Publications

Preparation of Professional Publications of the Agency

The struggle for the preservation of health, rational pharmacotherapeutic approach and evidence-based treatment are priorities in every community.

Article 3 of the Law on Medicines and Medical Devices (“Official Gazette”, No. 30/2010) stipulated that ALIMS shall also “prepare professional publications of the Agency”. Designated jobs require continuous work on the development of appropriate local guidebooks as local reference manuals for physicians and pharmacists, and constant monitoring of innovations in the medical and pharmaceutical practice.

All these publications are distributed by the publishing, production, trade and services enterprise:

NATIONAL MEDICINES REGISTRY – NRL 2018

TREF TREID D.O.O.
BEOGRAD, Visokog Stevana br. 4
Phone +381 11 67-67-175; 064/18-48-211; 064/11-91-200
milanpavlovic@bvcom.net
ttvlada@gmail.com

NRL 2018 – ORDER – TREF TREID D.O.O.

NIJANSA D.O.O.
KONTAKT OSOBE: Slavojka Blecic, Milos Blecic
ZEMUN, Zadrugarska 14A
Phone +381 11 21-92-831; 21-97-896; +381 64 64-40-667
nijansa@eunet.rs

NRL 2018 – ORDER – NIJANSA D.O.O

PHARMACOTHERAPY GUIDE 6 + CD

TREF TREID D.O.O.
BEOGRAD, Visokog Stevana br. 4
Phone +381 11 67-67-175; 064/18-48-211; 064/11-91-200
milanpavlovic@bvcom.net
ttvlada@gmail.com

FV6 – ORDER

MARKETING AND CONSUMPTION OF MEDICINAL PRODUCTS FOR HUMAN USE, year 2018

TREF TREID D.O.O.
BEOGRAD, Visokog Stevana br. 4
Phone +381 11 67-67-175; 064/18-48-211; 064/11-91-200
milanpavlovic@bvcom.net
ttvlada@gmail.com


Publications are available in the following bookstores:

1. “Data Status”, BEOGRAD

Dr Subotića 3, Phone +381 11 3614916

2. “GRAFOPAN”, BEOGRAD

Vojvode Stepe 8, Phone +381 11 2495578

3. “DANILO KIŠ”, SUBOTICA

Desetog oktobra 2, Phone +381 24 556543

4. “SOLARIS”, NOVI SAD

Sutjeska 2, SPENS, Phone +381 21 6624387, 063/ 523351

5. “KNjIŽARA STAMENKOVIĆ”, NIŠ

Ćirila i Metodija 28, Phone +381 18 528 132, 063/ 747293

6. “MOST”, KRAGUJEVAC

Dr Zorana Đunđića 2, Phone +381 34 803715



NATIONAL MEDICINES REGISTRY (NRL)

One of the more important entrusted tasks within the activities of the Agency pertains to the provision of information to health-care professionals on registered medicinal products in the form of an appropriate professional guidebook. Given the constant changes and new developments in this field, it was justified for the National Medicines Registry issued by the regulatory institution of Serbia to be a publication which will be prepared annually with appendices prepared during the year which follow changes in this field.

The first edition of the National Medicines Registry of the Republic of Serbia (NRL) was prepared in January 2006, based on previously available data.

The organization of data and information on medicinal products has followed the Anatomical-therapeutic-chemical classification of medicinal products (ATC) in order to unify the key parameters for the efficient functioning of the Health or Pharmaceutical Information System respectively in the operations of health-care institutions, monitoring of marketing and consumption of medicinal products, planning medicines demand and monitoring of other indicators for the improvement of national policies on medicinal products, pharmacoeconomics, pharmacoepidemiology and the establishment of a national information system for medicinal products.

Over time, it was proved that the concept and methodology for preparation were suitable for modern conditions of work and business, and new chapters were introduced based on practical suggestions so a conceptualized handbook profile was created which provides key information on the medicinal product necessary at the moment of communication with patients/clients, as well as for further work, development and functioning of all parties in pharmaceutics.

