Ph. Eur. Pharmacopoeia Europaea (European Pharmacopoeia)
Ph. Helv. Pharmacopoeia Helvetica (Swiss Pharmacopoeia)
Last updated on: 07.12.2012
Abbreviations: What are the usual abbreviations for the Pharmacopoeia?
Book: Additions to the Ph. Eur.: Supplements to the Ph. Eur.: When a supplement is published, can I dispose of the previous editions?
No, the supplements are not cumulative. They thus constitute the basic Pharmacopoeia and all the supplements are valid until a new basic work is published.
Last updated on: 07.12.2012
Book: Combination of the Ph. Eur. and Ph. Helv.?: Why is it not possible for the two Pharmacopoeias to be published together in a single work?
The co-ordination resources involved would be disproportionately high, because several publishers handle the Ph. Eur. In addition, the updates to the Ph. Eur. and Ph. Helv. take place at different intervals. The Ph. Eur. Is moreover not published in Italian.
Last updated on: 07.12.2012
Book: German edition of the Ph. Eur.: Why is the German edition of the Ph. Eur. only available after it has come into force? / If it is not available, how can we work with it?
The German translation is carried out in collaboration with Germany and Austria. It is translated from the original published by the Council of Europe.
Until the German edition is available, individual texts can be ordered as galley proofs from the Swissmedic Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).
Information is provided regarding modifications to texts or additions prior to them coming into force (see Swissmedic and EDQM websites).
Further information > www.edqm.eu > European Pharmacopoeia > Work Programme or www.swissmedic.ch > Publications > Swissmedic Journal or www.swissmedic.ch > Pharmacopoeia > Important information
Note: When ordering a large amount of galley proofs, a fee may be charged for the increased processing time (over half an hour). In such cases, you will be notified of the costs involved before your order is processed.
Last updated on: 07.12.2012
Book: Supplements to the Ph. Helv.; Supplements to the Ph. Helv.: When a supplement is published, can I dispose of the previous editions?
Only the previous supplements. The basic work and the latest supplement (cumulative) are valid until a new basic work is published.
Last updated on: 07.12.2012
Costs: Defining the prices: Who defines the prices for the Ph. Eur. and the Ph. Helv.?
For publications in Switzerland, the Federal Office for Buildings and Logistics (BBL) is responsible for defining the price, based on the Publications Act.
Further information > www.bundespublikationen.admin.ch (EDI, Swissmedic)
Last updated on: 01.07.2016
Costs: General: Does the Pharmacopoeia cost anything?
Yes. The Pharmacopoeia, in all its forms, must be purchased in accordance with the Federal Publications Act. It must also be purchased in other countries, so Switzerland is no exception.
Further information > Federal act of 18 June 2004 on the Compendium of Federal Law and the Federal Gazette (Publications Act, PublG; SR 170.512), www.admin.ch/ch/d/sr/170_512/
Last updated on: 07.12.2012
Costs: Online version: Why is the online version not (much) cheaper since there is no need to print a book?
Ph. Eur.
- French and English: the work is published by the Council of Europe, which also establishes the price.
- German: No online version available
Ph. Helv.
- The online version cannot be obtained separately but is a practical, additional service for owners of the book. As specified in the Federal Publications Act, it must be purchased.
Further information > Federal Law of 18 June 2004 on the Compendium of Federal Law and the Federal Gazette (Publications Act, PublG; SR 170.512), www.admin.ch/ch/d/sr/170_512/
Last updated on: 07.12.2012
Costs Ph. Eur.: What does the Ph. Eur.cost?
The publishers must be contacted regarding the current prices (see "Publishers").
Last updated on: 07.12.2012
Costs Ph. Helv.: What does the Ph. Helv. cost?
Contact the Federal Office for Buildings and Logistics (BBL) regarding the price.
Further information > see www.bundespublikationen.admin.ch (EDI, Swissmedic)
Last updated on: 01.07.2016
Costs Pharmeuropa: Does the Pharmeuropa cost anything?
No. Since 1 January 2012, the Pharmeuropa is only available as an online version, and is free of charge (previously only for purchase, in the print version).
Further information > pharmeuropa.edqm.eu/home/
Last updated on: 01.07.2016
Elaborating of the Pharmacopoeia: Ph. Eur.: Who is involved in the elaboration of the Ph. Eur.?
