Lexique

Defining Health Product

Defining Health Product

The National Security Agency of Medicines and Health Products (Agence Nationale de Securite du Medicament et des Produits de Sante) collectively referred to health products the following categories:

– “Drugs,

– Blood-derived drugs,

– Narcotics and psychotropic

– Vaccines

– Cellular products for therapeutic purposes,

– Gene therapy medicinal products,

– Labile blood products,

– Ancillary therapeutic products,

– Tissues and organs of human or animal origin

– Medical devices

– Diagnostic medical devices in vitro,

– Cosmetics,

– Products tattoo

– Other products and substances.”

Drug

Article L.5111-1 code of public health, as amended by Law No. 2007-248 of 26 February 2007 containing various provisions adapting to Community law in the field of medicine defines the drug as follows: “We medicinal product is any substance or composition presented for treating or preventing against human and animal diseases, as well as any substance or compound that can be used in humans or animals or that can be administered to them, view to making a medical diagnosis or to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action. “

Dietary supplement

According to Article 2 of Directive 2002/46 / EC of the European Parliament and of the Council (Eur-lex, the European Parliament and Council, 2002): “The term dietary supplements, foods with the aim of supplementing the diet 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, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, bottles with dropper and other similar forms of liquids and powders designed to be taken in measured small unit quantities “.


The General Message

Trying to classify health products is more complex than expected. In France, it is the National Security Agency of Medicines and Health Products who is responsible.

What it means for Health Professionals

Every healthcare professional should have a guide on the effectiveness and side effects of all health products. This is far from the case today including medical devices and non-drug interventions as will be related in the Blog in © Health.

What it means for Researchers

The procedures for demonstrating the efficacy of health products evolve (Rapior, 2013). Ambiguity may exist to the general public between the obligation of the manufacturer of a health product or medical to maintain CE manufacturing standard to demonstrate the effectiveness of the health system.

What it means for Policymakers

The term medical device is very broad. According to the European Directive 93/42 / EEC and taken over by the National Security Agency of Medicines and Health Products (MSNA), it can be a matter of “any instrument, apparatus, appliance, software, material or other article, used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and / or therapeutic purposes and necessary for the proper functioning of it. “The medical device is intended for use in humans for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, compensation for an injury or handicap, study replacement or modification of the anatomy or of a physiological process, control of the design. This field is extremely large.


Reference

Agence Nationale de Sécurité du Médicament et des Produits de Santé (2013). Site web.

Eur-lex (2009). Directive 2000/13/CE du Parlement européen et du conseil relative au rapprochement des législations des Etats membres concernant l’étiquetage et la présentation des denrées alimentaires ainsi que la publicité faite a leur égard. Journal Officiel de l’Union Européenne, version consolidée, août 2009.

Eur-lex (2002). Directive 2002/46/CE du Parlement Européen et du Conseil relative au rapprochement des législations des Etats membres concernant les compléments alimentaires. Journal Officiel des Communautés Européennes, L183/51, 10 juin 2002.

Eur-lex (2007). Rectificatif du règlement CE N° 1924/2006 du Parlement Européen et du Conseil du 20 décembre 2006 concernant les allégations nutritionnelles et de santé portant sur les denrées alimentaires. Journal Officiel de l’Union Européenne, janvier 2007.

Légifrance (2008). Loi n°2007-248 portant diverses dispositions d’adaptation au droit communautaire dans le domaine du médicament. Journal Officiel de la République Française, article L5111-12, version consolidée décembre 2008.

Rapior S (2013). Les produits de santé (pp.35-49). In Ninot G (Ed.). Démontrer l’efficacité des interventions non médicamenteuses : Question de points de vue. Montpellier : Presses Universitaires de la Méditerranée (PULM).


To reference this Blog en Sante © article

Ninot G (2014). Definition of health product. Blog en Sante, L27.

© Copyright 2014 Grégory Ninot. All rights reserved.