The National Medicines Registry for the current year includes information on medicinal products with decisions of registration issued by ALIMS (marketing authorizations), i.e. which have valid decisions in the year for which NRL is prepared. The starting point for the development of NRL is the ALIMS Medicines Database based on regulatory documentation, and also other reference sources of information are used.

The main part of NRL is an Alphabetical list of registered medicinal products with identification data, parallels and a brief description of the indicated areas and dosage, as well as with specific data within the profile of medicinal product. Data and a brief description of the medicinal products are given in separate chapters which are classified as medicinal products of herbal origin, traditional medicinal products, traditional herbal medicinal products, homeopathic medicinal products, and have passed regulatory evaluation in ALIMS.

For purposes of patient/client safety, easier identification of medicinal product, monitoring of its marketing, and particularly for elimination of possible fake (counterfeit) medicinal products, NRL contains information data (ID data) for all medicinal products in the form of a 13-digit number representing the EAN code, which is clear and unambiguous identification of a particular medicinal product.

It should be noted that each new edition of NRL contains information about the changes and new labels, i.e. ATC classification codes of medicinal products for the current year in order to provide easy access to data and opportunity for all parties to respond promptly with regard to changes in this segment.

Easier search for a required term is enabled by the preparation of special lists, as follows:

  • Alphabetical list of registered medicinal products that can be issued without prescription (BR);
  • Alphabetical list of registered medicinal products classified in the group of narcotics and psychotropic substances with monitored marketing;
  • Alphabetical list of medicinal products that have a strong impact on psychophysical abilities and where driving and using machines during therapy is not allowed;
  • Alphabetical list of medicinal products that may affect the psychophysical abilities;
  • Anatomical-therapeutic-chemical classification of medicinal products with associated medicinal products;
  • Anatomical-therapeutic-chemical classification of herbal medicinal products;
  • Alphabetical list of International Non-proprietary Names (INN) with associated medicinal products;
  • Alphabetical list of non-proprietary names of herbal medicinal products;
  • Information on reporting adverse reactions to medicinal products with Report Form;
  • Substandard and counterfeit medicinal products;
  • List of new standard terms of pharmaceutical forms;
  • Alphabetical list of manufacturers with an assortment;
  • Alphabetical list of marketing authorization holders with addresses and the manufacturers they represent.

Like in other publications of this type, the Medicinal Product Proprietary Name Index and the Medicinal Product Non-proprietary Name Index enable locating necessary information depending on the contents of the information request. The method of processing and presentation of data is adapted for the requirements of health-care professionals and other parties in the pharmaceuticals, as well as to the experiences in this area. Information is adapted for the purpose – convenient and fast access to the information on medicinal products.

NRL is also prepared as a CD version in order to provide the conditions for more efficient work on prescribing and dispensing of medicinal products.

MARKETING AND CONSUMPTION OF MEDICINAL PRODUCTS FOR HUMAN USE

In accordance with the Law on Medicines, ALIMS collects and processes data on marketing and consumption of medicinal products in Serbia and publishes them annually. These publications contain health, economic and statistical indicators, as well as pharmacoepidemiological indicators of medicinal product use from which the analysis can be performed, all with the goal of being useful to the state institutions as well as to all participants in the medicinal product market in Serbia.

PHARMACOTHERAPY GUIDE (FV)

Pharmacotherapy Guides aim to establish the principle of better prescription strategy, good management in medicinal product prescription practice, as well as providing information to the prescribers on available therapeutic procedures.

The first issue of Pharmacotherapy Guide was prepared in 2001 as the first publication of its kind in our country, and the basic premise during its preparation was related to the making of a professional reading material which helps the therapist – prescriber to identify a disorder and to have information on rational therapy for the disorder in question. Information on advising patients and users of their services is important for experts prescribing medicinal products, especially nowadays, in modern health-care.

