In this context, Pharmacovigilance aims to ensure that patients, healthcare professionals and competent authorities have all relevant information about the benefits and risks of medicinal products to make informed decisions about their use.
Our responsibility as a pharmaceutical company is to monitor the safety and efficacy of the medicines we produce, distribute and/or market. Our commitment is to actively gather all adverse effects associated with the use of our medicines, analyse and submit them, where applicable, to regulatory authorities.
The MEDINFAR Group also has cosmetic products, food supplements and biocides in its portfolio. The Pharmacovigilance Unit (Medical Department) manages the vigilance of these products as well as medicines.
Similarly, with regard to veterinary medicines, MEDINFAR Sorológico is responsible for systematically gathering suspicions of harmful and involuntary reactions in animals and, possibly, in humans, when exposed to medicines and other veterinary products used in animal husbandry and health.
Following the Marketing Authorisation (MA), veterinary medicinal products, including immunosuppressant drugs, veterinary products and veterinary biocides, must continue to meet the requirements of quality, efficacy and safety and provide an acceptable balance between benefits and risks.
Pharmacovigilance & Vigilance of other products
An adverse effect is also called an "adverse effect or event", "adverse reaction" or side effect (a fairly common term). This term is used to describe any adverse occurrence observed in a patient or consumer when taking a medicinal product. They may or may not be caused by the medicinal product, but it is important to report it and try to understand whether there is a causal relationship.
Any medicine, however safe and effective, can cause adverse effects. In other words, a medicinal product is assessed and approved by competent authorities whenever its benefits outweigh the risks associated thereto for the treatment or prevention of a disease.
Reporting of adverse effects allows for the detection of safety alerts, which can lead to:
- Better knowledge of the drug's safety profile, reinforcing the benefit/risk balance;
- Detection of new adverse drug reactions;
- Update of the drug safety information, such as the Summary of Product Characteristics (RCM) and Package Leaflet.
Anyone can report adverse effects, whether they are healthcare professionals or not.
Adverse effects should be informed to your doctor or pharmacist, as not all changes that are felt when a medicine is taken are a side effect of that medicine. It is important to contact a healthcare professional, who will analyse the situation and make appropriate recommendations as to whether or not intake of the medicinal product should be continued and, if so, how to report any suspected adverse reactions.
Cosmetovigilance is aimed at monitoring and disseminating cosmetic safety information, allowing for the monitoring of adverse effects associated with the use of cosmetic products available on the market. Thus, it includes reporting and collection of information on adverse effects derived from the use of cosmetics; recording, evaluation and analysis of information relating to such adverse effects, with the ultimate aim of preventing their repetition; conducting safety studies arising from the use of cosmetics; and the performance and follow-up of corrective actions, if necessary.
A cosmetic product is defined as "any substance or mixture intended to be used on the external parts of the human body (skin, hair, nails, lips and external genital organs), the teeth and mucous membranes of the mouth. Cosmetics are exclusively or mainly aimed at cleaning, perfuming, changing the appearance, protecting, keeping the aforementioned body parts in good condition or correcting body odours" (pursuant to Regulation (EC) nº 1223/2009 of November 30). Cosmetic products shall not harm human health when used under normal or reasonably foreseeable conditions of use. However, even in accordance with such requirements, adverse effects associated with the use of a cosmetic product may occur.
It is an adverse reaction to human health attributed to the normal or reasonably foreseeable use of a cosmetic product.
It is an adverse effect resulting in temporary or permanent functional incapacity, disability, hospitalisation, congenital abnormalities, and immediate risk to life or death.
Food supplements are deemed foods that are intended to complement and/or supplement a normal diet, and should not be used as substitutes for a varied diet. Food supplements are concentrated sources of certain nutrients or other substances with nutritional or physiological effect, on their own or combined, sold in pre-packaged and dosed form (Regulation (EC) No. 178/2002).
In addition, food supplements may carry a risk of adverse reactions. Hence, the collection and systematization of information on adverse reactions is of utmost importance in terms of food safety and public health.
You can also report directly to the Portuguese Food and Veterinary Authority (DGAV) by using a form sent to the Directorate of Nutrition and Food Services of DGAV (firstname.lastname@example.org), available on this website.
Biocidal products, according to Regulation (EU) No. 528/2012 are defined as:
- “any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action;”
- “any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.”
- Biocidal products also carry the risk of adverse reactions. Thus, the collection and systematization of information related to adverse reactions is of the utmost importance.
You can also report directly to the Portuguese Food and Veterinary Authority (DGAV) - National System of Veterinary Pharmacovigilance, to the following contacts:
Direct number: 217 808 221 (business hours)
General phone number: 213 239 500 (business hours)