Transposition of Directive 2010/84/EU and Regulation 1235/2010/EU on Pharmacovigilance

The views of the public and interested parties are sought on draft regulations transposing EU Directive 2010/84/EU and EU Regulation 1235/2010/EU on Pharmacovigilance. This legislation will be transposed into Irish law during July 2012.

Pharmacovigilance is the science of the detection, assessment, understanding and prevention of Adverse Drug Reactions (ADRs) and related activities to improve the safety of medicines.

Transposition of the Pharmacovigilance Directive necessitates amendment to the Medicinal Products (Control of Placing on the Market) Regulations 2007 and the Medicinal Products (Control of Manufacture) Regulations 2007.

The revised legislation has several key aims as follows:

  • To strengthen and rationalise the current system for monitoring the safety of medicines,
  • To clarify the tasks and responsibilities for all parties involved in the pharmacovigilance system (pharmaceutical company placing product on the market, Irish Medicines Board and European Medicines Agency),
  • To improve communication and transparency on medicine safety so that health professionals and the public have access to better information on medicine safety issues,
  • To improve decision-making procedures in order to ensure consistent decisions on medicines safety issues and prevention of unnecessary patient exposure to risks,
  • To involve stakeholders in pharmacovigilance, including through direct patient reporting of suspected adverse drug reactions,
  • enhancement of companies’ pharmacovigilance systems and to ensure the proactive and proportionate collection of high-quality data relevant to the safety of medicines,
  • To strengthen the systems for collecting information and improve cooperation between Member States so that medicines safety issues can be identified and acted on sooner.

It should be noted that the purpose of this consultation is to obtain feedback from stakeholders on the proposed transposition in order to ensure that it appropriately implements the provisions of the Directive. As part of this consultation it is not possible to change the policy agreed in the Directive.

Comments in relation to this consultation should be sent to by 5pm on Fri July 6th 2012.

Draft for consultation – Medicinal Products (Control of Manufacture) (Amendment) Regulations 2012 (PDF)

Draft for consultation – Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2012 (PDF)