Alims.gov.rs

Registration in the Register of Medical Devices – ALIMS

WebRegistration in the Register of Medical Devices Within the system of health-care service provision, and for the purposes of disease prevention, diagnosis, treatment, and …

Actived: 7 days ago

URL: https://www.alims.gov.rs/english/medical-devices/registration-in-the-register-of-medical-devices/

Regulations – ALIMS

WebRegulations It is a field of both general and particular social interest; It is in a direct function of health care protection i.e. enhancement and protection of human health, early …

Category: Health Go Health

ALIMS – Medicines and Medical Devices Agency of Serbia

WebApplications are open and the program of the 18th ALIMS International Annual Symposium has been announced The Agency for Medicines and Medical Devices of Serbia …

Category: Medical, Medicine Go Health

Marketing and consumption of medicinal products – ALIMS

WebMarketing and consumption of medicinal products Collecting and processing data on marketing and consumption of medicinal products and medical devices Activity of the …

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Rulebook on the method of reporting, collecting and

WebArticle 1. The Rulebook shall prescribe the method of reporting, collecting and monitoring adverse reactions to medicines in human use (hereinafter referred to as the …

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Information on medicines – ALIMS

WebIn the procedure of marketing authorization issuance, as an integral part of the marketing authorization, ALIMS approves the Summary of Product Characteristics (SmPC) and …

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Medicinal Products – ALIMS

WebMedicinal Products Medicinal product is a product containing a substance or a combination of substances produced and intended for the treatment or prevention of diseases in …

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Function and activities – ALIMS

WebThe Medicines and Medical Devices Agency of Serbia, performs the activities of organized and continual monitoring of adverse reactions to medicinal products, by applying the …

Category: Medical, Medicine Go Health

About Agency – ALIMS

WebAbout the Agency Medicines and Medical Devices Agency of Serbia was founded by the Law on Medicines and Medical Devices (Official Gazette of the Republic of Serbia No. …

Category: Medical, Medicine Go Health

Reporting an adverse reaction to a medical device (INCIDENT)

WebMedicines and Medical Devices Agency of Serbia 458 Vojvode Stepe Street, Belgrade 11221, Serbia Fax +381 11 3951 131, +381 11 3951 147 web: www.alims.gov.rs e-mail: …

Category: Medical, Medicine Go Health

Veterinary Medicines – ALIMS

WebVeterinary Medicines Medicinal product is a product containing a substance or a combination of substances produced and intended for the treatment or prevention of …

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Medical Devices Vigilance – ALIMS

WebMedical device vigilance is a set of activities related to the collection, evaluation, understanding and response to the knowledge about the risks arising from the use or …

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Clinical Trials – ALIMS

WebMedicines and Medical Devices Agency of Serbia 458 Vojvode Stepe Street, Belgrade 11221, Serbia Fax +381 11 3951 131, +381 11 3951 147 web: www.alims.gov.rs e-mail: …

Category: Medical, Medicine Go Health

Reporting of Adverse Drug Reactions – ALIMS

WebAdverse drug reaction reporting is the main method for post-marketing surveillance of a medicine which leads to new insights about its safety profile. The …

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Rulebook on the Contents of the Application, and/or

WebНа основу члана 78. Pursuant to Article 78, paragraph 3 and Article 199 paragraph 3 of the Law on Medicines and Medical Devices (“Official Gazette of the RS”, nr. 30/10) The …

Category: Medical, Medicine Go Health

LAW ON MEDICINAL PRODUCTS AND MEDICAL DEVICES I.

Web20) Clinical trial sponsor is an individual or a legal entity that takes responsibility for commencing, conducting, and/or financing a clinical trial;

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Pharmacovigilance – ALIMS

WebThe ultimate goal of pharmacovigilance is to protect public health by putting patient safety first. Therefore, pharmacovigilance is considered an essential part of medicines …

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I INTRODUCTORY PROVISIONS Article 1

Web4 (6) defining or monitoring therapeutic measures. Sample receptacles are considered to be in vitro diagnostic medical devices. Sample receptacles are vacuum- or non-vacuum …

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