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European Medicines Risk Management Plan (EU-RMP) template Guidance (on drugs restoring the parenteral route of administration, dose calculation) and instructions. If the correct route of administration of the products has a potentially life-threatening danger, you should consider how to avoid these errors in the route of administration. When the conventional route of administration of drugs is also a dangerous route for administering other drugs, it is particularly important to consider this point. It's necessary to discuss the different specifications of the same drugs, asking about and usually contrasting the visual difference between the use of other drugs or physical differences. When visually impaired people are likely to use drugs, it's especially important to consider the potential for medication errors; one should consider the child’s accidental ingestion; discussions should occur during product development and confirm any medication error, including information on medication errors, possible causes of medication errors, and potential treatment methods. Medication errors should have been considered in the final product design, including drug indications. After the listing of the drugs, if medication errors lead to a significant increase in adverse reactions, they should be discussed in the updated EU-RMP, and methods to reduce medication errors should be proposed. For unconventional risk minimization measures intended to address confirmed or potentially significant risks, the risk minimization plan shall provide the following (Table 16).
In Table 16, EU-RMP unconventional risk minimization measures to be taken by routine risk minimization action (i.e., producing a brief description of unconventional summary of product characteristics product information, brochures, and packaging) (SPC), the instructions to achieve risk minimization measures include risk minimization action (such as a goal and principle of teaching prescribers, pharmacists, and patients two risk minimization measures, sterile materials or training program, limit the drug test the risk of the e4 ff_, measures the success of products to obtain Plan) of the standard 4 evaluation cycle unconventional goal and principle of risk minimization action l 2 ...... 2 risk minimization measures test risk minimization measures the success of the standard 4-cycle evaluation of five risk management plan summary table (Table 17).
Table 17 provides a summary of the Risk Management Plan concerning security issues, pharmacovigilance operations (conventional and unconventional), minimize the risk of operation (conventional and unconventional), security issues such as: such as: l conventional pharmacovigilance lSPC4.3 in, contraindications 2 is investigation of a warning the purpose 2SPC4.4 in drug use of educational materials to control the sale of security issues 2 6 6 June 2009 pharmacovigilance Chinese Journal of PharmacOvigllance Vo1.6, No. 6 June, 20 096 contacts of the EU risk management plan, including name, position, qualification, and signature.
Appendix 7 includes a catalog of attachments with attachment content, Annex 1 current (or the EU risk management plan was originally to be taken) Feature Summary and Packaging Labels Attachments being carried out and has completed clinical trials Outline of Annex 4 ongoing and has completed the outline of the drug epidemiological studies Annex 5 pharmacovigilance plan to be taken and the ongoing research program Annex 6 available to the annex to the report of other support Annex 8 suitable for product risk education program details.
In Annex 1: EU Risk Management Plan and Pharmacovigilance in common. EU risk management templates: through centralized drug approval process, there is a need to provide the electronic version of the data elements. In EudraVigilance, the reports of suspected adverse reactions are an essential part of the EU Risk Management Plan, monitoring identified risks or potential risks for drugs approved via the centralized procedure. To allow EudraVigilance to monitor identified risks or potential risks, these elements should be submitted in electronic form. A template for collecting the relevant data elements is provided on the EudraVig-ilance website (http://eudravigilance.emea.europa.eu), issued by the EU-9A volume database access with the same layout as macros that can be used by Microsoft.
Drugs approved via the centralized procedure should initially submit the EU-RMP according to the template required to submit the completed file; data elements collected according to the template should be submitted in each update of the EU-RMP. The forms in Appendix 2, 5.6, 7, 8 are sample forms. Appendix 3 describes ongoing and completed clinical trials. Appendix 4 pharmacoepidemiology study describes (translated: http://www.emea.europa.eu/pdfs/human/eu-leg/19263206en.pdf).
