New Government Decree introduced by the MoH

The Italian Prime Minister and the Ministry of Health introduced in Rome a new Decree which has just been approved, including measures to assure health protection as well as expense reduction.

The decree provides for the reorganization of the NHS and the Ministry of Health, and includes urgent provisions on specific health issues. The most relevant measures include a rearrangement of territory health assistance, new rules for private practice by NHS doctors, an update of the essential care levels and the promotion of healthy lifestyles (smoking and gambling).

Moreover, the health professional responsibility is further regulated, especially regarding the so called “defensive medicine”, i.e. the prescription of inappropriate laboratories tests and diagnostic procedures with the aim of avoiding any malpractice liability.

The decree also provides for interventions and measures on food safety and animal health, hospital building and research, and aims at assuring more transparence in the appointment of NHS general managers and head physicians.

As for pharmaceutical management, the decree will assure prompt access to innovative reimbursed drugs by patients in all Italian regions. Out-of-date pharmaceuticals will be deleted from the National Reimbursement List (PFN) and pilot schemes for new tailored made pack-sizes will be implemented in order to reduce product waste and misprescription.

Documentation access: regional court upholds appeal against documentation access denial

The sentence of a regional court on July 24th 2012 upheld an appeal made by a pharmaceutical company against the refusal by the Italian Medicine Agency (AIFA) to grant access to the documentation reporting the holders of MA applications for generic drugs.

AIFA postponed the documentation access to the end of the preliminary phase, on the base of the provisions established by the same Agency in a communication dated September 16th 2010, i.e. the chance to access documentation only after the CTS (Scientific Committee) or CPR (Price and Reimbursement Committee) have expressed their opinion.

The regional court upheld the appeal declaring such postponement as arbitrary, since the AIFA communication only intends to avoid any delay in the issue of generic MAs due to any court appeal. The court also declared the postponement as unjustified in case the access requests do not hinder the continuation of administrative activities.

Moreover, the court established that the list of holders which submitted a MA application should be communicated to the company concerned and used to forward a communication on the expiry date of complementary protection certificates underlining that equivalent drugs cannot enter the market before the day after the expiry.

Manufacturing sites: electronic submission

The AIFA Manufacturing Sites Authorization Office published a communication for all pharmaceutical and active substance manufacturing sites regarding the submission of documents in electronic format.

From September 5th, the Manufacturing Sites Authorization Office will accept and request the submission of documents in electronic format, according to the provisions of article 42 of Legislative Decree March 7th 2005, no. 82, updated by Legislative Decree April 4th 2006 no. 159 and Legislative Decree December 30th 2010 no. 235, for the gradual elimination of paper records and their replacement with electronic documentation.

The documents affected by the new pilot electronic submission are the following: Site Master Files and their relevant attachments, excluding site planimetries (such as HVAC, PW, WFI); technical documentation enclosed in the application for the activation and extension of the authorization to pharmaceutical and active substance manufacturing for the market and for clinical trials, excluding site planimetries (such as HVAC, PW, WFI); technical documentation enclosed in the resolution to deviations detected during inspections , excluding a summary outline of the corrective measures adopted and any planimetry.

Any excluded document will have to be submitted in paper format.

Manufacturing sites will have to submit the electronic application also in paper format, according to the methods in force, which should include a list of the document contained in the electronic device. The electronic device will have to be identifiable both for the content and document version.

Holders of authorizations for the manufacturing of pharmacological active substances, medicinal products, medicinal gases, holders of GMP authorizations and/or certificates issued by AIFA, can send the a.m. documentation on electronic CD, in non modifiable format (.pdf; any picture or image will have to be in .jpeg, .jpg, .gif), replacing the documentation traditionally submitted in paper version.

Pay-back 2012

AIFA informed all pharmaceutical companies that the second and third instalments of the amount to be paid for the 5% Pay-back 2012 are to be paid within September 15th and October 6th 2012.

Payments receipts confirming the payment should be transmitted to AIFA within the following 10 days through the transparency system in the dedicated Pay-back area. Moreover, AIFA communicated that the 5% Pay-back payments were quantified on the basis of the well-established data of the previous year; therefore the total amount subscribed by the pharmaceutical company will not change.

The amounts of the second and third instalment correspond perfectly to the amount of the first instalment, with the exception of the pharmaceutical companies which paid outright. The terms cannot be postponed.

Di Renzo Regulatory Affairs participará en el CPhL 2012 de Madrid

Di Renzo Regulatory Affairs participará en la 23° edición del CPhL Worldwide que se celebrará en la Feria de Madrid del 9 al 11 de Octubre 2012.

El CPhL se celebró por la primera vez en el 1990 y la que se celebrará en Madrid del 9 al 11 de Octubre será la 23° edición de esta prestigiosa feria para el sector farmacéutico.

El numero de visitantes ha crecido de año en año hasta llegar a los 29.000 visitantes procedentes de mas de 140 países en la última edición.

