Tasks of the Danish Pharmacopoeia Commission
The Danish Health and Medicines Authority consults the Danish Pharmacopoeia Commission in questions concerning requirements for the technical quality of medicinal products.
More specifically, this means whether the medicine is manufactured in the right way, by precursors that contain the right active pharmaceutical ingredient in the required quantity and with insurance that the (inevitable) impurities are only present in a known and very low quantity.
The Commission offers its advice in connection with the preparation of guidelines for the quality of medicines in the EU, in the harmonisation collaboration (the ICH collaboration) between the EU, the USA and Japan and in connection with the work on the European Pharmacopoeia, which applies in Denmark.
he pharmacopoeia is a statute book which contains detailed descriptions of and requirements for all substances (both active pharmaceutical ingredients and excipients) that are used in medicine.
Moreover, the Danish Pharmacopoeia Commission generally cooperates with the Danish Health and Medicines Authority on standardisation and the development hereof. The members also share their knowledge with the Danish Health and Medicines Authority's employees.
The European Pharmacopoeia enters into force as a legislative basis in Denmark in the form of the executive order Danish Drug Standards, which is published three times a year. It takes place synchronously with the entry into force of the supplementary volume to the European Pharmacopoeia. This takes place after a recommendation from the Danish Pharmacopoeia Commission.
Sub-committees under the Danish Pharmacopoeia Commission
Under the Pharmacopoeia Commission, three sub-committees have been set up to support the Danish Health and Medicines Authority's work related to the pharmacopoeia:
- The Pharmacy Sub-Committee, which focuses on the manufacture of completed medicinal products based on pure active pharmaceutical ingredients (APIs) and excipients.
- The Chemistry Sub-Committee, which works on methodology development concerning substances manufactured by chemical synthesis or processing of naturally occurring substances.
- The Pharmacognosy Sub-Committee, which assesses plant medicines.
Within these three fields, the sub-committees give advice on quality requirements for medicine and the raw materials used in the production of medicine.
In principle, the sub-committees can deal with any topic, but it cannot make any decisions.
Each of the three sub-committees under the Danish Pharmacopoeia Commission meet with representatives from the Danish Health and Medicines Authority four times a year.
Members
The Danish Pharmacopoeia Commission consists of no more than 6 members.
Members of the Danish Pharmacopoeia Commission
- Chairman, Professor, Doctor of Pharmacy Steen Honoré Hansen
- Vice-Chairman, Vice President, PhD Birgitte Møllgaard
- Dean, Professor, PhD Sven Frøkjær
- Professor Annette Baur-Brandl
- Senior Scientist, Adjunct Professor, Doctor of Pharmacy Vagn Handlos
- Professor Jukka Rantanen.
Members of the Pharmacy Sub-Committee
- Chairman, Vice President, Chemical & Pharmaceutical Research, PhD Birgitte Møllgaard
- Dean, Professor, PhD Sven Frøkjær
- Senior Scientist, Adjunct Professor, Doctor of Pharmacy Vagn Handlos
- Systems Manager, MSc in Pharmacy Bente Rose Johansen
- Associate Principal Scientist, PhD Poul Bertelsen.
Members of the Chemistry Sub-Committee
- Chairman, Professor, Doctor of Pharmacy Steen Honoré Hansen
- Divisional Director Hans Otto Hansen
- Divisional Director, Licentiate in Pharmacy Elin Jensen
- Senior Director, MSc in Pharmacy Klaus Jensen
- Project Manager, MSc in Pharmacy Gitte Petersen
- QA Manager, MSc in Pharmacy Bent Schøller
- Associate Professor Bente Steffansen
- Professor Bente Gammelgaard.
Members of the Pharmacognosy Sub-Committee
- Chairman, Professor, Doctor of Pharmacy Steen Honoré Hansen
- Consultant, MSc in Pharmacy Bjarne Alstrøm
Term of commission members
The commission members are appointed for four year terms.
Number of meetings
The Commission convenes for at least two annual meetings:
- a meeting between the Danish Pharmacopoeia Commission and the Danish Health and Medicines Authority where the latter's management participates.
- a meeting between the Danish Pharmacopoeia Commission and the Danish Health and Medicines Authority where the Danish experts from EDQM's group of experts participate.