- EDQM, European Directorate for the Quality of Medicines and HealthCare (European Pharmacopoeia Organisation): provides the scientific secretariats, laboratories and administration for the Ph. Eur.
- EPC, European Pharmacopoeia Commission: Takes decisions on the work programme of the Ph. Eur. and adopts the texts of the Ph. Eur. Consists of delegations of the 37 Member States plus the EU as an organisation. In addition, 27 observer states and the WHO take part in sessions of the EPC.
- Expert and Working Groups of the Ph. Eur.: The content of
the monographs and other texts of the Pharmacopoeia is elaborated in around 20 Expert Groups and over 40 Working Groups, and tested in the laboratory. The experts in these groups come from the 37 European States that have signed the Convention on the elaboration of a European Pharmacopoeia. - CD-P-PH, Experts Steering Committee on Pharmaceuticals and Pharmaceutical Care of the EDQM: Establishes the date of entry into force of the approved monographs by means of a resolution.
Further information > www.swissmedic.ch > Pharmacopoeia > Document "The Pharmacopoeia"
Last updated on: 01.07.2016
Elaborating of the Pharmacopoeia: Ph. Helv.: Who is involved in elaborating of the Ph. Helv.?
- The Swiss Pharmacopoeia Commission (SPK): Advises Swissmedic with regard to the elaboration of the Ph. Helv. and approves the texts of the Ph. Helv.
- Expert committees: Biological products, chemistry, galenic forms, complementary medicinal products and phytochemistry. An expert committee exists for each of these fields, appointed by the Director of Swissmedic and consisting of 10-15 experts that bring in considerable external expertise and practical experience. The scientific secretariat of the expert committees is handled by a staff member from the Pharmacopoeia division.
- Ad-hoc working groups: Ad-hoc working groups are set up for specific topics, such as for GMP small quantities.
Further information > www.swissmedic.ch > Pharmacopoeia > Document "The Pharmacopoeia"
Last updated on: 07.12.2012
Enquiries: Is a fee charged for my enquiries to the Pharmacopoeia division?
Normally, no. In rare cases, i.e. when there is considerable processing time involved (more than half an hour), fees may be applied. In such cases, you will be notified of the costs involved before your enquiry is processed.
Last updated on: 07.12.2012
Entry into force: Who is responsible for enacting the Pharmacopoeia in Switzerland?
The Agency Council is responsible for the entry into force of the Ph. Eur. and
Ph. Helv. by means of an Agency Ordinance. A new supplement to the Ph. Eur. enters into force three times per year, on 1 January, 1 April and 1 July. The Agency Council is bound by State contract to the said dates for entry into force. The Ph. Helv. and its supplements normally enter into force, in the three official languages, once per year; the Agency Ordinance is therefore modified and re-enacted three times per year.
Further information > www.swissmedic.ch > Pharmacopoeia > Legislation > Verordnung des Schweizerischen Heilmittelinstituts vom 9. November 2001 über den Erlass der Pharmakopöe und die Anerkennung von Arzneibüchern (SR 812.214.11)
Last updated on: 07.12.2012
Entry into force: Dates: Where do I find the dates for entry into force?
The currently valid date for the entry into force can be found on the Swissmedic website.
Further information > www.swissmedic.ch > Pharmacopoeia > Implementation dates
Last updated on: 07.12.2012
Errors: What should I do if I find an error in the Pharmacopoeia?
Ph. Eur.
- English & French: Please contact the help desk on the EDQM website (http://www.edqm.eu/).
- German: Please contact the Swissmedic Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).
Ph. Helv.
Please contact the Swissmedic Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).
Last updated on: 07.12.2012
Galley proofs: Can I obtain German texts before the German edition of the Ph. Eur. is published?
Yes. Individual texts can be ordered as galley proofs from the Swissmedic Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).
Note: When ordering a large amount of galley proofs, a fee may be charged for the increased processing time (over half an hour). In such cases, you will be notified of the costs involved before your order is processed.
Last updated on: 07.12.2012
Languages: Ph. Eur.: In which languages is the Ph. Eur. available?
See "Forms of publication"
Last updated on: 07.12.2012
Languages: Ph. Helv.: In which languages is the Ph. Helv. available?
See "Forms of publication"
Last updated on: 07.12.2012
Languages: Ph. Helv. In English?: Does the Ph. Helv. exist in English?
