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AGENCY FOR MEDICINES AND MEDICAL DEVICES (ALIMS)

1. Role and competences of the Agency

Agency for Medications and Medical Devices of Serbia, according to the Law of Medications and Medical Devices (OG RS 30/210) is competent to do the following:

- issue licenses for the medicament, decide on amendments, renewal and transfer, as well as termination of the license for the medicament;
- performs entry of the medical device into the Register of Medical Devices, decide on the amendments, renewal of entry and erasure of medical device from the Register of Medical Devices;
- performs entry into the Register of Traditional Plant Medicaments, or entry into the Register of the Homeopathic Medicaments;
- issues licenses for the conducting of the clinical examination of medicament and medical device and decides on the amendment of the license or protocol on the conducting of clinical examination of medicaments, passes decision with regard to the application for clinical examination, performs control of the conducting of clinical examination;
- follows undesired reactions to medicaments (pharmaco-vigilance) and the undesired reactions to medical devices (vigilance to medical devices);
- issues certificate for the need of export of medicaments and medical devices in compliance with the recommendations of the World Health Organization;
- approves import of medicaments and medical devices for the treatment of a particular patient or group of patients, as well as medicaments or medical devices for scientific and medical research;
- performs categorization of medicaments or medical devices;
- performs gathering and processing of data on the marketing and expenditure of medicaments and medical devices;
- gives information and proposals for the rational use of medicaments and medical devices;
- connects with the international information network on the medicaments and medical devices and with the agencies competent for medicaments and medical devices and their associations;
- participates in the planning and enforcement of systematic control of medicaments and medical devices and the obtaining of chance samples from the channels of commerce;
- gives opinions for the import and export of the samples of cells, or tissues for the procedure of clinical examination by medicaments;
- performs quality control of medicaments and medical devices;
- prepares expert publications from the competencies of the Agency; performs other tasks in compliance with the Law.

ALIMS actively participates in the development of the pharmaceutical activities in Serbia, elaboration of by-laws, further building up of national policy in the field of medicaments and medical devices and international cooperation.

2. IPR enforcement tasks

Tasks of ALIMS with regard to IP rights enforcement refer primarily to the protection of data regarding information for medicaments used in human medicine. ALIMS, in the procedure of issuing license for medicament, controls if there is protection of data for that medicament. If the license for the medicament has been issued for the first time in the Republic of Serbia or the countries of the EU, in compliance with the Law on Medicaments and Medical Devices and regulations passed for the enforcement of the law, or in harmony with the requests of the EU, for the referent medicament, and every new license for the medicament on the basis of the amendment of the existing license for the medicament with regard to the strength of the medicament, pharmaceutical form, manner of implementation of the medicament, package, as well as other variations and requests for the extension of license for medicament, should be included in the first license for the medicament and form part of the unified, global system of issuing license for the medicament (Global license for the medicament).

Proponent for the issuing of license for the medicament with shorter documentation can file request for the issuing of license for the medicament at the expiry of at least eight years from the date when the global license for the referral medicament has been issued in the Republic of Serbia, EU or countries which have the same or similar demands for the issuing of license. At the expiry of 10 years from the date of issuing the global license for the referral medicament, the proponent can obtain license for the medicament with the shortened documentation. The mentioned term of ten years is extended (cumulatively) for another year if in the course of eight years from issuing the global license for the referral medicament, the holder of license for the referral medicament obtained another license for one or more new indications which represent the significant impro val of therapy by that referral medicament. This term of one year refers to the holder of license for the medicament for which the complete documentation has been filed, and which obtained a new license for medicament for one or more new indications which represent a significant improval of therapy and on the basis of new pharmaceutical and toxicological and clinical research of that medicament as well as for the medicament for which new classification has been established on the basis of significant preclinical and clinical research in compliance with this Law.

Exceptionally, for veterinary medicaments used for the treatment of bees, fish and other less prominent animal kind, the mentioned term of one year can be prolonged cumulatively up to three years if deemed necessary. Also, if the new license is issued for the implementation of the referral medicament on another animal kind, the products of which are intended for human food in the period of five years from the date of issuing the license for that medicament, that term is prolonged for another year (cumulatively) and for the most for three years if used for the treatment of four animal kinds or more kinds of animals used as human food.

