FAQ

Ph. Eur.    Pharmacopoeia Europaea (European Pharmacopoeia)
Ph. Helv.   Pharmacopoeia Helvetica (Swiss Pharmacopoeia)

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.

• 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 39 Member States plus the EU as an organisation. In addition, 29 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 39 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"

• 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 staff members 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"

Book

• German and French: Federal Office for Buildings and Logistics (BBL), Publications Dept., 3003 Bern
• English: EDQM, F-67081 Strasbourg

Data carrier

• DVD + online access German; Federal Office for Buildings and Logistics (BBL), Publications Dept., 3003 Bern

Online version

• French and English: EDQM, F-67081 Strasbourg
• German: Online access is purchased with the DVD

Further information > www.bundespublikationen.admin.ch (EDI, Swissmedic) or www.edqm.eu/store/

Online version

• Access to the online version of the Ph. Helv is available free of charge at www.phhelv.ch.
  
  

Book (must be purchased)

• German, French, Italian: Federal Office for Buildings and Logistics (BBL), Publications Dept.; 3003 Bern

Further information > www.bundespublikationen.admin.ch (EDI, 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)

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.

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 > Licences > 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.

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.

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.

Ph. Eur.

• Please contact the Swissmedic Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).

Ph. Helv.

• Please contact the Swissmedic Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).

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

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)

The Ph. Helv. is drafted and published by Swissmedic, the Swiss Agency for Therapeutic Products.

Further information > www.bundespublikationen.admin.ch (EDI, Swissmedic)

The Agency Council is responsible for the entry into force of the Ph. Eur. and
Ph. Helv. by means of an Agency Council 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. normally enters into force, in the three official languages, every three years; the Agency Council Ordinance is therefore modified and re-enacted approx. three times per year.

Further information > www.swissmedic.ch > Pharmacopoeia > Legal texts > Ordinance of the Swiss Agency for Therapeutic Products of 9 November on the Elaboration of the Pharmacopoeia and the Recognition of Pharmacopoeias (SR 812.214.11)

The currently valid date for the entry into force can be found on the Swissmedic website.

Further information > www.swissmedic.ch > Pharmacopoeia > Dates of entry into force

Ph. Eur.

• French and English: the work is published by the Council of Europe, which also establishes the price.
• German: Steps are taken in Switzerland to ensure that the Ph. Eur. costs the same in German and in French.

Ph. Helv.

• The online version is available free of charge at www.phhelv.ch. The book version must be purchased.

Further informationà Federal Law of 18 June 2004 on the Compendium of Federal Law and the Federal Gazette (Publications Act, PublG; SR 170.512), https://www.fedlex.admin.ch/

No. Since 1 January 2012, Pharmeuropa is only available as an online version, and is free of charge (previously only for purchase, in the print version).

Further information > Pharmeuropa Online (edqm.eu)

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)

Contact the Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).

Contact the Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).

Contact the Pharmacopoeia division (Pharmacopoeia@swissmedic.ch).

Details of how a Ph. Eur. monograph is elaborated can be found on the EDQM website.

Further information > How to participate in the work of the Ph. Eur. - European Directorate for the Quality of Medicines & HealthCare (edqm.eu)

Details of how a Ph. Helv. monograph is elaborated are on the Swissmedic website.

Further information > www.swissmedic.ch > Pharmacopoeia > Elaboration of the 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.

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 around 2,500 single monographs.
The Ph. Helv. contains around 150 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 39 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"

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"

The Pharmeuropa is the publications entity of the EDQM (European Directorate for the Quality of Medicines and HealthCare). Among other features, draft monographs from the Expert and Working Groups are published for public consultation.

Further information > Pharmeuropa Online (edqm.eu)

See "Obtaining a copy of the Ph. Eur."

See "Obtaining a copy of the Ph. Helv."

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.

• Convention of 22 July  1964 on the elaboration of a European Pharmacopoeia (State contract; SR 0.812.21)
• Protocol of 16 November 1989 to the Convention on the elaboration of a European Pharmacopoeia (SR 0.812.211)
• Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA, SR 812.21)
• Ordinance of 17 October 2001 on the Pharmacopoeia (Pharmacopoeia Ordinance, PhaV; SR 812.211)
• Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the enactment of the Pharmacopoeia and the Recognition of Pharmacopoeias (SR 812.214.11)

Further information > www.swissmedic.ch > Pharmacopoeia > Legislation

See "Forms of publication"

See "Forms of publication"

No. The publication is part of national law and therefore published in the official languages of Switzerland, meaning German, French and Italian.

Ph. Eur.: Please contact the Help desk via the EDQM website (www.edqm.eu).
Ph. Helv.: Please select the "Help" section at www.phhelv.ch.

Just ask us. The team from the Pharmacopoeia division would be pleased to assist you if you have any further questions.