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SmPC AND PiL

Guidelines on the readability of patient instructions leaflets (PIL) and Summary of product characteristics (SmPC)
Convention to be followed for ЕМЕА-QRD templates
A Guideline on the readability of the label and package leaflet of medicinal products for human use
A Guideline on Summary of Product Characteristics (SmPC)

IMPORTANT

Upon the remarks given by the Committee for marketing authorizations regarding medicinal products for human use, final versions of the Summary of Product Characteristics and Patient Instructions Leaflets are to be submitted to the Medicines and Medical Devices Agency of Serbia as a completed form which can be found on the Agency’s website.

A completed form is to be submitted to the Medicines and Medical Devices Agency of Serbia in the electronic form (a CD or a floppy disk) along with the statement that all the corrections given by the Committee for marketing authorizations regarding medicinal products for human use have been made, and send to the following e-mail address:

sazeci.uputstva@alims.gov.rs

ALiMS - Medicines and Medical Devices Agency of Serbia, Vojvode Stepe 458, 11152 Beograd, Srbija
Phone. +381 11 3951 139, +381 11 3951 104 Fax. +381 11 3951 131, Phone./Fax. +381 11 3951 147
Web site: www.alims.gov.rs, E-mail: hygia@alims.gov.rs Web Master: tatjana.stojadinovic@alims.gov.rs

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