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Pharmacopoeia Commissions
The AMG § 55 specifies that the German, European and Homeopathic Pharmacopoeia Commission are the highest decision-making boards for the Pharmacopoeia.
The Commissions have equal rights and decide autonomously in their respective areas of responsibility.
Since European rules supersede national rules and the secretariat of the Office of the Pharmacopoeia Commissions coordinates the work of the German and Homeopathic Pharmacopoeia Commission, there is no overlap.
German Pharmacopoeia Commission
For the German Pharmacopoeia Commission the AMG states in § 55 Abs. 4: "The German Pharmacopoeia Commission is established at the Federal Institute for Drugs and Medical Devices. The Federal Institute for Drugs and Medical Devices appoints the members of the German Pharmacopoeia Commission from experts in medical and pharmaceutical science, the health care professions, the pharmaceutical business associations involved and drug inspection authorities in equal numbers, chairs the Commission and issues rules of procedure. All this is done in common agreement with the Paul Ehrlich Institute and the Federal Office for Consumer Protection and Food Safety. The rules of procedure of the Commissions require the approval of the Federal Ministry in consultation with the Federal Ministry of Food and Agriculture. The members are bound to confidence.
The Rules of Procedure of the German Pharmacopoeia Commission provide that the members of the Commission are appointed for a period of five years (§ 2 Abs. 1) and that the Commission appoints expert committees (§ 7). The Chairs for the expert committees are elected by the Commission from among their members or deputy members on the proposal of the Chair of the Commission (§ 7 Abs. 2). The expert committees may form working parties for specific issues in agreement with the Chair of the Commission (§ 8).
The European Pharmacopoeia Commission adopted the following texts at its 178th meeting in March 2024.
NEW TEXTS
GENERAL CHAPTERS
2.5.44. Capillary isoelectric focusing for recombinant therapeutic monoclonal antibodies
5.1.13. Pyrogenicity
MONOGRAPHS
Dosage forms
Orodispersible films (3195)
Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations
Defluorotrimethylaminium-PSMA-1007 for radiopharmaceutical preparations (3158)*
Edotreotide acetate for radiopharmaceutical preparations (2544)*
Gozetotide for radiopharmaceutical preparations (3042)*
Oxodotreotide acetate for radiopharmaceutical preparations (3157)*
Herbal drugs and herbal drug preparations
White mulberry leaf (3164)
Homoeopathic preparations
Iberis amara for homoeopathic preparations (2838)
Monographs
Dapagliflozin propylene glycol monohydrate (3137)
Dapagliflozin propylene glycol tablets (3175)
Memantine hydrochloride (2773)
Olodaterol hydrochloride (3174)
Rosuvastatin zinc tetrahydrate (3135)
REVISED TEXTS
GENERAL CHAPTERS
2.4.20. Determination of elemental impurities
2.6.30. Monocyte-activation test
2.6.40. Monocyte-activation test for vaccines containing inherently pyrogenic components
2.7.24. Flow cytometry
3.1.3. Polyolefins
3.1.4. Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparations
3.1.5. Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations
3.1.6. Polypropylene for containers and closures for parenteral preparations and ophthalmic preparations
3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing for total parenteral nutrition preparations
3.3.4. Sterile plastic containers for human blood and blood components
3.3.7. Sets for the transfusion of blood and blood components
5.1.10. Guidelines for using the test for bacterial endotoxins
5.2.6. Evaluation of safety of veterinary vaccines and immunosera
5.2.7. Evaluation of efficacy of veterinary vaccines and immunosera
5.2.11. Carrier proteins for the production of conjugated polysaccharide vaccines for human use
5.22. Names of herbal drugs used in traditional Chinese medicine
5.31. Phage therapy medicinal products
5.34. Additional information on gene therapy medicinal products for human use
MONOGRAPHS
General monographs
Immunosera for human use, animal (0084)
