About the EDQM & Healthcare
The EDQM & Healthcare has until now granted three CEPs (Certificate of Suitability under the European Pharmacopeia) to FeF Chemicals A/S:
- one for
Benzalkonium Chloride Ph.Eur.,
- one for
Benzalkonium Chloride Solution 50% Ph.Eur. and
- one for
Cetrimide Ph.Eur.
The EDQM & Healthcare is responsible for the Technical Secretariat of the European Pharmacopoeia (Ph.Eur.) Commission. The Technical Secretariat is in charge of preparing and publishing adopted texts, distributing the European Pharmacopoeia and checking the texts experimentally in the laboratory.
The
EDQM
& Healthcare is also responsible
for activities related to the procedure for the certification of suitability
of European Pharmacopoeia monographs. The new Directive of the European
Union (Directive 2003/63/EC) makes it obligatory for marketing authorisation
dossiers for medicines to refer to the specific and general monographs of
the European Pharmacopoeia; it also mentions the use of Certificates of
Suitability (CEP) of monographs of the European Pharmacopoeia in
applications for marketing authorisation to demonstrate that the substances
used by the manufacturers comply with specifications.
A Certificate of Suitability (CEP) guarantees that the application of the relevant European Pharmacopoeia monographs make it possible to demonstrate that the quality of the substance is appropriate for use in medicines. In other words, it guarantees that all the impurities and potential contaminations related to the manufacturing process (including the manufacturing site and raw materials) are satisfactorily controlled using the requirements of these monographs. The certificates granted in Strasbourg by the EDQM & Healthcare are recognised by the 36 European states that have signed the European Pharmacopoeia Convention, by the European Union in its directives and by other countries on a voluntary basis. They can be used by manufacturers of pharmaceutical products in their dossiers for marketing authorisation to demonstrate that their products comply with the requirements of the European Pharmacopoeia monographs and with the revised EU directives that concern the substances they use to produce their medicines.
Member and Observership
36 parties to the Convention
36 member states with member status (including the 24 states of the European Union).
This status enables to participate in the sessions of the
European Pharmacopoeia Commission.
A member state shall take the necessary measures to ensure that the texts
adopted and which will constitute the European Pharmacopoeia shall become
the official standards applicable within its country.
20 Observers
European countries, Non-European countries and the WHO (World Health Organisation).
The observer status enables to participate in the scientific work of the Commission, to benefit from European experience in this area and to gain access to work on the quality control of medicines and the methods of analysis used. The observers referred have the right to speak; they may not, however, make proposals unless these are put forward by one of the delegations referred.
