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DOSSIER D5 To Delist Medicine(s)/ Indication from the MOH Medicines FormularyBACKGROUND This form is to be used for submission of a proposal to delist any medicine/indication from the MOHMF. Any relevant
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How to fill out annex xv restriction report

01
Gather all relevant information and data related to the substance.
02
Identify the hazardous properties and potential risks associated with the substance.
03
Assess the potential impact of the substance on human health and the environment.
04
Fill out the necessary sections of the annex xv restriction report form, including detailed information on the substance, its uses, and the proposed restrictions.
05
Submit the completed annex xv restriction report to the appropriate regulatory authorities for review and approval.

Who needs annex xv restriction report?

01
Companies or individuals who manufacture, import, or use substances that are subject to restrictions under Annex XV of the REACH regulation.
02
Regulatory authorities responsible for enforcing restrictions on hazardous substances in the European Union.

What is Annex XV Restriction Report for D4, D5 and D6. Form?

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The Annex XV Restriction Report is a document required under the REACH regulation (EC 1907/2006) in the European Union, which assesses substances that may pose a risk to human health or the environment. It outlines proposals for restricting the use of certain substances in specific applications.
Manufacturers, importers, or downstream users of substances deemed to require restriction under the REACH regulation are required to file an Annex XV Restriction Report.
To fill out an Annex XV Restriction Report, one must follow the guidelines provided by the European Chemicals Agency (ECHA), ensuring to include all necessary information on the substance's properties, uses, risks, and proposed restrictions.
The purpose of the Annex XV Restriction Report is to provide a comprehensive assessment of risks associated with specific substances and to propose necessary regulatory actions to restrict or prohibit their use.
The report must include details such as the identity of the substance, classification and labelling, uses, exposure scenarios, risk assessment, and proposals for restrictions along with justification.
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