Project 231

The company business is carried out in a context which is full of laws, regulations and applicative policies which are continuously more complex, with updates almost daily. The legislation contained within the 231/2001 Legislative Decree, relating to the administrative responsibility of institutions, has for the companies an ever increasing role of importance. There are multiple rising benefits from the implementation of Model 231: from transparent and correct company management, to greater organisational transparency, to the balance between authorities and responsibility; from an improved risk culture and the monitoring of business operations, to the adoption of many good management rules and to the respect of related legislations, like those relating to health, safety in the workplace, the environment, finance, quality, privacy etc.
For these reasons Monetti Spa has decided to adopt an Organisational, Managerial and Monitoring Model in accordance with the 231/2001 Legislative Decree (Progetto 231) Currently the Model is under development and therefore the following operations are underway: evaluation of “The internal monitoring system” and company risks, identification of weak areas (gaps) and the preparation of improvement measures (remediation plan); The creation of a suitable Organisational Model; The definition of a code of ethics, protocols and policy; The identifying of members of the “Organismo di vigilanza ex D.Lgs. n. 231/2001” (surveillance organism) and the stipulation of rules of said organism. Programming of a suitable training plan.

Phytovigilance and Pharmacovigilance

PHYTOVIGILANCE

Food supplements are freely available products and should be used according to the instructions on the label. Improper use, which does not take into account age (such as infants and children), particular physiological conditions (such as pregnancy and breastfeeding), or ongoing pathological situations, could turn out to be counterproductive. It is therefore important to inform the doctor when using supplements, especially when prescribing drugs, also to avoid the risk of reactions from drug interactions. It is necessary to improve knowledge of the benefit/risk profile for the health use of a plant, considering in particular the nature of its specific derivative, the proposed intake amounts, the sensitivity and condition of possible users, and the concomitant consumption of other health products or drugs. For these reasons, it is necessary to carefully screen for adverse reactions to such products. Monitoring is aimed at increasing knowledge about the activity profile of the individual components and their possible interactions, which must necessarily go through ‘spontaneous reporting’ systems that are sufficiently sensitive to highlight any risk or warning signals at an early stage.
Since 12 December 2018, the VigiErbe website has been active
https://www.vigierbe.it/
where you can submit your report online.

 

PHARMACOVIGILANCE

Pharmacovigilance is the combination of the businesses that contribute to the safeguarding of public health. These are in fact designed for the identification, evaluation, comprehension and prevention of adverse effects or any other type of problem associated with the use of medicinal products, to ensure a benefit/risk ratio which is favourable for the population.
No medicine is actually risk free and therefore it is necessary to constantly monitor the security profile of products on the market.
The fundamental aims of pharmacovigilance are many and include:
Identifying as quickly as possible new adverse reactions caused by medicines and vaccines; Expanding the information available regarding suspected or already known adverse reactions;
Identifying risk factors predisposing the onset of suspected adverse reactions in relation to age, sex, dosage, underlying pathologies and pharmalogical interactions;
Confronting the safety profile of medicines belonging to the same medicinal group and assessing the advantages of a medicinal product compared with other available treatments for the same illness;
Communicating such information regarding safety with care to all health workers to improve clinical practice.

Relevant legislation
Regulation (EU) No 1235/2010 of 2nd July 2012, that amends Regulation CE No
726/2004
Guideline No 2010/84/UE of the 21 July 2021 that amends Guideline No 2001/83/CE
WHAT IS AN ADVERSE DRUG REACTION
Based on the legislation in the field of pharmacovigilance for adverse reactions (adverse drug reactions or ADR), means a “harmful and unwanted effect as a result of the use of a medicinal product”.
HOW TO REPORT AN ADVERSE REACTION
The European legislation regarding pharmacovigilance requires all health workers and citizens to report any suspected adverse reaction (severe and non severe, known and unknown).
The Health Ministers Decree of the 30th April 2015 reiterates the obligation to report immediately suspected adverse reactions to medicines and vaccines and has established time limits within which health workers are required to carry out a report to the National Pharmacovigilance Network (RNF), part of the AIFA.
Specifically:
Suspected adverse reactions by medicinal products are to be reported within 2 days from when the health worker comes to be aware of the reaction.
The obligation to report goes down to 36 hours in cases of ADR when the reaction comes from medicinal products of an organic origin (including vaccines).
It is possible to carry out a report of suspected adverse reaction according to one of the following procedures:
By filling out the suspected adverse reaction report form and sending it to the head of the Pharmacovigilance of the actual participating facility by email or fax Or online directly on the VigilFarmaco website following the guided procedure The report forms for health workers and citizens are available on the AIFA website in the forms section
(https://www.aifa.gov.it/moduli-segnalazione-reazioni-avverse).
Alternatively, the reporting of suspected adverse reactions can be communicated to the proprietor of the Community Register of Medicinal Products (AIC) of the medicinal product that is believed to have caused the adverse reaction.
The suspected adverse reaction can also be reported following the taking of
medicinal plant based products and nutritional supplements and of medical devices.
Below are the contact details for the relative competent institution websites and to the relevant forms:
Reporting of suspected adverse reactions to medicinal plant based products and nutritional supplements

