European Pharmacopoeia Commission
The European Pharmacopoeia Commission (Ph. Eur. Commission) is a Council of Europe's working body responsible for elaborating a European Pharmacopoeia. It is established at the European Directorate for the Quality of Medicines and HealthCare - EDQM, in accordance with obligation resulting from the signing of the Convention on the Elaboration of a European Pharmacopoeia (Convention).
Delegation members
The Ph. Eur. Commission is composed from delegates from signatory states to the Convention.
Every delegation is composed of maximum three members elected based on their competence on issues encompassed in the framework of the Ph. Eur. Commission's functions. Every delegation may have equal number of alternate members with similar competences.
The Croatian delegation is composed of two regular and one substitute member.
Delegation members regularly attend meetings of the Ph. Eur. Commission at the EDQM and participate in the work of the Ph. Eur. Commission between sessions.
Delegation members responsibilities
- Follow up of documents (new, revisions or corrections of general articles and Ph. Eur. monographs) in the meeting's agenda
They may estimate the relevance of discussing documents with the National Pharmacopoeial Authority in Croatia (NPA) or with relevant experts in certain fields encompassed by these documents in order to take a scientific position regarding the concerned topic and when necessary presented in Ph. Eur. Commission's meetings. - Proposals for introduction/revision/deletion of a monograph or general article
National proposals related to introduction, revision or deletion of a monograph or general topic are sent via delegation to the Ph. Eur. Commission. Interested parties in the country proposer should send their proposals, substantiated with relevant data, to their NPA. After agreeing on all proposals, the NPA decides which proposals will be sent via delegation to the Secretariat of the Ph. Eur. Commission. The attached data should enable the Ph. Eur. Commission to judge the relevance of the request for revision and make a decision on further steps. - Communication of Ph. Eur. delegates with the NPA
In case that the complexity of issues goes beyond the NPA resources, the concerned document is forwarded to the Croatian Pharmacopoeia Commission for further consideration and adoption of a scientific opinion. - Nominations of experts in the Ph. Eur. scientific groups and working bodies
When the Ph. Eur. Commission expresses the need for experts of certain profiles, the NPA finds and recommends competent professionals. Nomination proposals are sent via delegation to the Secretariat of the Ph. Eur. Commission. Nominations are either confirmed or rejected by the Ph. Eur. Commission. When nominating experts in the Ph. Eur. Commission's scientific groups and working bodies, the delegation reviews the candidate's experiences and competences that should be in line with the previously defined admission requirements of a certain working group. In the case of renomination, the candidate's previous contribution is also taken into account. The preference is given to candidates having access to the resources defined in conditions for becoming a group expert (i.e. laboratory access, access to certain analytical techniques and/or equipment, access to registration dossier etc.). - Reporting from meetings of the Ph. Eur. Commission
Representatives of the Croatian delegation prepare written reports for the NPA about the results of certain topics of the meeting agenda when they estimate that it is relevant for Croatian interests.
Ph. Eur. expert groups
The Ph. Eur. Commission also establishes permanent expert groups and occasional working bodies that voluntarily execute tasks of drafting and revision of the Ph. Eur. texts. New text proposals, corrections and revisions are forwarded by groups to the Ph. Eur. Commission for endorsement by voting. A proposal may be endorsed only unanimously.
In Ph. Eur. working groups and expert bodies there are four HALMED representatives, two from healthcare and one from the academic community (faculty). They currently participate in the work of the following working groups and expert bodies:
- Group 1 (Microbiology)
- Group P4 (Procedure 4)
- Group SIT (Second Identification Test)
- Group CTP (Cell therapy products)
- Group EDSForm (European Drug Shortages Formulary)
- Group 13A (Herbal Drugs and Herbal Drug Preparations)
The scope of the SIT group is very important for the future work of community and hospital pharmacies. Namely, due to requests of REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemical Substances) aimed at removing substances hazardous for humans and environment as much as possible, pharmacopoeial testing, especially secondary identification tests intended for pharmacies, are currently subject to important changes. We recognise the need to participate as a country in defining such testing that will be incorporated in new, or revisions of existing specific monographs.
Due to the extreme importance of the increasingly frequent situation with drug shortages, the working group for the European formulary for drug shortages includes two members from Croatian control laboratories - Zagreb City Pharmacies and Pharmacies of the Split-Dalmatia County.
