Pharmacopoeia

Regulations

Pharmacopoeia

European Pharmacopoeia Commission

At the end of the 1950s in Europe, there was a need to compile specifications for an increasing number of new medicinal substances, as well as to harmonize specifications for existing medicinal substances and pharmaceutical dosage forms. For this reason, the member countries of the Council of Europe decided to establish a common pharmacopoeia, which will be called the European Pharmacopoeia, and whose monographs will become official standards in those countries. In 1964, the Convention on the Elaboration of the European Pharmacopoeia was adopted in Rome, according to which the elaboration of the European Pharmacopoeia is carried out by: The Public Health Committee, whose activities are carried out within the framework of the Council of Europe. European Pharmacopoeia Commission, established by the Committee for Public Health. The Commission of the European Pharmacopoeia is made up of national delegations of member states of the Council of Europe, consisting of a maximum of three members and the same number of alternates. In 1990, SFRJ passed the Law on the Ratification of the Convention on the Creation of the European Pharmacopoeia, thereby becoming a member of the European Pharmacopoeia and acquiring the conditions to attend the Commissions. Serbia, as the legal successor of the SFRJ, continued to participate in the work of the European Pharmacopoeia and applies the requirements of the European Pharmacopoeia on its territory.

EDQM

The European Directorate for the Quality of Medicines and Healthcare (EDQM) was founded in 1996 as a Directorate of the Council of Europe.

EDQM is responsible for:

technical secretariat of the European Pharmacopoeia Commission
publication and distribution of the European Pharmacopoeia
preparation and distribution of Chemical Reference Substances (CRS) and Biological Reference Preparations (BRP)
certification of suitability of European Pharmacopoeia monographs (CEP)
the European network of control laboratories (Official Medicines Control Laboratories, OMCL)

OMCL Network

European network of control laboratories (General European OMCL network, GEON) (hereinafter – OMCL network) It was formed in the mid-1990s under the auspices of the Council of Europe with the aim of strengthening cooperation and building mutual trust among the control laboratories of Europe. The role of the OMCL network is to harmonize work processes and to improve the exchange of data and results obtained in various activities in the sphere of quality control of medicines.

General activities, which are open to all members of the OMCL network, are:

QA activities – which have a role in the development and implementation of the QA system (ISO 17025) in all members of the OMCL network.
Market Surveillance Scheme (MSS) – represents a study that is carried out on products that are already on the European market, with the aim of determining and ensuring that the same type of product has the appropriate quality in all countries.
Proficiency Testing Scheme (PTS) – is a comparative examination of the same sample from different OMCLs, which is carried out to ensure comparability of results obtained in different laboratories within the OMCL network, thus helping to build mutual trust within OMCL.
Various education programs
Development of existing regulations and analytical research

Specific activities based on the process of mutual recognition, which are open only to members of the European Union:

Tests conducted during the Centralized Authorized Procedure (CAP)
Tests that are conducted during the Mutual Recognition Procedure (MRP) or Decentralized Procedure (DCP).
Batch release of biological preparations (Official Control Authority Batch Release, OCABR)

Meetings of the OMCL network are held once a year in one of the member countries and the activities and program are presented at them. The National Control Laboratory, as part of the Medicines and Medical Devices Agency of Serbia (ALIMS), is a full member of the OMCL network.

Since March 2002, the ALIMS has its members in the Serbian delegation who regularly attend the Commissions of the European Pharmacopoeia. Commission meetings are held in Strasbourg, France, three times a year (March, June, November).

Also, employees from the Agency, based on their competencies in certain areas, actively participate in the work of certain groups of experts, who are engaged in the development and updating of monographs of the European Pharmacopoeia.

In order to further expand cooperation with other members of the OMCL network and to acquire and exchange experience in this area, employees from the National Control Laboratory regularly attend the annual meetings of the OMCL network. Within the OMCL network, the National Control Laboratory participates in the following activities:

PTS studies
MSS studies
Determination of the quality of chemical reference substances produced by the European Pharmacopoeia
Development of European Pharmacopoeia monographs

Standard Terms

Standard terms are used to define, in a uniform, i.e. standardized way, certain elements of the drug, including the pharmaceutical form (Dosage form), route and method of administration (Route or method of administration) and packaging (container, closure and means for administering the drug ). Also, standard terms include combined terms, which are used for two or more components of the drug that are packaged together, which include:

Combined pharmaceutical forms (two or more products, which are combined with the aim of obtaining a pharmaceutical form that is administered to the patient)

Combined term (when the container is mentioned in the name of the pharmaceutical form)

Combined packaging (two or more pharmaceutical forms are packaged together and administered as independent products)

Units of presentation are standard terms that can be used to express the strength or quantity in a unit of a drug in a certain type of container or in a certain pharmaceutical form.

Terms for patients (patient friendly terms) are shorter forms of standard terms, which can be approved by the Agency, and which can be used to label the drug in case of insufficient space for specifying data.

The database of standard terms contains terms and definitions for the description of pharmaceutical forms, routes and methods of drug administration, containers, closures, means of drug administration and presentation units.

The list of standard terms is approved by the European Pharmacopoeia Commission, based on the request of the EU Commission, for use when submitting a request for drug registration, in the appropriate documents related to information about the drug (Summary of the characteristics of the drug, Instructions for the drug and text for packaging marking). Currently, there are translations of the Ph. Eur. standard terms in 34 languages (and are included in the database of standard terms). Standard terms have a dual purpose – they represent information for patients/users/prescribers or they serve to differentiate medical products that have the same name.

How to access the database of standard terms

In order to access the database of standard terms, it is necessary to have an account that is created on

the EDQM website – EDQM Publications registration website (Register).

The database of standard terms can best be opened with the latest version of Mozilla Firefox, Safari, Google Chrome or Internet Explorer.

List of standard terms (Standard Terms)

Standard terms related to tests, methods and requirements (link)

Database: https://standardterms.edqm.eu.

In the upper right corner there is a link for “login” where already registered users can log in via e-mail address and password. New users must first create an account at the EDQM HelpDesk Publications Registration link https://www.edqm.eu/register/ (or log in to an existing account) where they register for free access to the database of standard terms.

The search in the database of standard terms can be performed based on the state in which the pharmaceutical form is found (solid or liquid pharmaceutical forms), based on the method of release of the active substance, the place of application of the drug or the method of administration of the drug.