A pharmacopoeia is an officially issued digital manual containing directions for the preparation of medicinal products for humans and animals, and the requirements to be met. The purpose of the European Pharmacopoeia (Ph. Eur.) is to ensure that medicines, whether for humans or animals, are safe and of good quality. In the Netherlands, the Ph. Eur. law.

The Dutch delegation to the Ph. Eur. Commission acts as the Dutch Pharmacopoeia Authority (NFA). RIVM coordinates the scientific input for the European Pharmacopoeia from the secretariat, operating as secretary of the NFA, on behalf of the Minister of Health, Welfare and Sport. 

RIVM's activities 

RIVM carries out the following activities for the Dutch Pharmacopeia Authority: 

  • preparing meetings of the European Pharmacopoeia Commission (EFC);
  • planning, organising and reporting on the meetings of the Dutch delegation;
  • liaising with the pharmaceutical industry and other stakeholders in the Netherlands;
  • collating comments on new or revised Ph.Eur. texts from industry or other stakeholders from the Netherlands and forwarding text proposals;
  • nominating experts for various expert and working groups of the European Pharmacopeia;
  • supporting experts with laboratory work;
  • organising meetings for all Dutch experts;
  • evaluating the input of Dutch experts;
  • Acting as contact address for the European Pharmacopoeia Commitee in the Netherlands.

Dutch contribution to the European Pharmacopoeia

The Netherlands is compelled to contribute to the development and maintenance of the European Pharmacopoeia. For more information about what it entails, which organisations are involved and who represents the Netherlands, please visit the page of the Dutch contribution. Do you have topics to be discussed by the Dutch delegation? Please send them to farmacopee@rivm.nl no later than two weeks before the meeting date of the Dutch delegation's preliminary discussions.

EDQM 

The EDQM is the European Directorate (as part of the Council of Europe) for the quality of medicines and healthcare. The European Pharmacopoeia is one of the departments of the EDQM. It is responsible for the secretariat of the European Pharmacopoeia Committe (EFC) and for drafting the texts of the European Pharmacopoeia (Ph. EUR.) jointly with the relevant expert groups. Would you like to know more? 

Relevant links 

In this report, interviewed Dutch experts and specialists indicated to be generally satisfied with the state of affairs regarding the European Pharmacopoeia and the Dutch input. A number of recommendations for improvement have also been formulated (see Annex 6 of the report).