Medicinal Products

National Pharmacopoeia Authority

National Pharmacopoeia Authority (NPA) is one of the groups in the interested parties network coordinated by the European Pharmacopoeia Commission (Ph. Eur. Commission).

Its responsibility is maintaining relevant communication with the European Directorate for the Quality of Medicines & Health Care (EDQM) in compliance with the Convention on the Elaboration of a European Pharmacopoeia, on one side and local Ph. Eur. users on the other.

Alongside the NPA, delegates, experts, specialists, the EDQM Secretariat, European organisations, industry, universities and other parties participate in the work of the Ph. Eur. Commission.

The communication with EDQM is formally performed by the NPA Secretary appointed by HALMED which is the NPA in Croatia.

The address of the National Pharmacopoeia Authority is:
Agency for Medicinal Products and Medical Devices
Ksaverska cesta 4
10000 Zagreb
Phone: 01 4884 129
Fax: 01 4884 110
E-mail: UredZaFarmakopeju@halmed.hr

NPA responsibilities

1. Providing comments to drafts of monographs and other texts of the Ph. Eur. Commission within statutory deadlines.
2. Recommending fundamental changes in well documented text drafts and wherever possible substantiated by experimental data.
3. Supplementing every comment with recommendations for improvement with the clear indication of expected action and the reason for it.
4. Maintaining communication between experts in the country, having respect to their independent status.
5. Implementing decisions of the Ph. Eur. Commission at the national level.

NPA tasks

1. Participation in creation and revision of the Ph. Eur. monographs by:
   
   - ensuring the scientific support at monograph developments;
   - gathering of information on medicinal products status on the local market;
   - transferring information on Pharmacopoeia to the local level;
   - connecting interested parties and the EDQM at the local level.
2. Preparation for implementing the Ph. Eur. and its supplements at the local level
   With this aim the NPA prepares the Croatian Pharmacopoeia with translations of the most commonly used texts in Croatian and thus facilitates the use of European standards in practice. The NPA secretariat provides education on the Pharmacopoeia, as well as informing and consultation.
3. Answering to the EDQM queries concerning the Ph. Eur. work. Queries may refer to opinions whether a certain monograph should be revoked, if a certain substance is not in use anymore.
4. Providing information on local manufacturers and other interested parties willing to contribute to the work, respecting the necessary degree of confidentiality.
5. Providing information to its expert groups and local manufacturers, when needed, on upgraded text drafts, respecting the necessary degree of confidentiality. Even though it is expected from end users to keep track of updates in the Pharmacopoeia, a direct communication and indication to changes may help in avoiding eventual oversights from both parties before final endorsement of new texts.
6. Critical assessment of national comments to the text drafts published in Pharmeuropa and their forwarding to the EDQM. It is expected from all local users to forward their proposals and comments to the Ph. Eur. via the NPA that has a broader insight into this area and can therefore more objectively estimate the justification for certain proposals and comments.
   A critical review means that the decision on which proposals and comments obtained from users will be forwarded to the Ph. Eur. Commission should be taken in the most objective way keeping in mind the general benefit for the patient.
   Also, the NPA critically evaluates and forwards to the EDQM proposals for creation of new texts/monographs, technical queries concerning certain monographs and suspected derogations in monographs received from users at the local level.
7. Providing instructions to members delegated to the Ph. Eur. ahead of meetings on the topics of national interest.
8. Forwarding proposals to experts and specialists, members of expert groups and working bodies.
9. Monitoring the work of experts and specialists in their respective groups.
10. Attending annual NPA meetings organised by the EDQM to facilitate and coordinate activities of common interest and ensure the information exchange with other NPAs.
11. Informing the Ph. Eur. Commission on the creation of national texts, if applicable.

National texts are generally created in narrow specific fields applicable exclusively in one signatory state to the Convention on the elaboration of Pharmacopoeia, when this field is not covered by the Ph. Eur. If the same need arises in another signatory state, the Ph. Eur. Commission considers the requirement to introduce this text in the Ph. Eur.

In order to successfully perform the activities of the NPA, HALMED has established the Croatian Pharmacopoeia Commission (HRF Commission) that facilitates the information exchange between end users of the Pharmacopoeia and the Ph. Eur. Commission.