PHV - HUMAN USE
Vigilance of biocides
According to the Biocidal Products Regulation 528/2012 (BPR), a biocidal product is:
- “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.”
Biocaidal product can also be responsible for adverse reactions and therefore, this information should be collected.
How to report?
Notifications can also bem ade directly to the national Competent Authority, Direção Geral de Saúde, https://www.dgs.pt/saude-a-a-z.aspx?v=%3d%3dBAAAAB%2bLCAAAAAAABABLszU0AwArk10aBAAAAA%3d%3d#saude-de-a-a-z/biocidas
The purpose of Cosmetovigilance is to monitor and disseminate cosmetics’ safety information, allowing the collection and detection of undesirable effects associated with the use of cosmetic products available on the market. Therefore, the collection, assessment and analysis of undesirable effects aims to ensure the protection of health of cosmetics users and the reduction of the likelihood of reoccurrence of such events.
A cosmetic product is defined as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition” (according to the European Legislation).
Cosmetic products should not harm human health when used under normal or reasonably foreseeable conditions of use. However, even in accordance with the required requirements, undesirable effects associated with the use of a cosmetic product may occur.
What is an undesirable effect?
An undesirable or adverse event is defined as any human adverse health event which is voluntarily reported by consumers, healthcare professionals, Competent Authorities, and any other individuals to have occurred during or after normal or reasonably foreseeable use (exclude misuse and abuse)3« of a cosmetic product.
What is a serious undesirable effect?
A serious undesirable effect means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death.’
How to report?
Notifications can also be made to the national Competent Authority, INFARMED, I.P. through a form available in https://www.infarmed.pt/web/infarmed/profissionais-de-saude/vigilancia-de-produtos-cosmeticos
Vigilance of Food supplements
Food supplements are defined as foodstuffs that are meant to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form and other similar forms of solids, liquidis and powders designed to be taken in measured small unit quantities, where nutrients could be vitamins, minerals, herbal extracts and other ingredientes (as per EU legislation).
There is also a risk of adverse reactions with food supplements and therefore, the collection and systematization of information on adverse reactions is of the utmost importance in terms of food safety and ultimately to protect public health.
How to report?
The notifications can also de made to the national Competent Authority, Direção-Geral de Alimentação e Veterinária (DGAV) using a form (available in http://www.dgv.min-agricultura.pt/portal/page/portal/DGV/genericos?generico=10128953&cboui=10128953) that should be sent to Direção de Serviços de Nutrição e Alimentação(email@example.com).
Following the marketing authorisation, veterinary medicinal products, including immunologicals, veterinary products and veterinary biocides, must continue to meet the quality, efficacy and safety requirements and provide an acceptable benefit/risk balance. Therefore, Medinfar Sorológico is responsible for systematically collecting suspected adverse reactions (harmful and involuntary) that occur in animals and possibly in humans when exposed to medicines and other veterinary products.
How to report?
In addition, all reports can be send to the National Competent authority - Direção Geral de Alimentação e Veterinária (DGAV) - Sistema Nacional de Farmacovigilância Veterinária, to the contacts mentioned in http://www.dgv.minagricultura.pt/portal/page/portal/DGV/genericos?actualmenu=198566&generico=17499&cboui=17499