No. The publication is part of national law and therefore published in the official languages of Switzerland, meaning German, French and Italian.
Last updated on: 07.12.2012
Legal basis: What is the legal basis for the Pharmacopoeia?
- Übereinkommen vom 22. Juli 1964 über die Ausarbeitung einer Europäischen Pharmakopöe (Staatsvertrag; SR 0.812.21)
- Protokoll vom 16. November 1989 zu dem Übereinkommen über die Ausarbeitung einer Europäischen Pharmakopöe (SR 0.812.211)
- Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA, SR 812.21)
- Verordnung vom 17. Oktober 2001 über die Pharmakopöe (Pharmakopöeverordnung, PhaV; SR 812.211)
- Verordnung des Schweizerischen Heilmittelinstituts vom 9. November 2001 über den Erlass der Pharmakopöe und die Anerkennung von Arzneibüchern (SR 812.214.11)
Further information > www.swissmedic.ch > Pharmacopoeia > Legislation
Last updated on: 07.12.2012
Licencing: On how many PCs can the Ph. Helv. be installed?
Access to the Ph. Helv. online is an additional service with the book. The book grants a licence for 5 user accounts, meaning that it can be installed at 5 workplaces.
Last updated on: 07.12.2012
Monograph (elaboration): Ph. Eur.: How is a Ph. Eur. monograph elaborated?
Details of how a Ph. Eur. monograph is elaborated can be found on the EDQM website.
Further information > www.edqm.eu/en/European-Pharmacopoeia-participate-54.html
Last updated on: 01.07.2016
Monograph (elaboration): Ph. Helv.: How is a Ph. Helv. monograph elaborated?
Details of how a Ph. Helv. monograph is elaborated are on the Swissmedic website.
Further information > www.swissmedic.ch > Pharmacopoeia > Elaboration of the Pharmacopoeia
Last updated on: 01.07.2016
Monographs (drafts): Comments on drafts of the Ph. Eur.: How can comments regarding drafts of the Ph. Eur. be submitted?
Contact the Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).
Last updated on: 07.12.2012
National Pharmacopoeia: Why does Switzerland have its own Pharmacopoeia?
Like many European States, Switzerland elaborates its own Pharmacopoeia to complete the Ph. Eur. This permits Switzerland to implement quality provisions rapidly and in a flexible way.
Last updated on: 07.12.2012
Obtaining copies from Swissmedic?: Can I obtain the Pharmacopoeia from Swissmedic?
No. The distribution of Federal publications is centralised via the Federal Office for Buildings and Logistics (BBL).
Further information > www.bundespublikationen.admin.ch (EDI, Swissmedic)
Last updated on: 01.07.2016
Obtaining the: Ph. Eur.: Where can I obtain a copy of the Ph. Eur.?
Book
- German and French: Federal Office for Buildings and Logistics (BBL), Publications Dept., 3003 Bern
- English: EDQM, F-67081 Strasbourg
Data carrier
- USB Stick French and English: EDQM, F-67081 Strasbourg
- DVD German: Federal Office for Buildings and Logistics (BBL), Publications Dept., 3003 Bern
Online version
- French and English: EDQM, F-67081 Strasbourg
- German: no online version available
Further information > www.bundespublikationen.admin.ch (EDI, Swissmedic) or www.edqm.eu/store/
Last updated on: 01.07.2016
Obtaining the Ph. Helv.: Where can I obtain a copy of the Ph. Helv.?
Book, incl. access to the online version
- German, French, Italian: Federal Office for Buildings and Logistics (BBL), Publications Dept.; 3003 Bern
Further information > www.bundespublikationen.admin.ch (EDI, Swissmedic)
Last updated on: 01.07.2016
Pharmacopoeia: the division: Pharmacopoeia – the division. What are its tasks?
The Pharmacopoeia division is the National Pharmacopoeia Authority (NPA) and co-ordinates the network of around 120 Swiss experts who are involved in elaborating the Pharmacopoeia. This corresponds to the basis of involving interested sectors in the elaboration up of the Pharmacopoeia, as stipulated in the Therapeutic Products Act (Art. 52, para. 2).
The main tasks are:
- Collaborating with the elaboration up of the Ph. Eur.
- Drawing up and publishing the Ph. Helv.
