Post market monitoring requirements Not appropriate

(8) Post market monitoring requirements

Post market monitoring requirements Not appropriate.

Post market monitoring requirements Not applicable.

Post market monitoring requirements Not applicable.

Amendment 64 providing for increased surveillance in the first years following a marketing authorisation through the collection of data from groups of patients

Post marketing experience

Since 1998 post marketing studies have been performed as well as regular monitoring of adverse effects by FAQ system.

Post market monitoring requirements for the use of the food for human consumption

Post market monitoring requirements for the use of the food for human consumption Not required.

Adverse reactions from post marketing surveillance Additional adverse reactions reported during post marketing surveillance are listed below.

1.2 The EESC welcomes the recast of the current regulatory system by the Commission that goes beyond a mere simplification of the framework and puts in place more effective rules, strengthening the pre market approval procedures and in particular the post market surveillance.

There have been post marketing reports of anaphylactoid reactions.

What is important in this respect is that the directive introduces mandatory monitoring after the placing on the market of GMO products and a mandatory time limitation of maximum ten years for first time consent.

Spontaneous data A reanalysis of spontaneous data reported to the MAH up to 30 September 2001 found 1579 confirmed cases of rhabdomyolysis amongst 7,620 reports.

(18) Where appropriate and based on the conclusions of the safety assessment, post market monitoring requirements for the use of novel foods for human consumption should be introduced.

Monitor human rights cases, including sound statistical data.

sediments monitoring data)

Statistics Statistics( general Collection of statistical data Monitoring Workforce surveys

Follow up

Article 11 relates to the pharmacovigilance system, which has been established EU wide as a post marketing surveillance system for authorised medicinal products.

With the increasing support work necessitated by the entry into the market of a growing number of centrally approved products, post marketing activities including processing of variations (according to numbers forecast) and effective pharmaco vigilance monitoring are being handled effectively.

The following events were reported during post marketing experience of palivizumab

1.2 The EESC welcomes the proposed recast of the current regulatory system by the Commission that goes beyond a mere simplification of the framework and puts in place more effective rules, in particular on post market surveillance.

aquatic monitoring data)

(g) After being monitored, this data will need to be independently verified and then annually reported in an aggregated manner to the Commission and to the ship's flag state.

(b) To improve HIV AIDS epidemiological data by monitoring

all biological data requested to monitor the status of exploited stocks

biological data needed to monitor the status of exploited stocks

The company made additionally a commitment for post marketing surveillance.

a period after the medicine has been introduced on the market should also be subject to pharmacovigilance

a period after the medicine product has been introduced on the market should also be subject to pharmacovigilance

1.4 Health operators' role and responsibilities in the post marketing surveillance system should be made clearer, and steps should be taken to ensure appropriate dissemination of information and results arising from this surveillance.

1.4 Health operators' role and responsibilities in the post marketing surveillance system should be made clearer, and steps should be taken to ensure appropriate dissemination of information and results arising from this surveillance.

1.4 Health operators' role and responsibilities in the post marketing surveillance system should be made clearer, and steps should be taken to ensure appropriate dissemination of information and results arising from this surveillance.

Secondly, we have to introduce better supervision in order to get more reliable data.

On top of that, there is increased monitoring of personal data and of free communication.

A product should not have to be banned after it has been placed on the market because the product has actually shown itself to be harmful it should be banned before it is even placed on the market.

Balance sheet total ( CI ) Balance sheet total broken down according to the residence of the parent enterprise Balance sheet total broken down by legal status Data by product

that the existing monitoring networks, as specified in the monitoring plan contained in the notification, gathers the information relevant for the monitoring of the product and

that the monitoring networks as specified in the monitoring plan contained in the notification collect the information relevant for the monitoring of the product and

Countries and categories subject to the system of double checking surveillance

Countries and categories subject to the system of single surveillance

Therefore, the CHMP considered that the data provided was sufficient to include the therapeutic indication Infections of the bones and joints in Ciprofloxacin Marketing Authorisations, and noted that the SPC should give a clear message on the need for co administration with appropriate antibacterial agent(s).

(30) It is necessary to introduce, where appropriate and based on the conclusions of the risk assessment, post market monitoring requirements for the use of the genetically modified foods for human consumption and for the use of the genetically modified feed for animal consumption.