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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....

How to fill out post-authorisation evaluation of medicines

How to fill out Post-authorisation Evaluation of Medicines for Human Use

1. Gather all necessary documentation related to the medicine, including clinical study results, adverse event reports, and patient usage data.
2. Review the regulatory guidelines provided by the relevant health authority for the Post-authorisation Evaluation (PAE).
3. Complete the application form provided by the health authority, ensuring all fields are filled out accurately.
4. Summarize the findings from post-marketing studies and any other relevant data that supports your evaluation.
5. Include an assessment of the benefit-risk balance of the medicine based on the collected data.
6. Submit the filled application along with the required documentation through the designated online portal or via mail, depending on the health authority’s instructions.
7. Monitor for any feedback or queries from the health authority and respond promptly to facilitate the evaluation process.

Who needs Post-authorisation Evaluation of Medicines for Human Use?

1. The Post-authorisation Evaluation of Medicines for Human Use is needed by pharmaceutical companies, regulatory authorities, healthcare professionals, and patients to ensure the ongoing safety and efficacy of medicines after they have been approved and marketed.

People Also Ask about

How long does it take to get EMA approval?

Typically, the EMA review process takes about 210 days, but this does not include the time the company may need to respond to questions or provide additional information. Therefore, it's not uncommon for the entire process to extend beyond a year.

Is EMA equivalent to FDA?

Whereas the FDA has a direct authority to approve the drug products, EMA can only evaluate submissions and provide non-binding recommendations to the European Commission (EC).

What is the role of the EMA?

The Environmental Management Agency is a statutory body responsible for ensuring the sustainable management of natural resources and protection of the environment, the prevention of pollution and environmental degradation, the preparation of Environmental Plans for the management and protection of the environment.

What is the EU equivalent of the FDA?

European Medicines Agency (EMA)

What is the EU Committee for Medicinal Products for Human Use?

The Committee for Medicinal Products for Human Use ( CHMP ) is responsible for the scientific evaluation of the application dossier on the quality, efficacy and safety (including environmental safety) of the medicinal product as part of the centralized marketing authorization procedure for new medicinal products.

How long does it take to get a decision from CHMP opinion to EC?

Following a CHMP opinion the European Commission takes usually its decision, a legally binding authorisation, after 67 days.

What is the European Agency for the evaluation of medicinal products evaluation of medicines for Human Use?

The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

For pdfFiller’s FAQs

What is Post-authorisation Evaluation of Medicines for Human Use?

Post-authorisation Evaluation of Medicines for Human Use refers to the processes and assessments that take place after a medicine has been authorized for sale, ensuring its continued safety, efficacy, and quality as it is used in the general population.

Who is required to file Post-authorisation Evaluation of Medicines for Human Use?

The manufacturers or marketing authorization holders of the medicines are required to file Post-authorisation Evaluation of Medicines for Human Use.

How to fill out Post-authorisation Evaluation of Medicines for Human Use?

To fill out Post-authorisation Evaluation of Medicines for Human Use, one must complete the designated forms with accurate and detailed information about the medicine's use in the market, including safety data and any adverse effects reported.

What is the purpose of Post-authorisation Evaluation of Medicines for Human Use?

The purpose of Post-authorisation Evaluation of Medicines for Human Use is to monitor the long-term safety and effectiveness of a medicine once it is on the market, identifying any potential risks or issues that were not apparent during clinical trials.

What information must be reported on Post-authorisation Evaluation of Medicines for Human Use?

Information that must be reported includes adverse event reports, changes in product formulation, any new safety information, updates from ongoing studies, and results from post-marketing surveillance.