Pharmaceutical preparations (2619)
Radiopharmaceutical preparations (0125)
Substances for pharmaceutical use (2034)
Vaccines for human use (0153)
Vaccines for veterinary use (0062)
Dosage forms
Intravesical preparations (2811)
Oromucosal preparations (1807)
Parenteral preparations (0520)
Preparations for irrigation (1116)
Vaccines for human use
Diphtheria, tetanus, pertussis (acellular, component) and haemophilus type b conjugate vaccine (adsorbed) (1932)
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) (2067)
Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) (2065)
Haemophilus type b and meningococcal group C conjugate vaccine (2622)
Haemophilus type b conjugate vaccine (1219)
Hepatitis B vaccine (rDNA) (1056)
Meningococcal group A, C, W135 and Y conjugate vaccine (3066)
Meningococcal group C conjugate vaccine (2112)
Meningococcal polysaccharide vaccine (0250)
Pneumococcal polysaccharide conjugate vaccine (adsorbed) (2150)
Pneumococcal polysaccharide vaccine (0966)
Rabies vaccine for human use prepared in cell cultures (0216)
Tick-borne encephalitis vaccine (inactivated) (1375)
Vaccines for veterinary use
Salmonella Enteritidis vaccine (live, oral) for chickens (2520)
Salmonella Typhimurium vaccine (live, oral) for chickens (2521)
Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations
Gallium (68Ga) chloride solution for radiolabelling (2464)
Technetium (99mTc) human albumin injection (0640)
Tetra-O-acetyl-mannose triflate for radiopharmaceutical preparations (2294)
Herbal drugs and herbal drug preparations
Ash leaf (1600)
Black horehound (1858)
Burdock root (2943)
Horse-chestnut bark (2945)
Moutan bark (2474)
Narrow-leaved coneflower root (1821)
Pale coneflower root (1822)
Pumpkin seed (2941)
Purple coneflower herb (1823)
Purple coneflower root (1824)
Ribwort plantain (1884)
Rosemary leaf (1560)
Homoeopathic preparations
Cuprum aceticum for homoeopathic preparations (2146)
Monographs
Amikacin sulfate (1290)
Anticoagulant and preservative solutions for human blood (0209)
Anti-T lymphocyte immunoglobulin for human use, animal (1928)
Atropine sulfate (0068)
Bovine serum (2262)
Calcium levulinate dihydrate (1296)
Chloramphenicol sodium succinate (0709)
Chlorhexidine digluconate solution (0658)
Colistimethate sodium (0319)
3-O-Desacyl-4’-monophosphoryl lipid A (2537)
Dicloxacillin sodium (0663)
Doxapram hydrochloride (1201)
Flucloxacillin sodium monohydrate (0668)
Flumetasone pivalate (1327)
Glucose (0177)
Glucose monohydrate (0178)
Haemodialysis, solutions for (0128)
Haemofiltration and haemodiafiltration, solutions for (0861)
Human albumin solution (0255)
Human alpha-1-proteinase inhibitor (2387)
Human antithrombin III concentrate (0878)
Human C1-esterase inhibitor (2818)
Human coagulation factor VII (1224)
Human coagulation factor VIII (0275)
Human coagulation factor IX (1223)
Human coagulation factor XI (1644)
Human fibrinogen (0024)
Human normal immunoglobulin for intramuscular administration (0338)
Human normal immunoglobulin for intravenous administration (0918)
Human normal immunoglobulin for subcutaneous administration (2788)
Human plasma (pooled and treated for virus inactivation) (1646)
Human prothrombin complex (0554)
Human von Willebrand factor (2298)
Kanamycin acid sulfate (0033)
Kanamycin monosulfate (0032)
Methylene chloride (0932)
Peritoneal dialysis, solutions for (0862)
Polymyxin B sulfate (0203)
Procainamide hydrochloride (0567)
Propylthiouracil (0525)
Simeticone (1470)
Sodium citrate (0412)
Sodium molybdate dihydrate (1565)
Solutions for organ preservation (1264)
Sorafenib tosilate (2931)
Thiamazole (1706)
The European Pharmacopoeia Commission is based on the Convention for the Elaboration of a European Pharmacopoeia and is composed of the delegations representing the contracting parties to the Convention, currently 39 member states and the European Union (EU). . Up to three members of a delegation are appointed by the Contracting Party based on their experience and competence. The head of the German delegation to the European Pharmacopoeia Commission is an employee of the Federal Institute for Drugs and Medical Devices.
