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Regulatory privacy, data protection above all

Gestire la privacy dei pazienti

The entering into force of the Data Protection General Regulation, two years ago, has deeply changed the approach of companies to their clients and on the processing of data and information from relations and agreements with them. Such radical transformation also significantly affected the management of pharmaceutical regulatory affairs, in particular for consultants and contractors. The regulatory sectors concerned by the application of the new norms on privacy and personal data processing are in fact several, all linked to the presence of subjects outside the pharmaceutical company providing data for the performance of the required activities. The first compartment one thinks of is vigilance: safety monitoring of drugs, medical devices, food supplements, cosmetics, implies the collection of personal data of...

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Should veterinary medical devices be CE-marked?

Dispositivi medici veterinari

When a product falls into the field of application of a directive of the so called “new approach” providing for its application, a product must mandatorily present the CE marking. On the contrary, if the product does not fall into the scope of this kind of regulations, then it may not include it. In the case of medical devices, the current Directive 93/42/EEC regulating them refers only to products intended to be used in humans; consequently, everything used for medical activities on animals is excluded from the field of application. Although such criterion is quite clear, there are often products on the market classified as “veterinary medical devices”. This definition refers, for instance, to bands, patches, syringes for animals, but...

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Medical devices: the latest progresses in the post-Brexit scenario

Commercio dispositivi medici Brexit

The United Kingdom (UK) officially left the European Union on 1st February 2020. This decision resulted in the so called ‘transition period’, whose end has been fixed on 31 December 2020. The turmoil still existing at European and extra-European level on the topic of Brexit has brought significant developments. This article will examine some of them in depth. First of all, it should be specified that, even if some of the consequences on the medical device market depend on the outcome of the ongoing negotiations between EU and UK, the impact of other measures taken by the United Kingdom will be immediately effective and inevitable, also considering the less and less remote possibility of a “Hard Brexit”. The European Commission...

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The growing market of biosimilars

Farmaci biosimilari

According to the annual report published by the Italian trade association Assogenerici on teh sales of equivalent drugs, 2019 was a year of high growth for biosimilars. Not only there are more molecules available compared to the previous year – currently 14 – but their consumption increased of almost 80%. As known, biosimilar medicines are medicines highly similar to biological medicines (i.e. those derived from microorganisms, animal or human cells) already approved, but whose patent has expired. As it also happens for generics, biosimilars are similar to reference biological drugs in terms of quality, efficacy and safety but can differ due to a certain natural variability, based on their complex nature and on the different manufacturing techniques. Although they are...

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Food intended for sportspeople and weight reduction: the regulations

Alimenti per la perdita di peso

Summer is over, and everyone thinks about getting back in shape. People starts exercising again, also following an appropriate diet, and may be with the support of specific products. Foods intended for sportspeople and for weight reduction are a growing sector, that can count on a great variety of products for every kind of need. It is, however, a regulated sector, and the marketing of these products should meet some requirements regarding classification and labelling. Unfortunately, in contrast with other food categories (such as formulae for infants, or food for special medical purposes), sportspeople are not considered a class of persons with special nutrition needs. Therefore, when Regulation (EU) 609/2013 became effective, and Directive 2009/39/EC on foodstuffs intended for particular...

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What will happen when Brexit transition period is over

As known, the transition period established following the exit of United Kingdom from the European Union will end next 1st January, and the British Regulatory Agency MHRA is getting ready to take the handling of medicinal product procedures directly in their own hands. To this purpose, the Agency released a series of guidances in early September clarifying how medicines shall be registered when any bond with the EU is finally cut; a no-deal scenario with the European Union is at the base of the new provisions. The MHRA guidances address several issues certainly arising when the European authorities and directives are a reference no more. The focus is on preventing a shortage of medicines in the British market, a shortage...

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Medical Device Regulation – focusing on the unique device identifier

Regulation 2017/745 EU introduces measures supporting transparency and traceability in the field of medical devices. More specifically, a unique device identifier – UDI – was introduced. This is a code made of a sequence of alphanumeric characters where specific information regarding the device is coded. This system has already been adopted internationally, but never in Europe.  The European Commission has already designated the companies responsible for the release of the basic identification codes. For a full operability of the UDI the activation of the European database EUDAMED will be essential. This was also introduced by Reg. 2017/745 EU: through this, UDIs and information on economic operators and medical devices will be included and stored. In this way, the system will...

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CPPs, FSCs, GMPs: starting economic recovery from exportations

In this moment of uncertainty, linked to the unknown evolution of the COVID-19 pandemic, and to the stop to all activities that this caused in March and April, many Italian companies decided to bet everything on exportations to re-start the economic engine of our country. This also applies to health and hygiene products, from medicines to supplements, from medical devices to cosmetics. Even before the lock-down, the exportation of drugs and other products to European and extra-European countries represented an important profit for our economy, made easier by the use of the certifications acknowledged at international level, ensuring the quality and compliance of the exported products with the norms of the country where they are manufactured. Such certification is different...

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Safe drugs, the importance of pharmaceutical packaging

Pharmaceutical legislation ensures the quality and safety of medicines through the compliance with regulations and strict controls on all manufacturing steps as well as on all used materials. Such regulations and controls, however, do not concern only the active substances and the manufacturing processes turning them into the medicinal product to be marketed, but also the materials used for its packaging. The quality of the pharmaceutical packaging has in fact a primary importance, not only for the role it plays from the point of view of the product marketing: a packaging made with quality materials and according to the applicable norms ensures that the product remains intact and undamaged and that the information reported on it is clear. The pharmaceutical...

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Veterinary Regulations: animal feeds

Normative sui mangimi

In this particular period, with the pandemic changing our daily life and our habits, pets have become more important. Therefore, the attention and care we dedicate to them have also increased. Pets are, in fact, more and more considered as part of the family and their welfare should be ensured. From a regulatory point of view, however, products intended for animals are not all well regulated; quite often the reference is the corresponding legislation for the human sphere, as far as applicable. For medicinal products for veterinary use, and all related activities, including pharmacovigilance, the regulation is defined and processes are regulated. However, for cosmetics and medical devices for veterinary use, it is not possible to identify a reference regulation....

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