El CPhl es un evento sin iguales para la comunidad global del sector farmacéutico. Desde años reúne las empresas farmacéuticas y permite la comunicación con potenciales colaboradores. Con las diferentes actividades que se tendrán en estos 3 días, informará las empresas sobre las ultimas novedades en el sector ayudándolas a mantenerse al día con en el mercado en continua evolución.

Los visitantes del CPhl son empresas que trabajan en todos los sector de la industria farmacéutica, que necesitan de innovación y desean encontrar nuevos productores de materias primas, nuevas tecnologías y servicios de consultoría para mejorar la propria situación.

Entre las diferentes empresas de consultoría, participará Di Renzo Regulatory Affairs, fundada en 1985 por Sante di Renzo, con oficinas en Roma y Milano.

Dispone de un personal altamente especializado de 45 personas, en su mayoría técnicos licenciados, y ofrece servicios de consultoría regulatoria para medicamentos de uso humano y veterinario, dispositivos médicos, material quirúrgico, biocidas, cosméticos, suplementos nutricionales, productos dietético, homeopáticos, gases medicinalaes, productos fitoterápicos.

Proporciona apoyo a las empresas en los procedimientos de reconocimiento mutuo, DCP y nacionales; prepara la documentación necesaria para las solicitudes de variación, trasferencia y renovación. Ofrece soporte en la contratación del precio del los medicamentos con AIFA, también en le sector de la farmacovigiláncia, trazabilidad de los medicamentos, información científica y preparación del expediente en CTD y eCTD.

Barry Italy obtains the CE certificate for its medical device

Barry Italy has just obtained the CE certification of a new disinfectant for surgical instruments. This is a medical device (MD) Class IIb, for high-level disinfection.

"We believe we have created a high performances product, clear and transparent in appearance, with a mild and pleasant aroma from the previously concentrated version, which is easy to use especially in the ready for use diluted packaging, which does not require any activation or pre -mixing. "

The medical device replaces the previous product and acts on fungi, bacteria, mycobacteria and viruses.

The product, available both in diluted and concentrated forms, meets the requirements of  UNI EN ISO harmonized standards relative to disinfectants used in health care.

Barry Italy Srl is a historic Italian company established in 1919 when Mr. G. Vittadini founded a factory to produce scientific glassware, and gave it his name.

Over time the company became Vittadini Instrumentation, with the express purpose of setting up a benchmark for the Italian market for the construction of chemical laboratories.

In 1981 the company expanded its product range and areas of product application and in 1996 a branch of the business was created, and Barry Italy Srl was established. Barry Italy has always been engaged in research, development and distribution of products related to water purification and largely in high-level disinfection.

The new EC medical device, adapted to the growing needs of the disinfection of the hospital sector, combines the experience and tradition of a consolidated product with a new formulation.

Even today Barry Italy continues ceaseless research and development of improved products and effective methods of addressing the problem of disinfection and sanitation both in hospital and at a personal level.

Barry Italia ottiene il certificato CE per il suo dispositivo medico

La Barry Italia ha appena ottenuto la certificazione CE del nuovo disinfettante per ferri chirurgici. Si tratta di un Dispositivo Medico (DM) di Classe IIb, destinato ad una disinfezione di Alto Livello.

“Riteniamo di aver realizzato un prodotto con elevate perfomances , con un aspetto limpido e trasparente, con un odore lieve e gradevole già nella versione concentrata, di semplice impiego specie nella confezione diluita pronto all'uso, che non richiede alcun tipo di attivazione o pre-miscelazione.”

Il dispositivo medico sostituisce il precedente prodotto e agisce su Funghi, Batteri, micobatteri e Virus.

Il prodotto, disponibile sia nella forma diluita sia in quella concentrata risponde ai requisiti delle Norme armonizzate UNI EN ISO relativi ai disinfettanti da utilizzare in ambito sanitario.

La Barry Italia S.r.l. è una storica azienda italiana che prende vita nel 1919, anno in cui l'Ing. G. Vittadini fondò una fabbrica di vetreria scientifica, chiamandola con il suo stesso nome.

Tale Società, nel tempo, si è trasformata in Vittadini Strumentazione, con lo scopo preciso di costituire per il mercato italiano un punto di riferimento per la realizzazione di laboratori chimici.

Nel 1981 l’azienda espanse la gamma di prodotti e i settori di applicazione dei prodotti, e nel 1996 venne creato un ramo d’azienda, e venne fondata la Barry Italia Srl.

La Barry Italia è stata sempre impegnata nella ricerca, nello sviluppo e distribuzione di prodotti inerenti anche alla depurazione delle acque e complessivamente alla disinfezione di alto livello.

Il nuovo dispositivo medico CE, adatto alle crescenti esigenze della disinfezione del settore ospedaliero, unisce l'esperienza e la tradizione di un prodotto consolidato ad una nuova formulazione.

Anche oggi Barry Italia prosegue nell’incessante ricerca e sviluppo di prodotti sempre migliori ed efficaci per affrontare il problema della disinfezione e igienizzazione sia a livello ospedaliero che a livello personale.