, to gain more space for our increasing international and dynamic vocation. The new headquarters are free-standing, modern, sunny and surrounded by greenery, and perfectly embody the values of quality, organisation, dynamism and internationalisation that Di Renzo Regulatory Affairs has been carrying forward as its own project since its foundation. The new headquarters bind the architectonic and functional aspect - taking care of the staff well-being - with...

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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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