E-Labelling Guidelines for Medical Products

False (B)

It would reduce environmental impact.

<p>natural</p> Signup and view all the answers

<p>Clear, concise, evidence-based, and relevant (D)</p> Signup and view all the answers

<p>Eliminate paper consumption = Preserve natural resources Reduce carbon footprint = Decrease environmental impact Enhance sustainability = Support eco-friendly practices</p> Signup and view all the answers

<p>False (B)</p> Signup and view all the answers

<p>To ensure accuracy and reliability in healthcare information.</p> Signup and view all the answers

<p>lifecycle</p> Signup and view all the answers

<p>Clear = Easily understood without confusion Concise = Free from unnecessary words Evidence-based = Backed by research and data Relevant = Applicable to the context of healthcare professionals</p> Signup and view all the answers

<p>Easier updates for safety information (B)</p> Signup and view all the answers

<p>False (B)</p> Signup and view all the answers

<p>text, audio, or video formats</p> Signup and view all the answers

<p>language</p> Signup and view all the answers

<p>E-labels = Allow faster updates for safety information Conventional paper labels = Cannot easily be updated once included Personalized information = Can be delivered in various formats User-friendly = Designed to accommodate the user's needs</p> Signup and view all the answers

<p>Regulatory actions from EDA (B)</p> Signup and view all the answers

<p>True (A)</p> Signup and view all the answers

<p>Recall of shipments</p> Signup and view all the answers

<p>regulatory</p> Signup and view all the answers

<p>Cancellation of approval letter = The disallowance of a product to be marketed Recall of shipments = The act of retrieving products that have been distributed Regulatory action = Official measures taken to enforce compliance Deviation from plans = An act of not following the established procedures</p> Signup and view all the answers

<p>To establish an electronic product information service (D)</p> Signup and view all the answers

<p>True (A)</p> Signup and view all the answers

<p>Electronic Product Information</p> Signup and view all the answers

<p>product</p> Signup and view all the answers

<p>Vaccine = A substance used to stimulate the production of antibodies Monoclonal antibodies = Antibodies that are made by identical immune cells Plasma derived medicinal products = Therapeutics made from human blood plasma Clinical Trials = Research studies to test the efficacy of a drug or treatment</p> Signup and view all the answers

<p>The URL generated by the company (D)</p> Signup and view all the answers

<p>True (A)</p> Signup and view all the answers

<p>Update the e-label immediately through the concerned units.</p> Signup and view all the answers

<p>process</p> Signup and view all the answers

<p>Submit request = Includes the URL Apply QR code = As approved by EDA Update e-label = Immediately after approval Propose e-labelling = No change in registration process</p> Signup and view all the answers

Information must be easily understood by healthcare professionals.

Messages should be brief and to the point for effective comprehension.

Healthcare information must rely on verified data and research.

Content must directly apply to the practices of healthcare professionals.

Information on medicines must be refreshed as new data and research become available.

Electronic labels that provide up-to-date information on products.

The ability to quickly disseminate updates and new information.

Tailored health info considering individual medical conditions.

Information can be shared in text, audio, or video formats.

Providing information in the patient's preferred language.

Labels that are electronically delivered instead of printed, reducing paper usage.

The amount of paper used for printing labels and documents.

Protecting resources like trees and water by using less paper.

Decreasing the total carbon emissions produced by paper usage and transportation.

The effect that our actions, like paper usage, have on the earth's ecosystems.

Electronic Product Information providing updates and approvals.

Medicinal products derived from biological sources, like vaccines.

Research studies testing biomedical or behavioral interventions.

Lab-made molecules that can mimic the immune system's ability.

Process of officially listing and approving biological products.

Consequences enforced by EDA for non-compliance with requirements.

Revocation of previously granted permission to market a product.

Withdrawal of products from the market due to violations like missing leaflets.

Marketing Authorization Holders must adhere to regulatory requirements.

Mandate to include informational leaflets in product packaging for compliance.

Applicants must use the QR code approved by EDA.

Applicants can propose e-labelling for new products during registration.

Any updates to a label must be approved before implementation.

E-labels must be updated quickly once label changes are approved.

The file containing all information for product registration including e-labelling.