The European Pharmacopoeia Commission elects a Chair and two Vice-Chairs for a period of three years. The current Chair is Prof. Dr. Salvador Canigueral (Spain).
The Commission appoints the expert committees and working parties. Comments and statements intended for the European Pharmacopoeia Commission should be addressed to the Secretary of the office of the German Pharmacopoeia Commission (arzneibuch@bfarm.de or Yvonne.urbach@bfarm.de). This is necessary because the European Pharmacopoeia Commission expects to receive consolidated national statements and only consolidated national statements will usually be transferred to its expert committees and working parties. Statements that are not submitted by the competent pharmacopoeia authorities or delegations may go unprocessed.
The Homeopathic Pharmacopoeia Commission is appointed by the Federal Institute for Drugs and Medical Devices in agreement with the Paul Ehrlich Institute and the Federal Office for Consumer Protection and Food Safety according to the same rules (§ 55 Abs. 6 AMG) just as the German Pharmacopoeia Commission. The current rules of procedure of the Commission are published according to § 77a AMG.
The rules of procedure of the German and the Homeopathic Pharmacopoeia Commission specify that the Office of the Commissions, its expert committees and their working parties are established at the Federal Institute for Drugs and Medical Devices.
The Office of the Pharmacopoeia Commissions organizes the meetings of the German and Homeopathic Pharmacopoeia Commissions as well as those of their expert committees and working parties. It receives, processes and, where necessary, replies to all consignments intended for the committees.
This includes assignment to certain committees or working parties and supplementation by own scientific work carried out in-house or by external experts on behalf of the secretariat. As soon as the committees have conclusively discussed monographs or other texts, they are published in the Federal Gazette (“Bundesanzeiger”) by the secretariat in order to give interested parties the opportunity to comment.
After the commenting period, the texts are presented to the concerned Pharmacopoeia Commission for decision, if necessary after further consultation within the committees. The Office of the Pharmacopoeia Commissions is also the contact for comments on the European Pharmacopoeia.
The Office of the Pharmacopoeia Commissions can be contact at the following address:
Federal Institute for Drugs and Medical Devices
Office of the Pharmacopoeia Commissions
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Secretariat of the European Pharmacopoeia Commissions
The Secretariat of the European Pharmacopoeia Commission is part of the European Directorate for the Quality of Medicines & HealthCare (EDQM), which is located at the Council of Europe in Strasbourg. Director of the EDQM is Dr. Petra Doerr. The secretariat, headed by Mrs. Cathie Vielle, organizes the meetings of the European Pharmacopoeia Commission and its expert committees and working parties. The secretariat receives, processes and replies to all items destined for the committees as far as necessary. This includes the assignment to certain expert committees or working parties and the supplementation by own scientific work carried out by the EDQM, the experts of the groups or companies concerned. As soon as monographs or other texts have been conclusively discussed by the expert groups, they are published by the EDQM in the journal Pharmeuropa in order to give interested parties the opportunity to comment before the texts are adopted by the European Pharmacopoeia Commission. Finally, the texts are submitted to the Commission for decision, if necessary after further discussion in the expert committees.
Comments on texts published in Pharmeuropa should be addressed to the national pharmacopoeia authorities. The same applies to all other comments on the European Pharmacopoeia. The responsible body in Germany is the Office of the Pharmacopoeia Commissions.
Adresses
The address of the director of the EDQM is:
Director
European Directorate for the Quality of Medicines & HealthCare
Council of Europe
7 allée Kastner
CS 30026
F 67081 STRASBOURG (France)
Phone (0033) 3 88 41 28 83
The address of the Secretariat of the European Pharmacopoeia Commission is:
Secretariat of the European Pharmacopoeia Commission
Council of Europe
7 allée Kastner
CS 30026
F 67029 STRASBOURG (France)
Fax: (0033) 3 88 41 27 71
website: www.edqm.eu
The office of the European Pharmacopoeia Commission is currently represented by:
Chemically Defined Substances, Finished Products, General Chapters and Herbal Division (Division A)
Dr. Ulrich Rose
Phone +33-39021-4518
Email: Ulrich.rose@edqm.eu
Biologicals and Others Division (Division B)
Dr. Emmanuelle Charton
Phone +33-38841-3640
Email: emmanuelle.charton@edqm.eu
Pharmeuropa
Pharmeuropa is a quarterly journal of the EDQM and serves primarily for the communication between the European Pharmacopoeia Commission, its expert committees and working parties and its secretariat with those interested in the European Pharmacopoeia. The main content are therefore texts that are published to give interested parties (stakeholders) the opportunity to comment. These texts are usually supplemented by information about used instruments or materials, reagents, columns for chromatography, etc., which cannot be mentioned in the European Pharmacopoeia because they are usually trademarks. Often, the published texts are supported by explanations, which will not be included in the European Pharmacopoeia either.
