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.
martedì 30 ottobre 2012
giovedì 25 ottobre 2012
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.
mercoledì 24 ottobre 2012
Pharmacovigilance: formal EMA investigation against multinational
The European Medicine Agency launched an infringement action against a multinational company for serious violation of the pharmacovigilance obligations on twenty products authorized through CP.
The action follows an inspection carried out by the British regulatory authority (MHRA), which detected serious faults in the company pharmacovigilance procedures.
The infringement action was started based on art. 5 of Regulation EC no. 658/2007 concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004.
EMA will report on the investigation outcome to the European Commission which may impose fines or periodic penalty payments if the violation is confirmed. EMA will proceed with an assessment of the general impact of the violation on public health.
Pharmacovigilance is more and more preponderant among pharmaceutical companies’ activities and requires a remarkable organization and great responsibilities.
Born out of the increasing need to continuously control the efficacy of medicinal product in their post-marketing phase, its aim is to collect information on medicinal products, as well as on their efficacy and in particular on their adverse reactions.
Di Renzo Regulatory Affairs is able to offer a wide range of pharmacovigilance services in compliance with current European and National regulations and legislations:
- Control of National network of pharmacovigilance for possible adverse reactions related to the products
- Request of follow-up information to the local pharmacovigialnce responsible person
- Preparations of forms
- Transmission of ICRS and information on pharmaceuticals through the Eudravigilance network
- Search and evaluation of literary cases, and of safety and efficacy studies
- Preparation and submission of PSUR to the Competent Authorities
- Local contact and Qualified Person for the Pharmacovigilance
giovedì 18 ottobre 2012
CPhI Worldwide exhibition
For the first time Di Renzo Regulatory Affairs participated in the CPhI Worldwide exhibition, held from the 9th to the 11th of October, with its own stand.
The event took place in the wide space offered by the prestigious Madrid Fair. It hosted several companies coming from all over the world, dealing with different sectors of the pharmaceutical field: medicinal products or API producers, experts in packaging, labelling or transport, manufacturers of cosmetics, medical devices, different types of machinery or equipment and many others, among which regulatory consultancy companies as Di Renzo Regulatory Affairs.
Such events are well known by those companies intending to work at international level. These exhibitions have become an essential instrument for the acquisition of important business contacts, for the choice of appropriate partners or in order to allow companies to join an always wider and more international sector.
We would like to thank once more those companies which came to visit us.
The event took place in the wide space offered by the prestigious Madrid Fair. It hosted several companies coming from all over the world, dealing with different sectors of the pharmaceutical field: medicinal products or API producers, experts in packaging, labelling or transport, manufacturers of cosmetics, medical devices, different types of machinery or equipment and many others, among which regulatory consultancy companies as Di Renzo Regulatory Affairs.
Such events are well known by those companies intending to work at international level. These exhibitions have become an essential instrument for the acquisition of important business contacts, for the choice of appropriate partners or in order to allow companies to join an always wider and more international sector.
We would like to thank once more those companies which came to visit us.
martedì 16 ottobre 2012
Raw materials importation
AIFA informed Italian companies about the European Commission communication on the obligation of written confirmation by the competent authority of the country of origin for the importation of pharmacologically active raw materials manufactured in extra-EU countries, starting from July 2nd 2013.
The EC communication informed that MAHs using imported pharmacologically active raw materials or derived from other imported pharmacologically active raw materials are invited to check that the extra-EU manufacturer complies with the requirement of the written confirmation within July 2nd 2013 (by checking for instance that the manufacturer was inspected by the competent national Authority of the manufacturing country or by a regulatory authority which is part of the PIC/S).
Pharmacologically active raw materials can be imported from extra-EU countries without the written confirmation only if originated by countries considered as “equivalent” by the European Commission. At the moment these equivalent countries are only four: Israel, Switzerland, Australia and Singapore.
If the concerned manufacturer is not able to grant a written confirmation, the company should proceed to develop an emergency plan to select new sources of the pharmacologically active raw material and submit the relevant variation application to AIFA.
MAHs are reminded that it is their specific responsibility to grant appropriate and continuous supplies of the medicines in order to satisfy the patients needs, according to art. 81 of Directive 2001/83 as amended, implemented in art. 105, sections 2 and 4, of Legislative Decree 219/06. Therefore, MAHs are bound to avert any risk of shortage due to the lack of a written confirmation starting from July 2nd 2013.
The EC communication informed that MAHs using imported pharmacologically active raw materials or derived from other imported pharmacologically active raw materials are invited to check that the extra-EU manufacturer complies with the requirement of the written confirmation within July 2nd 2013 (by checking for instance that the manufacturer was inspected by the competent national Authority of the manufacturing country or by a regulatory authority which is part of the PIC/S).
Pharmacologically active raw materials can be imported from extra-EU countries without the written confirmation only if originated by countries considered as “equivalent” by the European Commission. At the moment these equivalent countries are only four: Israel, Switzerland, Australia and Singapore.
If the concerned manufacturer is not able to grant a written confirmation, the company should proceed to develop an emergency plan to select new sources of the pharmacologically active raw material and submit the relevant variation application to AIFA.
MAHs are reminded that it is their specific responsibility to grant appropriate and continuous supplies of the medicines in order to satisfy the patients needs, according to art. 81 of Directive 2001/83 as amended, implemented in art. 105, sections 2 and 4, of Legislative Decree 219/06. Therefore, MAHs are bound to avert any risk of shortage due to the lack of a written confirmation starting from July 2nd 2013.
lunedì 15 ottobre 2012
Nano substances: cosmetics guideline
The European association “Cosmetics Europe” published a guideline on the correct implementation of Regulation 1223/2009/EC. The “Nano Guidance Package” is made of 5 documents, edited by special working groups formed by industry experts, in order to support cosmetic companies with the issues of nano materials when present in cosmetics. The association considered a Guidance was necessary due to the lack of more specific information by the Authorities. The guideline is currently available only in English.
venerdì 5 ottobre 2012
Regulatory Affairs Consultancy
Di Renzo Regulatory Affairs, whose headquarters are in Rome (Via Manzoni 59, tel. 06 77209020 FREE 06 77209020), has also set up a branch in Milan (Via Gustavo Fara 13, tel. 02 67380552 FREE 02 67380552).
Initially, the Milan office was only used for meetings with companies who required our consultancy.
As of November 2012 our Milan office will be operational in all respects, with the constant presence of our staff.
We will be happy to be contacted by and meet with companies who need our services.
The areas of our interest are medicinal products, medical devices, cosmetics, food supplements, biocides and disinfectants.
The flagship of our business is the pharmacovigilance unit, made up of a large and highly specialised staff.
In order to obtain more specific information regarding the nature of our services, please visit www.direnzo.biz
For more information: Sante Di Renzo, direnzo@direnzo.it
Initially, the Milan office was only used for meetings with companies who required our consultancy.
As of November 2012 our Milan office will be operational in all respects, with the constant presence of our staff.
We will be happy to be contacted by and meet with companies who need our services.
The areas of our interest are medicinal products, medical devices, cosmetics, food supplements, biocides and disinfectants.
The flagship of our business is the pharmacovigilance unit, made up of a large and highly specialised staff.
In order to obtain more specific information regarding the nature of our services, please visit www.direnzo.biz
For more information: Sante Di Renzo, direnzo@direnzo.it
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