Belgian Centre for Pharmacovigilance (BCPH)

The Belgian Centre for Pharmacovigilance for medicines for human use (BCPH) is responsible for coordinating the different tasks related to pharmacovigilance.

BCPH is part of a European network of pharmacovigilance, called Eudravigilance.

BCPH bears part of the responsibility for evaluating pharmacovigilance data for medicines that are authorised at the end of the European procedure.

There is direct collaboration in terms of pharmacovigilance between the different Member States in the European Economic Space via the Pharmacovigilance Working Party, representing all the Member States of the European Medicines Agency based in London.

Whenever a serious pharmacovigilance problem arises in Europe or elsewhere:

- a European procedure allows the medicine to be evaluated globally,

- a restricting decision can be made for all the Member States,

- the information can be conveyed more quickly.

This network, which enables reports on undesirable effects on a European level to be transmitted electronically, helps to speed up the detection, evaluation and measure-taking that are necessary to respond to safety fears when using medicines, from their concept to the time they are used by the patient.

 

The main tasks of BCPH are as follows:

 - collecting and evaluating periodic pharmacovigilance reports

- collecting and evaluating reports about the safety of patients during clinical trials involving medicines authorised in Belgium,

- collecting and evaluating individual reports about undesirable reactions conveyed by healthcare professionals and marketing authorisation holders,

- participating in European pharmacovigilance activities,

- distributing information about pharmacovigilance to healthcare professionals and the general public,

- implementing the proposed measures following the evaluation of the pharmacovigilance data,

- managing renewal files for medicines authorised under the national procedure - see circular 490 (in French) + renewal request form (in French) + Guidance on the e-submission of renewal of a national Marketing Authorisation .

- pharmacovigilance inspections for prevention and repression

- evaluating risk management plans and pharmacovigilance systems

 

Last updated on 11/12/2008