To report online see the vigierbe website
To report suspected adverse reactions to medical devices

QPPV- Claudia Piccolo
Director of the Pharmacovigilance Service
Cell +39 3209655221
Tel +39 0818986293
Fax +39 08119713635
Mail claudiapiccolo@clinpharma.it
Cc: farmacovigilanza@clinpharma.it
qa@clinpharma.it

www.aifa.gov.it

Regulatory process

Regulatory affairs are important in many areas: medicinal products, supplements, food and cosmetics. Each of these sectors features its own regulatory framework.
The MONETTI Group employs professionals external to the company, that operate in the area of Regulatory Affairs and are predominantly responsible for overseeing the Molecule purchase procedures (AIC and Marchi) and of product sale licences.

Privacy

Monetti Spa candidates Policy

Monetti Spa customers and suppliers Policy

Monetti Spa employees Policy

Monetti Spa contact form Policy

Safety

Guaranteeing safety and health to our employees and collaborators, clients, suppliers and partners is our priority.
From the beginning of the emergency, in compliance with the governing decrees, we introduced special safety measures to give continuity to our business operations, minimising risk.
Management, the implementation of and the verification of these specialised safety regulations have been managed by the Vega Srl company, in partnership with the ad hoc nominated Covid Committee. Made up of the frontline business, it is a managing body that is responsible for evaluating and, if necessary, incorporating the established regulations.
The areas of intervention which have been defined as specific actions, established and continuously monitored by the Committee are the following 4: Organisation, Hygiene, Practice and Communication.

Quality

The Quality Accreditation is a strategic choice of a company which intends to achieve goals of improvement and continuous development of its processes and of continual client satisfaction.
With Kiwi Cermet Spa, one of the global leaders in the Testing, Inspection and Certification (TIC) sectors, VIM G Ottaviani Spa has obtained the new ISO 9001:2015 certification, which validates its effort in maintaining an efficient Quality Management System which conforms to standard, result of hard work and constant professionalism.

GDP Good Distribution Practice
The European Commission has revised the 1994 Guidelines regarding the Good Practice of Distributing medicinal products for human use (BDP/GDP), to reflect recent progress in the practice of the storage and distribution of medicinal products within the European Union, as well as the new regulations introduced by the Directive 2011/62/EU.
The wholesale distribution of medicinal products is an important activity in the integrated management of supplies.
Currently the distribution network of the medicinal products is ever more complex and involves many operators. The Guidelines establish appropriate tools to assist wholesale distribution in carrying out their operations and to prevent counterfeit medicinal products from entering the legal supply chain. Following the guidelines guarantees the monitoring of the distributing chain, maintaining the quality and integrity of the medicinal products.

The characterising elements of the GDP are relating to:
. Quality management;
. Risk management;
. Employee training, including health and hygiene requirements;
. Site and equipment management, cleaning and maintenance;
. A monitoring system to be implemented in all phases of: supplier assessment, client assessment delivery, storage and transport of the medicinal products;
. The management of claims, returns, the identification of counterfeit medicinal products and medicinal product recalls;
. The documentation (procedures / operating instructions / registrations) necessary for a correct management of distribution operations.

VIM G. Ottaviani Spa, for the second year running, on the 12/03/2021 obtained the reference from KIWA Cermet Spa for the Inspection Certificate relating to the distribution process of medicinal products intended for human use, certifying the conformity to the 5th November 2013 2013/C 343/01 Guidelines, with indisputable advantages, including:
. Offering major guarantees to clients regarding the capacity of the Organisation to respect the mandatory regulations and contractual agreements
. Demonstrating to the interested parties that the medicinal products are distributed implementing the Good Distribution Practices (GDP).
. Communicating that the implementation of Good Distribution Practices (GDP) is periodically checked by an independent third party.

UNI EN ISO 9001: 2015 Quality Management System (VIM)

GDP (Good Distribution Practice) certification release for the distribution process of medicinal products for human use, in compliance with the 2013 / C 343/01 Guidelines of 5 November 2013

Sustainability

Environmental sustainability: this aspect is linked to the protection of the environment: reduction of the environmental impact during processes, care of the use of natural resource, waste and recycling, saving in the management and maintenance in the selection of high quality, reliable and long lasting equipment/systems and components; plastic free (logoed bottles) Social sustainability: guaranteeing fairness and equality in the treatment of employees, banning every form of discrimination. This means creating safety conditions in the workplace and installing a sense of belonging for those who work.
. Respecting the national and worldwide sustainability laws and standards
. Intervening in production processes in order to make them more sustainable
. Safeguarding workers and employees
. Evaluating the impact the company has on the community