The EDQM uses Pharmeuropa also, to conduct surveys among interested parties, for example to determine the value of a planned monograph or to contact suppliers of a substance. In addition, special issues of the journal Pharmeuropa (Scientific Notes) regularly publish scientific articles of interest to the pharmacopoeia.
In addition to the regular issues of Pharmeuropa, special announcements of the EDQM are published on the website that are dedicated to specific topics. These include reports on congresses organized by the EDQM, list of Standard Terms or updated versions of the Technical Guides for the Elaboration of Monographs.
Information on Pharmeuropa are available on the EDQM website: www.edqm.eu
Certificate of conformity – CEP Procedure
The procedure for issuing a certificate of conformity by the EDQM has been published as Resolution AP/CSP (99) 4 of the Public Health Committee of the Council of Europe. The certificate of conformity is issued at the request of a manufacturer or his authorized representative after a dossier submitted by them has been examined and accepted by experts.
Information on the certificate of conformity is available under the keyword "Certification" on the EDQM website. www.edqm.eu
The certificate of conformity consists of three forms:
- Certification of conformity (better: certification of the suitability of a monograph to test a substance from a specific source) with the monograph of an active substance or excipients.
- Certification of conformity with the monograph "Products presenting a risk of transmitting animal spongiform encephalopathy agents".
- Certification of conformity for herbal products used in the production or preparation of pharmaceutical products.
The certificate of conformity with the monograph of a substance is to demonstrate that a monograph of the European Pharmacopoeia is appropriate to adequately control the quality of a substance from a given source. In particular, it shall demonstrate that the monograph is capable of controlling the impurities that the substance may contain when it is derived from that source. However, the certificate of conformity shall in no way guarantee that the individual batches of the substance are of sufficient quality. It does not therefore replace the test according to the monograph.
The certificate of conformity with the monograph "Products presenting a risk of transmitting animal spongiform encephalopathy agents" proves that the manufacturer of the product uses starting materials from a specific country of origin, specific organs and, in some cases, a specific manufacturing process. A further condition for the issue of the certificate is that the manufacturer provides evidence that the product is produced under an appropriate quality management system. The certificate is a basis for the assessment of the safety of medicinal products by the competent authorities, for example in the marketing authorisation procedure. However, the certificate cannot replace this evaluation.
Requests for the certificate of conformity or applications for a certificate of conformity can be addressed to the EDQM.
Ms. Hélène Bruguera
European Directorate for the Quality of Medicines Council of Europe
B.P. 907
F 67029 STRASBOURG CEDEX 1
Telephone +33-390 214218
Email: cep@edqm.eu
Standard Terms
Standard Terms are certain terms intended to describe the pharmaceutical forms, route of administration and special containers of medicinal products. A list of these terms, published on the EDQM website, was compiled at request of the European Commission by a working party of the European Pharmacopoeia Commission. The list is continuously compiled.. The terms mentioned in the list are used in the marketing authorisation procedure (and the competent authorities may require these terms to be used in national the marketing authorisation procedure. This list also serves to facilitate the translation of the terms from one European language into another.
More information and explanations on the Standard Terms and their addition to the list are available on the EDQM website: http://www.edqm.eu
Technical Guide for the Elaboration of Monographs
Der Technical Guide for the Elaboration of Monographs (Technical Guide) beschreibt den Aufbau von und die technischen Anforderungen an Monographien des Europäischen Arzneibuchs. Der Technical Guide behandelt vorerst hauptsächlich Monographien zu chemisch definierten Substanzen. Doch sind Technical Guides für andere Substanzen in Arbeit. Der Technical Guide für Monographien zu chemisch definierten Substanzen wurde vom EDQM als Sonderheft von Pharmeuropa publiziert.
