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6 June 2013 EMA×349321×2013 Information and Communications Technology Electronic Application Form Data Exchange Standard 3.0 Supplementary Specification Annex 2 Variations Form v.1.9.1 7 West ferry
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How to fill out des annex 2 variationsv191
How to fill out DES Annex 2 Variationsv191:
01
Start by entering the relevant information at the top of the document. This includes the product name, dosage form, strength, and the applicant's details.
02
Next, carefully review each section of the form and provide the required information. This can include the type of variation being submitted, the regulatory basis for the change, and the proposed effective date. Be sure to follow the instructions provided for each section to ensure accurate and complete submission.
03
In section A, provide a brief description of the variation and its purpose. This should include the rationale for the change and any supporting documentation or references.
04
Section B requires detailed information about the quality aspects of the variation. This may include changes to the manufacturing process, changes in the composition or specification of the product, or updates to the packaging. Provide all the necessary details and any supporting data.
05
In section C, outline any proposed changes to the product information or labeling. This can include updates to the package leaflet, the summary of product characteristics, or any additional labeling changes. Include all the necessary information and refer to relevant guidelines or regulations.
06
Section D focuses on nonclinical aspects, such as changes to the pharmacokinetic properties, or the introduction of new impurities. Provide a comprehensive overview of the proposed changes and their implications.
07
Similarly, section E deals with clinical aspects of the variation. If there are any changes to the clinical study data, patient population, or the therapeutic indication, provide all the necessary details and supporting evidence.
08
Section F requires information regarding the environmental risk assessment, if applicable. Specify any potential environmental impact resulting from the proposed variation and any necessary risk management measures.
09
Finally, sign and date the form, and ensure that all the required attachments and supporting documents are included with the submission.
Who needs DES Annex 2 Variationsv191:
01
Pharmaceutical companies or manufacturers seeking to submit variations to a medicinal product falling under Directive 2001/83/EC and Regulation (EC) No 726/2004.
02
Regulatory affairs professionals or consultants responsible for preparing and submitting variation applications to the relevant competent authorities.
03
National regulatory authorities or agencies responsible for reviewing and approving variation applications in accordance with the applicable regulations and guidelines.
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What is des annex 2 variationsv191?
DES Annex 2 Variationsv191 is a regulatory form used to report changes or variations in drug product information.
Who is required to file des annex 2 variationsv191?
Marketing authorization holders are required to file DES Annex 2 Variationsv191.
How to fill out des annex 2 variationsv191?
DES Annex 2 Variationsv191 can be filled out electronically through the designated regulatory authority's portal.
What is the purpose of des annex 2 variationsv191?
The purpose of DES Annex 2 Variationsv191 is to ensure transparency and accuracy of drug product information.
What information must be reported on des annex 2 variationsv191?
Information such as changes in labeling, packaging, formulation, or manufacturing process must be reported on DES Annex 2 Variationsv191.
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