The terms of protection of data for medicaments start on the date when the global license has been issued for the medicament. The transitory provisions of the Law additionally define that until the entry of the Republic of Serbia into the EU, the producer of medicaments with the seat in the Republic of Serbia which is the holder of license for the medicament can obtain the license for the medicament after the expiry of six years from the date of issuing the first license for the referral medicament or after the expiry of term of ten years from the date of obtaining the first license for the biotechnological medicament.

With regard to the assessment of documentation for the issuing of license for the medicament, as well as alteration of license for the medicament which concerns the trademark, ALIMS consults the Intellectual Property Office.

3. Competences in fighting against counterfeit medicines and medical devices

ALIMS also has competences in the fight against pirated or false medicaments and medical devices. The Law defines a false medicament, or medical device as a pharmaceutical or medical device which is produced or manufactured or marketed or entered into the chains of commerce with the intention to deceive persons that use them or in any way offer treatment with the medicament or medical device or have false data on the identification (producer, place of production, holder of license for the medicament, or holder of entry into the register kept by the ALIMS, certificate on the analysis, as well as other data and documentation referring to the medicament or medical device)or which can contain correct or false components with regard to the composition from the declaration, or not contain the active substances, or not contain sufficient amount of active substances, or have false package like some other medicament or medical device which are considered a fake medicament or medical device according to the standards of the countries of the European Union or World Health Organization.

Patient, doctor or medical personnel, manufacturer of medicament or medical device, in the retail sales or in the trade of medicaments or medical devices, as well as the holder of license for the medicament or holder of entry into the Register which doubts the quality and safety of medicaments or medical devices, informs the competent ministry of his doubts. That can be done by filing an application which is found on the web site of ALIMS http://alims.gov.rs/cir/farmakoinformatika/lazni_lekovi.php and in the case of doubting the appearance of the false medicament, it is provided in the Regulations on the control of quality of medicaments and medical devices that it must be reported without delay.

On the basis of the report doubting the quality and safety of the medicament or medical device, out of turn control of quality is performed. It is done at the proposal of the inspector for medicaments and medical devices of the competent ministry and ALIMS for the sake of solving the noted problems (report on the doubt in the quality of medicament, or medical device or noted divergence from the quality standards). The request, together with the samples for the performance of out of turn quality control of the medicament or medical device is forwarded to ALIMS by inspectors for medicaments and medical device of the competent ministry with the explanation for its implementation.

Divergence from the quality standards can be reported to the competent ministry or ALIMS also by the international system of rapid information (RAN) and other regional, European and world networks and contacts. RAN – Rapid Alert Notification is the international system for rapid exchange of information used by the bodies or institutions competent for medicaments in the countries of EU European Economic Zone, European Directorate for Quality medicaments, Network of Inspectorate Cooperation (PIC/S) and the country (MRA) with which the European union has the agreement on mutual notification about the doubts of the medicament quality or the divergence form the standards of quality or the need to initiate the procedure of seizure of medicament or serials of medicaments.

Medicament of medical devices which have been found out, in the process of out of turn control of the quality of products, that there is divergence from the quality standards, the Agency forwards a certificate of the analysis to the competent ministry with the proposal to stop, ban marketing or seize the serial of that medicament or a serial of the medical device from the channels of commerce.

4. Contact

Agency for Medicines and Medical Devices of Serbia ALIMS
Vojvode Stepe 458, 11121 Beograd
Fax: (+381 11) 3951-131; (+381 11) 3951-147

Clerks Office
Phone: (+381 11) 3951-125, 3951-110
Fax: (+381 11) 3951-131

Director's Office
International Cooperation and PR
Mr. Pavle Zelic, M.Sc.
pavle.zelic@alims.gov.rs
Phone: (+381 11) 3951-183
Mobile (+381 69) 3233-623

Director's Office
Technical Assistant
Ms. Zeljana Mazic
zeljana.mazic@alims.gov.rs
Phone: (+381 11) 3951-107
Fax: (+381 11) 3951-181

For more information visit the Internet site of the Agency for Medicaments and Medical Devices (ALIMS) at the address http://www.alims.gov.rs/.