REACH24H Consulting Group

Value in Compliance

Displaying items by tag: DMF restriction

According to US Federal Administrative Law, there is a Drug Master File (DMF) must be provided for pharmaceutical ingredient entering into United States. It is a document that provides detailed interpretation of a drug manufacture process, which would help FDA to have a comprehensive understanding of the manufacturing plant. The latter will issue certification to allow the applying products to place on US market.

Our Service Includes:
>> Compilation and delivery of DMF to FDA
>> Acquisition of DMF distribution number and NDC registration number
>> DMF annual update
>> Help company to prepare materials for obtaining FDA certification
>> Assist company to confront regular random inspection

About REACH24H
REACH24H Group provides product stewardship & regulatory compliance service for global customers from its three offices – Ireland, Canada and China, assisting international companies to comply with global chemical regulations including the EU REACH, China new chemical substance notification, Global GHS, USA TSCA, etc. REACH24H in-house team consists of global-regulatory experts, toxicologists, environmental risk assessors, chemical engineers and IT software development engineers to provide cost-effective access to the marketplace for the clients. REACH24H Consulting Group is also the sub-company of Centre Testing International Corporation (CTI) , a publicly traded company on the Chinese Stock Exchange(300012.SZ). CTI is China’s leading product testing, inspection, certification, and consulting firm, providing comprehensive services for virtually all consumer products. For more information on REACH24H, please Contact us or visit About us.

Published in DMF & FDA

EU Commission to ban use of DMF in articles for content greater than 0.1 mg/kg

 

18 May 2012

 

The European Commission has published on 15 May 2012 an amendment to REACH Annex XVII, ordering that EU would ban articles containing dimethylfumarate (DMF) content greater than 0.1 mg/kg from 1 June 2012.

Published in Europe

7 February 2012

 

The European Commission has announced an extension to the Regulation preventing the sale of products containing the biocide dimethylfumarate (DMFu).

Published in Europe

EU Commission Publishes Draft Dimethylfumarate Restriction

 

Oct 13, 2011

 

On October 6, 2011, the European Union Commission published  a draft Regulation amending Annex XVII of REACH to include a restriction on dimethylfumarate (DMF) on the EU comitology register. The draft, which is expected to be adopted at the REACH Committee’s November meeting, backs the compiled opinions of ECHA’s Risk Assessment and Socio-Economic Analysis Committees.

 

It suggests that the substance, which has been used as an anti-moulding agent and resulted in one of the largest chemical-related compensation claims in the UK last year, will not be used in articles or any parts thereof in concentrations greater than 0.1mg/kg and any articles, or components of articles containing DMF in concentrations greater than 0.1mg/kg shall not be placed on the market.

 

If it is adopted, the Regulation will enter into force on the 12th day following its publication in the EU Official Journal.

 

Published in Europe
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