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RECOMMENDATIONS FOR THE PANDEMIC INFLUENZA PHARMACOVIGILANCE PLAN 4. 1. Content of the pharmacovigilance plan In the Pharmacovigilance plan the Applicant should describe - specific activities performed during a pandemic in relation to the collection collation assessment and reporting of spontaneous reports of adverse reactions see section 4. The pandemic influenza pharmacovigilance plan will terminate when it has been agreed with national competent authorities that it is no more necessary....
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What is pharmacovigilance plan form?
The pharmacovigilance plan form is a document that outlines the strategies and procedures for monitoring and reporting adverse drug reactions or side effects of a pharmaceutical product.
Who is required to file pharmacovigilance plan form?
Any pharmaceutical company or organization responsible for the marketing authorization and distribution of a pharmaceutical product is required to file the pharmacovigilance plan form.
How to fill out pharmacovigilance plan form?
The pharmacovigilance plan form must be filled out by providing details about the product, its manufacturer, and the pharmacovigilance system in place. It should also include information about the methods and frequency of monitoring adverse reactions and the reporting procedures.
What is the purpose of pharmacovigilance plan form?
The purpose of the pharmacovigilance plan form is to ensure the systematic monitoring and reporting of adverse drug reactions. It helps in identifying potential risks associated with a pharmaceutical product and implementing appropriate risk-management strategies.
What information must be reported on pharmacovigilance plan form?
The pharmacovigilance plan form requires the reporting of information related to the product, its marketing authorization holder, the procedures for monitoring adverse reactions, the reporting timeline, and the risk-management measures in place.
When is the deadline to file pharmacovigilance plan form in 2023?
The deadline to file the pharmacovigilance plan form in 2023 may vary depending on the regulations and guidelines of the specific regulatory authority responsible for pharmacovigilance. It is advised to refer to the relevant authority's documentation or consult with the regulatory agency for accurate information.
What is the penalty for the late filing of pharmacovigilance plan form?
The penalty for the late filing of the pharmacovigilance plan form can vary depending on the regulatory framework and jurisdiction. It may include financial penalties, restrictions on product marketing or distribution, or other regulatory actions. It is advisable to refer to the specific regulations and guidelines of the regulatory authority for accurate information regarding penalties.
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