- Co-ordinating, on a Swiss and European level, all those involved in the Pharmacopoeia
Further information > www.swissmedic.ch > Pharmacopoeia > Document "the Pharmacopoeia"
Last updated on: 07.12.2012
Pharmacopoeia: the work: Pharmacopoeia – the work. What does that mean?
The Pharmacopoeia is a collection of provisions regarding the quality of active substances, pharmaceutical excipients, pharmaceutical preparations (e.g. forms of administration, vaccines, radiopharmaceutical preparations, preparations from herbal drugs, homeopathic preparations) and other products (e.g. suture materials).
The Ph. Eur. contains over 2,000 single monographs.
The Ph. Helv. contains over 200 monographs and general texts.
These provisions are binding. They are valid for all medicinal products and pharmaceutical excipients on the market in Switzerland.
They are also international: the Ph. Eur. is elaborated under the aegis of the Council of Europe and comes into force simultaneously in the 37 European States that have signed the Convention on the elaboration of a European Pharmacopoeia.
Like many European States, Switzerland elaborates a national Pharmacopoeia (Ph. Helv.) to complete the Ph. Eur. This permits Switzerland to implement quality provisions rapidly and in a flexible way.
Further information > www.swissmedic.ch >Pharmacopoeia >Document "The Pharmacopoeia"
Last updated on: 01.07.2016
Pharmeuropa: What is the Pharmeuropa?
The Pharmeuropa is the publications entity of the EDQM. Among other features, draft monographs from the Expert and Working Groups are published for public consultation.
Further information > Pharmeuropa Online
Last updated on: 01.07.2016
Publication forms: Ph. Eur.: In what form is the Ph. Eur. available?
See "Obtaining a copy of the Ph. Eur."
Last updated on: 07.12.2012
Publication forms: Ph. Helv.: In what form is the Ph. Helv. available?
See "Obtaining a copy of the Ph. Helv."
Last updated on: 07.12.2012
Publication forms: Ph. Helv. as a ring binder?: Why is the Ph. Helv. not available as a ring binder with sheets to add (instead of supplements)?
The Ph. Helv. 7 was the last edition available as a ring binder. After that, the Council of Europe began to issue three updates a year. In addition, a large number of the monographs in the Ph. Helv. were included in the Ph. Eur. The resources necessary for continuing to update the Ph. Helv. would have increased constantly. In addition, a loose-leaf system for a binding (legal) document no longer corresponds to current practices.
Last updated on: 07.12.2012
Publisher: Ph. Eur.: Who publishes the Ph. Eur.?
The Ph. Eur. is published in the original (French and English) by the Council of Europe.
The Ph. Eur. in German is published in collaboration with Germany and Austria.
Further information > www.edqm.eu/store/ or www.bundespublikationen.admin.ch (EDI, Swissmedic)
Last updated on: 01.07.2016
Publisher: Ph. Helv.: Who publishes the Ph. Helv.?
The Ph. Helv. is drafted and published by Swissmedic, the Swiss Agency for Therapeutic Products.
Further information > www.bundespublikationen.admin.ch (EDI, Swissmedic)
Last updated on: 01.07.2016
Support (online version): Where can I get help if I have problems accessing the online version?
Ph. Eur.: Please contact the Help desk via the EDQM website (http://www.edqm.eu/).
Ph. Helv.: Please select the "Help" section at http://www.phhelv.ch/.
Last updated on: 07.12.2012
Validity: What are the elements that constitute the Pharmacopoeia and what are the currently valid editions?
In Switzerland, the Pharmacopoeia consists of the European Pharmacopoeia (Ph. Eur.) and the Swiss Pharmacopoeia (Ph. Helv.). The currently valid editions and their date of entry into force are published on the Swissmedic website.
Further information > www.swissmedic.ch > Pharmacopoeia > Dates of entry into force
Last updated on: 07.12.2012
Working with the entities responsible: Ph. Eur.: Who can I contact if I am interested working with an entity responsible for the Ph. Eur.?
Contact the Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).
Last updated on: 07.12.2012
Working with the entities responsible: Ph. Helv.: Who can I contact if I am interested working with an entity responsible for the Ph. Helv.?
Contact the Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).
Last updated on: 07.12.2012
More questions? Do you have more questions?
Just ask us. The team from the Pharmacopoeia division would be pleased to assist you if you have any further questions.
Last updated on: 01.07.2016