Der Technical Guide ist in erster Linie als Grundlage für die Erarbeitung von Monographien für das Europäische Arzneibuch gedacht. Es ist jedoch erwünscht, dass auch nationale Monographien nach den Regeln des Technical Guides erarbeitet werden, damit sich diese später gegebenenfalls leichter in Monographien des Europäischen Arzneibuchs überführen lassen. Der Technical Guide kann ferner als Richtschnur für alle anderen Monographien dienen, beispielsweise für solche, die im Zulassungsverfahren vorzulegen sind.
Informationen zum Technical Guide als Sonderausgabe von Pharmeuropa erhalten Sie auf der Website des EDQM.
Pharmeuropa drafts / HAB- and DAB-Drafts
Your statement or comment is welcome!
The Office of the German Pharmacopoeia Commissions accepts comments on the German, European or Homeopathic Pharmacopoeia. In addition, new or revised monographs and methods are published in the Federal Gazette (Bundesanzeiger) or Pharmeuropa, to give all interested parties the opportunity to comment. In the following you can find out which texts have been published for comment and what deadlines apply for the submission of a statement.
European Pharmacopoeia - draft Monographs
The European Pharmacopoeia has various procedures for preparing a monograph or a general method. For each procedure, the last step is a publication of a draft in the journal "Pharmeuropa". Below you can find the link to "Pharmeuropa online" where you can register under "login" and a "current table of contents of Pharmeuropa". Comments can be submitted within 3 months (in justified cases an extension of this deadline may be requested) and they will be discussed in the relevant expert committee of the German Pharmacopoeia Commission.
Please send your comments in writing, if possible for Pharmeuropa comments in English, to:
Federal Institute for Drugs and Medical Devices
- Office of the Pharmacopoeia Commissions -
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Dr. Yvonne Urbach
Preferably by e-mail to: yvonne.urbach@bfarm.de or Arzneibuch@bfarm.de
Homeopathic Pharmacopoeia
The rules of procedure of the Homeopathic Pharmacopoeia Commission provide in § 3 Abs. 5 for a hearing of the state health and veterinary authorities as well as the concerned professional and pharmaceutical associations before a monograph can be adopted by the Commission. This hearing is carried out by publication in the Federal Gazette. In addition, certain pharmaceutical journals shall reproduce this publication in unabridged form. Comments can be submitted during a 3 month commenting period to the Office of the German Pharmacopoeia Commissions (in justified cases an extension of this deadline may be requested) and will be discussed in the relevant expert committee of the Homeopathic Pharmacopoeia Commission .
Please send your comments in writing to:
Federal Institute for Drugs and Medical Devices
- Office of the Pharmacopoeia Commissions -
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Dr. Yvonne Urbach
Preferably by e-mail to: yvonne.urbach@bfarm.de or Arzneibuch@bfarm.de
German Pharmacopoeia
The rules of procedure of the German Pharmacopoeia Commission provide in § 3 Abs. 5 for a hearing of the state health and state veterinary authorities as well as the affected professional and pharmaceutical associations before a monograph can be adopted by the German Pharmacopoeia Commission. Comments can be submitted during a 3 month commenting period to the Office of the German Pharmacopoeia Commissions (in justified cases an extension of this deadline may be requested) and will be discussed in the relevant expert committee.Currently, no draft monographs or draft methods are available for consultation.
Request for Revision of a monograph or method
(Requests)
The European Pharmacopoeia is a compendium of several thousand texts that are reviewed with a time delay for revision. Therefore, it may occur that, for example due to technical progress, a need for revision arises. In addition, the original texts of the European Pharmacopoeia are published in English and French and then translated into German. With regard to the German translation, the need for revision may also arise. We kindly ask you to send your requests for revision using the form linked below, if necessary use an attachment. Your requests for revision will be discussed in the relevant expert committees of the German Pharmacopoeia Commission, and, an official German request for revision may be submitted to the European Pharmacopoeia Commission. This formcan also be used for requests changes to the German and Homeopathic Pharmacopoeia.
