Alims ALiMS Vlada Republike Srbije
ALiMS
NOTICES

GENERAL NOTICES (MEDICINAL PRODUCTS):

1. 1. At the variation application the list of submitted documentation in line with the requirements set forth in A Guideline for the preparation of documentation regarding the variation application – Type Ia and Ib.
A copy of the mentioned variation application from the country in which it has been approved is to be submitted.

2. Along with the prescribed documentation and completed forms, it is neccesary that the applicant submits to the Medicines and Medical Devices Agency a Certificate issued by the Intellectual Property Institute in Belgrade, 21 Zmaj Jovina str. on the the proprietary name of the medicinal product (insofar as the proprietary name is concerned). When filling in pharmaceutical form in applications, it is necessary to use standard terms for pharmaceutical forms which can be found in the functional unit Pharmacopoeia/Standard terms on the Agency’s website.

3. For the purpose of harmonization with the Rules on the contents of a marketing authorization for medicinal products (“The Official Gazette of the Republic of Serbia” no. 93/2005) prescribing data a marketing authorization should contain, it is necessary that the completed form for authorization renewal with appropriate documentation is accompanied by the following data:

  • Certificate issued by the Intellectual Property Institute in Belgrade, 21 Zmaj Jovina str. on the the proprietary name of the medicinal product (insofar as the proprietary name is concerned).
  • Anatomical – Therapeutic – Chemical classification code for medicinal product (ATC)
  • Unique Classification Code of a medicinal product (UCM)
  • Regime of dispensing a medicinal product, in line with the prescribed classification of a medicinal product
  • ЕАN identification code
  • Description of primary and secondary packaging
4. SUBMITTING SmPC AND PIL

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 disc) 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