The methodological approach in the course of preparation is adapted to new trends in classification and identification of medicinal products, which provides international recognition and unambiguous comparison of key parameters critical for the development of pharmacotherapy and pharmacoepidemiology in our community.

By monitoring the improvement process in the field of rational pharmacotherapy and actual data collection, each new issue of Pharmacotherapy Guide provides new knowledge, innovated content and makes available new and current information to health-care professionals.

The Guide is divided into several chapters. The first chapter covers the principles of modern pharmacotherapy, clinical pharmacology objectives, basic principles of medicinal product pharmacokinetics, with special emphasis on the importance of administering the original unchanged pharmaceutical formulations of medicinal products, and the field of self-medication is displayed in accordance with current trends in the world and in a broader sense provides information about the so-called OTC products, i.e. medicinal products intended for self-medication. The key information is specified in connection to the principles and methodology of monitoring adverse reactions to medicinal products, and the basic principles of pharmacoeconomics and pharmacoepidemiology are also provided.

The special part is the most comprehensive and includes classification of medicinal products according to the ATC (14 groups by diseases of organ systems), by the International Non-proprietary Name (INN) of each medicinal substance, with more detailed specification of expert information on the corresponding medicinal product to each group with an overview of medicinal products registered in our country. Information about each medicinal product is organized according to a unique model which provides easy and quick data search and which provides a pharmacotherapeutic profile of the medicinal product, stating key information regarding indications for use, contraindications, side effects, interactions, dosage and special warnings or restrictions, and also specifies data on Defined Daily Doses (DDD) for each INN. In addition, current pharmacotherapeutic guidelines are provided for some groups of medicinal products.

Other chapters are intended for special areas of pharmacotherapy and provide a series of tabular displays which allow for a quick and simple way to find the necessary information on the required expert issue. These are as follows:

  • Use of medicinal products in children,
  • In geriatrics,
  • Use of medicinal products in pregnancy and during lactation,
  • In liver and kidney diseases, as well as administration of medicinal products to patients undergoing peritoneal dialysis,
  • Therapeutic protocols for the treatment of certain diseases,
  • Effect of medicinal products on the functions and systems outside the indicated area (photosensitivity due to medicinal products, sexual dysfunction caused by medicinal products, review of medicinal products that potentiate skin disorders).

Tabulated data is presented on the influence of medicinal products on the results of clinical and biochemical parameters, medicines for rare indications (Orphan medicinal products), and a table with an overview of clinically significant interactions of medicinal products is also provided. Information on the lesser-known segment – homeopathy, traditional medicinal products is also summarized, with a list of these products registered in the Republic of Serbia.

Therapeutic protocols are also specified for the treatment of some diseases, and the text regarding the principles of “good practice” provides wider knowledge to the medical and pharmaceutical public on important segments that contribute to the improvement of health-care in general, and the current Rulebook on prescription and dispensation of medicinal products is also provided.
The final chapter offers an overview of the current Anatomical-therapeutic-chemical classification of medicinal products (ATC – WHO) with data on the daily defined doses (DDD) in order to provide research data to the parties interested in the field of pharmacoepidemiology and pharmacoeconomics.

A multidisciplinary team of scientific and medical experts from a number of institutions of Serbia was involved in the drafting of the Guide and is prepared to continuously innovate every new issue of FV in accordance with the professional requirements and changes in the pharmaceutical and medical fields.

PUBLICATIONS FOR THE GENERAL PUBLIC

ALIMS is actively involved in the education of professional and general public about the importance of particular fields of its expertise.
To this end, in December 2011, ALIMS has conducted an informative campaign in the media regarding the importance of clinical trials and has published a brochure for the participants and potential participants in the clinical trials.

Vocational Meetings

Medicines and Medical Devices Agency of Serbia has organized vocational meetings with the goal of providing information to the professional public.

You can find information on the vocational meetings to be held in the future under the “Announcements of Workshops and Events” located on the main page of the website.