Services

Dietary supplements

• Preparing and submitting dossier for registration of food and dietary supplements in the Database held by the Serbian Ministry of Health (which includes the Faculty of Pharmacy’s expert opinion and product categorization, reference laboratory’s health safety report and qualitative and quantitative composition of dietary product)
• Submitting an application for a permit to place a novel food on the market of the Republic of Serbia
• Preparation and submission of the documentation for renewal of the registration after 5 years
• Activities related to changing the information of an already registered dietary supplement
• Preparation and submission of documentation for registration/renewal of dietary supplements in the Register of dietary supplements of the Ministry of Health of the Republic of Srpska, BIH (preparation of the declaration, obtaining an expert opinion on the registration of dietary supplements by the Public Health Institution for Public Health of the Republic of Srpska)

Chemical advisory

• Assistance in preparation of documentation necessary for registration of chemicals in the Register of Chemicals, in compliance with the regulations relating to the classification, packaging, labeling and advertising of chemicals.
• Assistance in preparation of a Chemical Dossier and Safety Data Sheet (SDS) in compliance with the Law on Chemicals.
• Informing the client about the provisions defined by the Law, as well as identifying substances that are exempted form the registration obligation

Marketing authorization

• Regulatory and procedural guidance on obtaining MA for placing a medicinal product on the Serbian market, as well as MA renewals and variations application.
• Preparing, evaluating and/or upgrading of registration dossier in accordance with the Serbian regulations.
• Submitting application and dossier for MA, renewal of MA, as well as for implementing variations to Medicines and Medical Devices Agency of Serbia (ALIMS).
• Labelling adjustments and implementation (Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL), Instructions For Use, Primary and Secondary package text).
• Follow-up procedures and communication with the ALIMS representatives until acquiring marketing authorization or authorization renewal for the products concerned.

Medical device

• Technical file preparation and application submission for a medical device registration/renewal/amendments approval in the Register of Medical Devices managed by the ALIMS, in compliance with the Medical Devices Act.
• Application for conformity assessment of medical device (The registration procedure in the Register of Medical Devices is different for medical devices with and without the CE-mark).
• Preparation of Instruction for Use of a medical device.

Pharmacovigilance

• Pharmacovigilance and vigilance consulting, monitoring and safety reporting to the ALIMS
• Searching through professional and scientific literature published on the territory of the Republic of Serbia.