Danish Pharmacopoeia Commission and subcommittees

Updated 17 February 2021

Tasks

The primary tasks of the Danish Pharmacopoeia Commission and the four subcommittees are to give advice to the Danish Medicines Agency in matters concerning the quality of medicines. The commission and subcommittees also offer advice in connection with the work with the European Pharmacopoeia (Ph. Eur.) for the preparation of guidelines on the quality of medicines in the EU and in the ICH collaboration between the EU, USA and Japan. The Danish Pharmacopoeia Commission and subcommittees do not have decision-making powers, but make recommendations to the Danish Medicines Agency based on their discussions.

The Danish Pharmacopoeia Commission consists of the four chairs of the subcommittees. It holds two meetings a year, one of which is joined by the Danish members of groups of experts and working parties that handle the elaboration and revision of Ph. Eur. texts and monographs. The meetings of the Danish Pharmacopoeia Commission usually concern the mutual exchange of information of the work of the subcommittees and the Ph. Eur. groups of experts and working parties.

The four subcommittees generally process all scientifically relevant topics specific to the committees’ areas of expertise. In relation to the Ph. Eur., the committees primarily process the proposed texts and monographs that have been submitted for consultation in Pharmeuropa concerning:

  • Biology Subcommittee: Biological raw material and medicinal products, including vaccines, allergenic products and blood products.
  • Pharmacy Subcommittee: General monograph and texts concerning the manufacture of medicines.
  • Pharmacognosy Subcommittee: Plant medicines.
  • Chemistry Subcommittee: General and specific monographs and texts concerning chemical raw materials and medicines.
The members are composed of representatives from the pharmaceutical industry, universities and other institutions that can offer their experience and detailed knowledge on the development and technical quality of raw materials and finished products within the manufacture of medicines.
 
The frequency of meetings is usually four meetings a year, and the meetings are scheduled to accommodate the deadlines for submitting consultation responses to texts in Pharmeuropa. The meetings are also joined by representatives from the Danish Medicines Agency’s licensing division, control division and the inspection division as relevant.
The comments of the committees (including those from the pharmaceutical industry) are gathered and sent as a combined Danish contribution to the Secretariat of the European Pharmacopoeia via the National Pharmacopoeia Authority (NPA)

Recruitment of members for the term January 2020 to December 2023

The members of the Danish Pharmacopoeia Commission and its four subcommittees are appointed by the Ministry of Health for terms of four years. The current period runs from 1 January 2020 to 31 December 2023.

Anyone can nominate members, and self-nomination is also possible. The Danish Medicines Agency nominates four members to the Danish Pharmacopoeia Commission. These members are at the same time nominated as chairs of the subcommittees. The nomination of members is based on the person’s professional background and experience with medicines development and production. The members are nominated based on their personal competencies and relevant experience. The Ministry of Health appoints a chair and a vice-chair to the Danish Pharmacopoeia Commission.

Members of the Danish Pharmacopoeia Commission are remunerated in accordance with Danish Government regulations. Members of the subcommittees are not remunerated.

The chair presides at the meetings, which are usually held at the Danish Medicines Agency. The vice-chair of the Danish Pharmacopoeia Commission acts as chair if the chair is absent for a long period of time. The National Pharmacopoeia Authority under the Danish Medicines Agency provides secretarial support for the meetings. The commission and subcommittee members should as far as possible inform the secretariat if they are unable to attend a meeting.

Submission of member nominations

Neither the Danish Pharmacopoeia Commission nor its subcommittees are recruiting members at present.
Proposals for the appointment of members can be submitted by email to the National Pharmacopoeia Authority of the Danish Medicines Agency on Send an email.The application must be accompanied by a CV that clearly states the professional competencies and practical experience relevant for the subcommittee applied for.

Conflicting interests

A member of the Danish Pharmacopoeia Commission or a subcommittee is not allowed to participate in discussions of a topic if the member has a personal interest in the matter or any other circumstances could question the member’s impartiality. A member must inform the commission or subcommittee of any potentially conflicting interests before the discussion of a topic begins.

Confidentiality

The members of the Danish Pharmacopoeia Commission and subcommittees are bound by professional secrecy regarding any confidential information that comes to their knowledge as members.

It is the responsibility of the individual member to ensure that the material the member receives as part of serving on the commission or a subcommittee is not disclosed to any third party.

Rules of procedure of the Danish Pharmacopoeia Commission

The legal basis of the Danish Pharmacopoeia Commission is described in Part 13 of the Danish Medicines Act and the executive order on the rules of procedure of the Danish Pharmacopoeia Commission.

Executive Order no. 99 of 16 January 2018 on the Danish Medicines Act (Danish title: ‘Bekendtgørelse nr. 99 af 16. januar 2018 af lov om lægemidler’.

Executive order no. 1234 of 12 December 2005 on the rules of procedure of the Danish Pharmacopoeia Commission (Danish title: 'Bekendtgørelse nr. 1234 af 12. december 2005 om forretningsorden for Farmakopénævnet')

Members of the Danish Pharmacopoeia Commission and subcommittees

Danish Pharmacopoeia Commission

Chair: Anna Arnecke, Ph.D.

Vice-chair: Christian G. Houghton, Sc. Vice President, Cand. Scient.

Poul Bertelsen, Principal Scientist, Ph.D.

Robert Klasson, Regulatory Affairs Specialist, Cand. Scient.

 

Biology Subcommittee

Chair: Christian G. Houghton, Sc. Vice President, Cand. Scient.

Annette Ekblond, Head of Laboratory, Ph.D.

Berit E. B. Hansen, Reference material coordinator, Cand. Scient.

Ellen Sloth Wilhelmsen, Principal Scientist, M. Sc. Engineering

Hanne Mørck Nielsen, Professor, Ph.D.

Nina Pringler, Senior Research Scientist, Cand. Scient.

Ole Schelde, Specialist, M. Sc. In Chemistry and Biology

Sten Erik Jensen, Senior specialist, Ph.D.

 

Pharmacy Subcommittee:

Chair: Poul Bertelsen, Principal Scientist, Ph.D.

Anette Müllertz, Professor, Ph.D.

Annette Bauer-Brandl, Professor, Dr. Pharm.

Hanne Mørck Nielsen, Professor, Ph.D.

Jukka Rantanen, Professor, Ph.D.

Lene Jørgensen, Lektor, Ph.D, Cand. Pharm.

Sven Frøkjær, Professor, Ph.D.

 

Pharmacognosy Subcommittee

Chair: Anna Arnecke, Ph.D.

Bjarne Alstrøm, RA and QA Specialist, Cand. Pharm.

Jens Soelberg, Curator and Lecturer, Ph.D.

Kenneth Thermann Kongstad, Tenure Track Assistant Professor, Ph.D.

Xavier Fretté, Professor, Ph.D.

 

Chemistry Subcommittee:

Chair: Robert Klasson, Regulatory Affairs Specialist, Cand. Scient.

Bente Gammelgaard, Professor, Ph.D. (Pharm)

Gitte Petersen, QC Laboratory Manager, Cand. Pharm.

Conny Svensson, Quality Specialist, Cand. Pharm.

Jakob Mossing, Senior Research Scientist, Cand. Scient.

Jesper Larsen, Lead Specialist, Ph.D.

 

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