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NEWS |
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June 2011. The Rule Book on the content and labeling of medicinal products outer and inner packing, additional labeling and information leaflet
The Rule Book on the content and labeling of medicinal products outer and inner packing, additional labeling and information leaflet was published on 10 June 2011 (Off. Gazette RS No. 41).
The Rule Book stipulates requirements regarding labeling and content of outer packing, inner packing, patient information leaflet and information leaflet for a veterinary medicine.
Some news introduced by this Rule Book are related to:
- change of the requirement regarding the presenting the name of a human medicine in Braille
- additional labeling
- the way of presenting names of excipients
- the content of data on supplementary sticker
- documentation necessary for request for control sticker.
Marketing authorization holder should harmonize the process of affixing the control sticker on outer packing with corresponding provisions of this Rule Book at the latest until 01 January 2012. Batches which are produced before this date and which are on the market, do not need to be labeled by control sticker.
For complete information please contact Nevena Obradovic by phone +381 11 347 12 03 or by
E-mail: nevena@polifarm.com
April 2011. The Rule book on changes and addendums to the Rule Book on dietary products health safety
The Rule book on changes and addendums to the Rule Book on dietary products health safety was published on 20 April 2011 (Off. Gazette RS No. 27).
This Rule Book introduces minor changes, of which some are the changes regarding the documentation that is necessary to be submitted during the procedure of entry in the database maintained by the competent Ministry.
Rule Book on dietary products health safety is published on 3 July 2010 in the Official Gazette of RS No. 45.
This Rule Book introduces the obligation of applying for dietary product entry in the database maintained by the competent Ministry.
In addition to other required data, Declaration of dietary product includes the number and date of the registration in database of the Ministry.
The Rule Book does not define a transitional period during which the importers and manufacturers can harmonize with the stipulations of the Rule Book.
For complete information please contact Velimir Djelic by phone +381 11 288 50 38 or by
E-mail: daca@polifarm.com
April 2011. The Rule book on criteria, way and procedure for placing or deleting medicines on/from the List of medicines that are prescribed and dispensed under the mandatory health insurance
The Rule book on criteria, way and procedure for placing or deleting medicines on/from the List of medicines that are prescribed and dispensed under the mandatory health insurance was published on 12 April 2011 (Off. Gazette RS No. 25).
This Rule Book, among other things, stipulates documentation that is necessary for Request for placing medicines on the List of medicines (Reimbursement List).
For complete information please contact Velimir Djelic by phone +381 11 288 50 38 or by
E-mail: daca@polifarm.com
October 2010. The Rule Book on the procedure of medicinal products and medical devices advertising
Rule Book on the manner of medicinal products and medical devices advertising was published on 29 October 2010. (Off. Gazette RS No. 79.)
The Rule Book describes closer what advertising of medicinal products and medical devices includes, regulates the content of advertising messages and promotional materials, and defines the obligation of keeping data on promotional materials and activities and their availability to the public or relevant Ministry.
The Rule Book does not define the terms in which ALIMS approves promotional materials and other documentation relating to the advertising of medicinal products.
For complete information please contact Nevena Obradovic by phone +381 11 347 12 03 or by
E-mail: nevena@polifarm.com
August 2010. The Rule Book on the procedure of registration of medical devices in the Register of Medical Devices
The Rule Book on the procedure of registration of medical devices in the Register of Medical Devices and content on requirements for the registration of medical devices in the Register of medical devices was published on 13 August 2010 (Off. Gazette RS No. 57).
This Rule Book clearly defines the method of registration, registration renewal and amendment/addition of registration of medical devices in the Register of medical devices, as well as the condition to be met by the applicant.
One of the novelties introduced by this Rule Book is simplified and shortened procedure for registration CE marked medical devices in Register of medical devices (mainly administrative documentation is required, and the procedure takes 90 days instead of 240 days).
For medical devices that do not have the CE mark, besides administrative documents, it is necessary to submit documentation on quality, safety and efficiency, and the procedure takes 240 days.
For complete information please contact Irena Maric by phone +381 11 288 52 79 or by
E-mail: irena@polifarm.com
May 2010. The Law on Medicines and Medical Devices
The Law on Medicines and Medical Devices has entered into force on May 2010 (Official Gazette RS, No. 30/2010).
Some of the changes made by the new law are:
- Method of price regulation for OTC products (free price formation is allowed).
- Changes in procedures and documentation for registration of medical devices.
- Introduction of the obligation for submitting promotional materials and other documents
relating to advertising of medicines to Medicines and Medical Devices Agency for approval.
-The introduction of the so-called sunset clause – Marketing Authorization ceases to be valid if
the medicine was not on the market in the Republic of Serbia for three years from the date of
issuance of Marketing Authorization, or if the medicine was on the market in the Republic of
Serbia for some period of time after the issuance of Marketing Authorization, but after that
period was not on the market for consecutive three years.
-The introduction of obligations to inform Medicines and Medical Devices Agency on registered
medicine launching to the market, as well as the cessation of medicine selling (supply of the
market).
- Defining the terms in which Medicines and Medical Devices Agency issues Certificates of
analysis for medicines.
- Introduction of the obligation of labelling the outer packaging in Braille.
- Shortening the procedure for obtaining Marketing Authorization for medicines that are
registered by Centralized Procedure (150 days).
- Change of the terms for amending Marketing Authorization and similar.
For further information, assistance or explanation, please contact: office@polifarm.com
Regulatory Affairs Services Registration of medical devices Drug registration. Serbia Drug Registration OTC registration. Serbia Srbija Medical devices registration. Serbia Srbija Regulatory Affairs Serbia Drug Registration The Agency Medical Devices Registration Regulatory References Drugs Medical Devices Serbia Srbija Pharmacy Consulting Pharmacy Serbia Regulatorni poslovi Srbija Agencija za Lekove i medicinska sredstva Registracija lekova u Srbiji Regulativa reference Lekovi registracija Medicinska sredstva registracija konsalting farmacija Srbija Agencija lekovi registracija Registration of OTC products
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