European Union tcc, monografias, monografias prontas, dissertação de mestrado e tese de doutorado and list entries Share
The Committee on Herbal Medicinal Products (HMPC) compiles and assesses scientific data on herbal substances, preparations and combinations with a focus on safety and efficacy. This work supports the harmonisation of the European market: national competent authorities are able to refer to one unique set of information on a herbal substance or preparation when evaluating marketing applications.
European Union tcc, monografias, monografias prontas, dissertação de mestrado e tese de doutorado
A European Union (EU) herbal monograph (formerly known as Community herbal monograph) contains the HMPC’s scientific opinion on safety and efficacy data about a herbal substance and its preparations intended for medicinal use. The HMPC evaluates all available information, including non-clinical and clinical data, but also documented long-standing use and experience in the EU.
EU monographs provide all information necessary for the use of a medicinal product containing a specific herbal substance or preparation:
EU monographs are divided into two sections:
Well-established use (marketing authorisation) Traditional use (simplified registration)
Demonstrated with sufficient safety and efficacy data Accepted on the basis of sufficient safety data and plausible efficacy
Each herbal preparation is assessed individually as information available may vary from one preparation to another. This is why some preparations will appear in the well-established use section of the monograph and others will be in the traditional use section. If data are insufficient, some preparations might not be included.
Using EU herbal monographs for applications
A final EU tcc, monografias, monografias prontas, dissertação de mestrado e tese de doutorado can be used in application reference material by a marketing authorisation applicant (well-established use part) and by a traditional-use registration applicant (traditional-use part).
Final monographs are taken into account by Member States when examining an application. While Member States are not obliged to follow the monographs, any decision not to accept the content of a monograph as adopted by the HMPC should be duly justified taking into account their important role in bringing harmonisation to this field and to facilitate the use of the simplified registration procedure.
When EMA publishes an HMPC opinion, this includes the monograph, the supporting assessment report and divergent positions of individual HMPC members if the monograph was not adopted by consensus (see article 7 of the HMPC PDF iconRules of procedure tcc, monografias, monografias prontas, dissertação de mestrado e tese de doutorado).
For more information on the use of EU monographs in procedures for placing a herbal medicinal product on the market in a particular Member State, refer to the relevant national competent authority.
Finding EU herbal monographs
To view all EU herbal monographs, or to browse for existing EU herbal monographs and supporting documents by herbal substance, go to Herbal: European Union herbal monographs.
European Union list entries
To complement traditional-use monographs on herbal substances, the HMPC gradually develops the European Union list (formerly known as Community list) through ‘list entries’.
Unlike EU herbal tcc, monografias, monografias prontas, dissertação de mestrado e tese de doutorado, EU list entries are legally binding on applicants and national competent authorities in the Member States.
Draft list entries are developed by the HMPC, but the final list entries are adopted and published by the European Commission.
Using EU list entries for applications
If applicants for traditional use registration can demonstrate that their proposed product and related claims in the application comply with the information contained in the EU list, they will not need to provide evidence of its safe and traditional use tcc, monografias, monografias prontas, dissertação de mestrado e tese de doutorado.
National competent authorities cannot require additional data to assess the safety and the traditional use of the product.
List entries are the basis of a medicinal product’s summary of product characteristics (SmPC).
This monograph follows the presentations and discussions at the International Conference: Advancing knowledge on tobacco products, held in Oslo, Norway 9-11 February, 2000. At the conference it tcc, monografias, monografias prontas, dissertação de mestrado e tese de doutorado.
was recognized that a central goal of those assembled was to build scientific and epidemiological evidence for the effective and appropriate regulation of tobacco products. Tobacco products are not currently well-regulated; where good regulations do exist they are not well implemented.
Rather than a straightforward reproduction of individual papers, this monograph presents a synthesis of the issues raised, grouped as topics. The aim of this was to bring together the various points of scientific evidence, as well as opinion, with information on regulations already in place to line up with those proposed. This approach shows clearly the areas where detail is lacking and this should be viewed as an invitation to readers to contribute further to the topic.
Part 1 provides an epidemiological review of tobacco use as a cause of
disease and death, looking at the global trends, at issues such as environmental tobacco smoke, and reviewing dose-response relationships tcc, monografias, monografias prontas, dissertação de mestrado e tese de doutorado.
Part 2 contains information on the technical aspects of tobacco products, establishing cigarettes as engineered products, reporting on the various new forms of nicotine-providing devices, and centrally, exploring both the history of the machine-testing process set up by the Federal Trade Commission (FTC) and the International Organization for Standardization (ISO), and the arguments against its continued use on public health grounds, considering, for example, the impact of compensating mechanisms in people’s smoking behaviours and how those invalidate the tests. The issues of “low-tar” and “light and mild” branding of products, the role played by nicotine in smoking, and the related issues such as the marketing position developed tcc, monografias, monografias prontas, dissertação de mestrado e tese de doutorado.
on so-called “light cigarettes” are covered. This part also explores the issue of the other harmful ingredients in cigarettes and cigarette smoke beyond tar, nicotine and carbon monoxide, and raises points to substantiate the argument for careful research into the additives to tobacco and regulation of them.
Part 3 looks at the overall picture of current tobacco product regulation highlighting the areas which need reform. This includes details of the regulatory forms in use, and problems with their implementation, with proposals for key elements such as ingredient disclosure to be included in new regulatory frameworks. There is a summary of current international tobacco product regulation and a specific analysis of the proposed future directions in tobacco control in the European Union. This part also describes the status of international collaboration, WHO’s role and the scientific resources available. Parallel examples in the pharmaceutical field are given, and an account of the tobacco industry’s opposition to measures which recognize tobacco use as harmful to health tcc, monografias, monografias prontas, dissertação de mestrado e tese de doutorado.
The recommendations made at the conference are reproduced in full in Annex 1 and are also inserted at the relevant points throughout the text.