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Pharmaceutical Product Registration and Pharmacovigilance - Some Important Concepts

April 25, 2012 | Comments: 0 | Views: 143

As you would expect, pharmacovigilance involves a heap of legislation directed at maintaining quality reporting and monitoring inside the medicines industry. Promoting permissions for medicinal products in more than one Member State within the EU needs drug companies to follow one of 3 techniques. Remember, extra state permissions enable products to be brought to the market in individual EU countries. Under this process, for any product holding nationwide permission, the regulatory agency of the European country in question is charged with safety assessment and monitoring for that product. This involves a single application, which if authorized, then bestows marketing authorisation for all of the countries in the European Union (and EFTA, meaning all EU nations, Iceland, Norway and Liechtenstein). For all products which meet the market through the centralized process, The European Commission becomes the responsible authority. This route is possibly open to all new or cutting edge pharmaceuticals and the only system for authorisation of biotechnology drugs.

Products containing novel substances reserved for the treating of major illnesses should be subject to the centralized process. It's a necessity for the appointing of a Rapporteur, and this may be the regulatory agency of one Member State and a Co-Rapporteur. Those 2 rapporteur states are then charged with directing safety assessment and monitoring for the product on and after presentation to the market). It does not need to be said that either the in-house pharmacovigilance team in the candidates company (or a high quality external team elected to provide pharmacovigilance services ) should be critical to guide the applicant smoothly through this stage. In brief, in this context, the process means the marketing authorisation granted by one Member of the EU is duly recognized and copied by all remaining Member States. Consequently, the other EU Members accept the first evaluation of the product itself. Often, a Member State can decide to raise challenges and meantime fail to recognize the first marketing authorisation. In such cases, the problem can be referred to the EMEA for debate among the parties concerned. Should that process fail, binding settlement will be imposed.

Again, the applicant's pharmacovigilance firms should invariably be on hand to give correct direction and recommendation for successful completion of any application.

This process can apply in situations where no marketing authorisation has been granted in any of the countries of the EU till now. Matching dossiers will be submitted to regulators in all EU countries in which a marketing authorisation will be required. The candidate is able to select the "Reference Member State" and formulates an initial assessment report inside 120 days.

The candidate must supply the report for all of the concerned Member States.

Those states can then approve the assessment or the application will continue into facilitation if there are concerns voiced. Should facilitation fail, there's then a binding settlement process which applies here. The Decentralised Procedure again is a step which should be undertaken under the expert instructions of the applicant's pharmacovigilance corporations. This quick guide should be useful in understanding the key ideas of product registration - the legal avenues by which products could be brought to the market in both single and multiple ECU nations.

This can be of help to you in handling your company's pharmacovigilance office, or with your external pharmacovigilance services supplier.

Jon Barton writes articles containing information on aspects of drug safety as an introduction to the topic for interested lay readers. More information on key components of pharmacovigilance work is provided by leading European pharmacovigilance services provider "PrimeVigilance" at their company website.

Source: EzineArticles
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