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NOTICES
Active Substance Master File (Drug Master File) procedure in Medicines and Medical Devices Agency of Serbia
(30.08.2010.)
This DMF procedure can be used in suport of an MAA or MAV, for the active substances, as defined by EMA guideline: EMEA/CVMP/134/02 rev 1, CPMP/QWP/227/02 rev 1 – Guideline on Active Substance Master File procedure.
Medicines and Medical Devices Agency of Serbia should accept Active Substance Master File (ASMF) only if it’s accompanied with the Letter of Access, defined by this EMEA guideline. The DMF holder should give permission to the Medicines and Medical Devices Agency of Serbia to assess the data in the DMF in relation to a specific MAA/MAV, in the form of a “Letter of Access”, Annex 2 of EMA guideline.More...
| Notice of the manner of the request submission and preparation of the documentation for the issuing of the marketing authorization for a medicinal product | |
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Notice of the manner of filing a complaint about the services provided in the Medicinal Products and Medical Devices Agency of Serbia.
We hereby inform you that the current manner of making complaints about the services provided in the Medicinal Products and Medical Devices Agency of Serbia has changed. Please, henceforward submit your complaints to the Administrative Department of the Agency (file room) exclusively in a written form, marked as „ for the QA Manager “. Hereon, your complaints shall be considered and resolved in the manner satisfactory for both parties within the shortest period possible.
Notice regarding the auxiliary medical devices
As to more frequent requests for information in relation to the status of the auxiliary medical devices which were granted market authorization on the basis the of previous Law on production and marketing authorization of medicinal products, we hereby inform you about the following: Article 159, Paragraph 1 of the Law on Medicinal Products and Medical Devices ("The Official Gazette of the Republic of Serbia", number 84/04 and 85/05 ) defines the obligation of the holder of the marketing authorization for the auxiliary medicinal devices to comply with the provisions of the new Law within a two-year period as from the day of the entry in force of this Law. The period expires on August 1, 2006. Namely, the Law on Medicinal Products and Medical Devices defines, among other things, granting marketing authorization for medicinal products, which is more thoroughly defined in the Rules of Procedure and Conditions for Obtaining a Marketing Authorization ("The Official Gazette of the Republic of Serbia", number 93/05), i.e. this Law does not provide for the possibility of marketing authorization for auxiliary medical devices. However, holders of marketing authorization for auxiliary medical devices who select to submit the required documentation for the obtaining a marketing authorization for the current auxiliary medical devices as medicinal products, will have to submit the documentation about their quality, safety and efficiency in compliance with the aforementioned regulations. Therefore, the auxiliary medical devices cannot be marketed as from August 1, of the current year, and it is possible to renew their marketing authorizations, so it is necessary that the holders of their marketing authorizations harmonize with Article 159 of the Law on Medicinal products and Medical Devices. The Medicines and Medical Devices Agency shall particularly notify the Ministry of Health – inspection of medicinal products, to take steps prescribed by the existing Law in the event that there are auxiliary medicinal devices found on market after the set deadline. .
GENERAL REMARKS (MEDICINAL PRODUCTS):
1. When applying for variation the list of submitted documentation which is in compliance with the requirements set forth in A Guideline for the preparation of documentation regarding the variation application – Type Ia and Ib is to be furnished.
A copy of the application for the stated variation in the country, in which it has been approved, should be submitted as well.
2. Besides the prescribed documentation and completed forms for obtaining the marketing authorization, it is necessary for the applicant to provide the Medicines and Medical Devices Agency with a Certificate of the proprietary name of the medicinal product (insofar as the proprietary name is concerned.) issued by the Intellectual Property Institute in Belgrade, 21 Zmaj Jovina str. When filling the pharmaceutical form in requests, 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. In order to conform to the Rules of the content of the market authorization for a medicinal product ("The Official Gazette of the Republic of Serbia", number 93/2005) which prescribes data that must be included in the market authorization, it is necessary, along with the submission of a completed form for the renewal of authorization with respective documentation, to furnish us with the following data:
- Certificate of the proprietary name of the medicinal product (insofar as the proprietary name is concerned) issued by the Intellectual Property Institute in Belgrade, 21 Zmaj Jovina str. Anatomical-Therapeutic-Chemical Classification of a medicinal product (АТC)
- Unique Classification Code of the Medicinal product (UCM)
- The Regime of dispensing a medicinal product, in line with the prescribed classification of medicinal products
- ЕАN identification code
- Description of primary and secundary packaging
4. SUBMISSION OF SmPc AND PIL
After remarks made by the Committee for marketing authorizations regarding medicinal products for human use, final version of the Summary Product Characteristics and Patient Information Leaflet shall be submitted to the Medicines and Medical Devices Agency of Serbia as a completed form which can be found on the Agency ‘s website.
The completed form shall be submitted to the Medicines and Medical Devices Agency of Serbia in an electronic form (a CD or a floppy disk), along with the statement that all the corrections suggested by the Committee for marketing authorizations regarding medicinal products for human use have been made and sent to the e-mail address:
sazeci.uputstva@alims.gov.rs