CPhl worldwide – Frankfurt – 22-24 Octubre 2013

Di Renzo Regulatory Affairs participará en la feria CPhl worldwide, que tendrá lugar del 22 al 24 de Octubre 2013 en Frankfurt, stand n. 42J50.

Di Renzo ofrece servicios de consultoría en el ámbito de los dispositivos médicos para asesorar a los fabricantes de dispositivos médicos sobre la exportación de dispositivos con la marca CE fuera de la Unión Europea. Para la comercialización de dispositivos médicos en algunos países extracomunitarios es suficiente presentar un certificado de venta libre expedido por la autoridad competente del país en el que se encuentra la sede del fabricante. Para otros países, como por ejemplo los Estados Unidos, es necesario responder a los requisitos de la FDA. Di Renzo ofrece sus servicios a las empresas interesadas tanto en el mercado europeo como el mundial.

CPhl worldwide 2013

La Di Renzo Regulatory Affairs parteciperà alla fiera CPhl worldwide, che si terrà dal 22 al 24 Ottobre 2013 a Francoforte, stand n. 42J50.

La Di Renzo offre servizi di consulenza nell’ambito dei dispositivi medici per supportare i fabbricanti di dispositivi medici nell’esportazione di dispositivi marcati CE fuori dai paesi appartenenti l’ Unione Europea. Per commercializzare i dispositivi medici in alcuni Paesi extra EU è sufficiente fornire un certificato di libera vendita rilasciato dall’autorità competente del paese in cui ha sede il fabbricante. Per altri paesi, come per esempio gli Stati Uniti, è necessario rispondere ai requisiti dell’ FDA. La Di Renzo offre supporto alle aziende interessate sia al mercato europeo sia mondiale.

CPhl worldwide event in Frankfurt – October 22-24th, 2013

 

Di Renzo Regulatory Affairs will take part to the CPhl worldwide event in Frankfurt this year as well.

This is a very interesting occasion for international companies attending the event and visiting the booths to learn about the potentials of the organization set up by his owner, Sante Di Renzo, in thirty years of activity.

The group currently comprises of almost 60 people, most of whom are graduated in scientific subjects, and deals with regulatory affairs for human and veterinary medicines, medical devices, cosmetics, food supplements, biocides.

It also have an efficient pharmacovigilance unit (made of almost 20 people, including two QPs and two physicians), a devicevigilance unit and a cosmetovigilance unit.

The company’s main office is in Rome, with a branch in Milan and one in London. The opening of other branches in other parts of the world is scheduled, stressing the international vocation of the organization.

All companies interested in meeting us are invited to visit our booth no. 45J50 or to send us an e-mail to make an appointment.

Latex-containing packagings

The Pharmacovigilance Office of the Italian Medicine Agency (AIFA) required all pharmaceutical companies to check that a warning regarding the presence of latex rubber in the primary packaging material or in medical devices supplied with some medicines is duly reported in the PIL of medicinal products.

The warning, provided for by the guideline Excipients in the label and package leaflet of medicinal products for human use, is the only way to protect patients suffering from allergies to latex. Italian hospitals have recently reported cases of latex-related anaphylactic shock and the AIFA pointed out that, although latex is not considered as an excipient, it is often contained in vials’ stoppers or in plungers of pre-filled syringes.

The warning states the following: “The container of this medicinal product contains latex rubber. May cause severe allergic reactions”.

In case such warning is not reported, the Company will have to submit a variation application to the Competent Authority as soon as possible, in any case no more than 30 days from the receipt of this communication, according to Regulation EC no. 1234/2008, in order to include this warning in the PIL.

Red yeast rice: alert from France

The French Agency has launched an alert on food supplements containing red yeast rice, often labelled with claims on control of blood cholesterol. 

The Agency underlined that although containing monacolin K (also known as lovastatin) showing the same chemical characteristics of statins, products containing red yeast rice should not replace the therapies prescribed by the physician against cholesterol. Besides, after some reports of adverse events related to the use of such supplements, they should not be recommended to patients already under pharmaceutical treatment. 

These reports led to a review by ANSES (the French food safety agency) which assessed all the risks due to the consumption of these supplements. For the moment only few cases were reported, but the undesirable effects detected were similar to those listed for statins used in pharmaceutical products, such as increased frequency of muscular pain and increased hepatic enzymes with signs of jaundice. 

Therefore, the Agency has warned patients against the replacement of anti-cholesterol therapies with food supplements containing red yeast rice, especially in case of statin intolerance, since the undesirable effects are the same. Patients already treated with an anti-cholesterol therapy or receiving medicinal products interacting with statins should not take these supplements. Also grapefruit and grapefruit juice consumption should be avoided since this can increase the exposure to lovastatin with consequential overdose risk. 

Finally, patients were reminded that the therapy for hypercholesterolemia should always be accompanied by an appropriate low-fat regime and physical exercise.

Safety of cosmetics phthalates confirmed

Scientists and researchers of the Scientific Committee on Consumers Safety confirmed the safety of the only phthalate used in cosmetics sold in Europe. This is diethyl phthalate (DEP), added in small amounts to bitter the taste of ethylic alcohol when contained in the formulation.

The Committee reacted to the warning launched by the Washington University of St. Louis, according to which phthalates exposure results in premature menopause.

Considering that this is a wide class of chemicals with different characteristics and properties, the Committee confirmed that phthalates with negative characteristics are forbidden in cosmetics and therefore no cosmetic product containing such phthalates is available in the Italian and European market.

Besides, cosmetic products are regulated by strict European and Italian regulations, which guarantee consumers’ safety.

Teeth whiteners

From next October 31st teeth whiteners containing up to 6% of hydrogen peroxide cannot be marketed as medical devices. These products will be in fact considered as cosmetics.

Teeth whiteners containing less than 6% of hydrogen peroxide are still under discussion at European level and for the moment can be kept on the market as medical devices.