The meetings are usually held at the Danish Health and Medicines Authority.
The Chairman can decide to hold extraordinary meetings, if necessary.
Rationale behind the Commission's composition of professional groups/interests
It is important that the Commission includes representatives from the widest area possible. The members must have detailed knowledge of development and technical quality and control of precursors and medicine.
Even if the members are often affiliated with e.g. universities and the industry, the Danish Health and Medicines Authority emphasises the members' personal expertise and not their place of work.
Appointment of members
The Danish Health and Medicines Authority invites interested parties to nominate members to the Danish Pharmacopoeia Commission.
Anyone can nominate members to the Danish Pharmacopoeia Commission. Self-nomination is also possible.
The Minister for Health and Prevention appoints members after they have been nominated by the Danish Health and Medicines Authority. Apart from suggestions from individuals, the Association of Danish Pharmacies, Pharmadanmark, the Danish Association of Pharmaconomists, etc. can suggest members.
The Minister also appoints a Chairman and a Vice-Chairman among the Commission members – independently of the Danish Health and Medicines Authority's nomination.
Requirements for commission members
The commission members must have an in-depth knowledge and practical experience with manufacture and/or control of active substances and preparations.
Conflicts of interest
A commission member must not participate in the discussion of a topic if he or she has a personal interest in the topic, or if there are any other circumstances which could question his or her impartiality.
Members must inform the Commission of any potentially conflicting interests before the discussion of a topic begins. The Commission decides whether the member may participate in the discussion. The Commission's decision must be recorded in the minutes.
Confidentiality
The commission members are bound by professional secrecy regarding the confidential information they gain knowledge of as members of the Commission.
It is the responsibility of each individual member to ensure that the material the member receives as part of serving on the Commission is not disclosed to any third parties. When a member resigns from the Commission, the member concerned must return all confidential material received while serving on the Commission.
Secretariat of the Danish Pharmacopoeia Commission
The Danish Health and Medicines Authority provides a secretariat for the work of the Commission. The Danish Health and Medicines Authority's CEO decides the extent to which the secretariat may assist the Committee.
Meeting procedure
The Chairman and the secretariat are responsible for the preparatory work of presenting cases to the Commission.
The Chairman summons the committee meetings in writing with at least eight days notice if possible. The secretariat may also summon meetings if the Chairman authorises it to do so.
Notices of meetings must include an agenda. Moreover, the members must, if possible, be sent any documents regarding individual items on the agenda.
The Chairman sets the agenda. For ordinary meetings, the agenda must at least include the following items:
- Approval of minutes from the previous meeting
- Chairman's report
- Secretariat's report
- Any other business.
The Chairman presides over the meetings.
Minutes
Draft minutes are sent out in Danish as soon as possible and at the latest when the next ordinary meeting is summoned.
Any objections to the minutes must be submitted no later than at the next ordinary commission meeting. However, the Chairman and secretariat must be informed immediately if objections are made to the way in which the content of a discussion is presented. Subsequently, the minutes are published in Danish on the Danish Health and Medicines Authority's website.
Decision-making process
The Danish Pharmacopoeia Commission does not make any decisions, but it makes recommendations to the Danish Health and Medicines Authority based on the Commission's discussions.
Participants at the commission meetings
The Pharmacopoeia Commission's meetings are not public. The Commission may only hold meetings with third parties if it has been agreed with the Danish Health and Medicines Authority in advance.
Employees from the secretariat and other employees from the Danish Health and Medicines Authority can attend the meetings to the extent the Chairman decides.
Absence
The commission members must to the extent possible inform the secretariat if they are unable to attend a commission meeting.
A meeting is postponed if both the Chairman and the Vice-Chairman are absent.
The Vice-Chairman acts as Chairman if the Chairman is absent for a long period of time.
Transparency of the Commission's work
Minutes of the meetings of the Danish Pharmacopoeia Commission are published here at the Danish Health and Medicines Authority's website.
Minutes must be taken at each committee meeting. The minutes must at least include information about:
- where and when the meeting was held.
- names of meeting attendants, including the name of the minute-taker.
- agenda of the meeting.
- time and place of the next ordinary meeting.
Remuneration
Commission members are remunerated in accordance with Danish Government regulations.
