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Forms - medicinal product
Guidelines for obtaining the marketing authorization for a medicinal product| A Guideline for form filling |  |
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| Notice on the manner of submission of the application and preparation of documentation for granting the marketing authorization for a medicinal product | |
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| A Guideline for the preparation of documentation regarding the variation application – Type Ia and Ib | |
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During the variation application the list of the submitted documentation in compliance with the requirements set forht in the Guideline is to be submitted. A copy of the application for the stated variation in the country in whih it has been approved is to be submitted as well.
Forms regarding obtaining the marketing authorization for a medicinal product
| Application for obtaining the marketing authorization for a medicinal product ("The Official Gazette of the Republic of Serbia" 93/2005) | |
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IMPORTANT !
Besides prescribed documentation and completed forms for obtaining the marketing authorization for a medicinal product, it is necessary that an applicant submits to the Medicines and Medical Devices Agency, a Certificate issued by the Intellectual Property Office, Belgrade, 21 Zmaj jovina Str., regarding the proprietary name of a medicinal product, insofar as the proprietary name is concerned. When filling in a pharmaceitical form in applications, it is neccessary to use the standard terms for the pharmaceutical forms which can be found on the Agency’s website in the functional unit Pharmacopeia Pharmacopoeia/Standard terms.
| Variation application – variation application for the already approved documentation ("The Official Gazette of the Republic of Serbia" 93/2005) | |
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| Application for the variation of the authorization - change to the authorization – transfer of the marketing authorization for a medicinal prodcut ("The Official Gazette of the Republic of Serbia" 93/2005) | |
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| Application for the renewal of the maraketing authorization ("The Official Gazette of the Republic of Serbia" 93/2005) | |
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IMPORTANT!
For the purpose of reconciliation with the Rules of the contents of the marketing authorization for a medicinal product ("The Official Gazette of the Republic of Serbia" 93/2005) prescribing the data which the marketing authorization for a medicinal product must contain, along with the completed form for the renewal of the marketing authorization with the relevant documentation, it is neccessary to submit the following data:
- Certificate issued by the Intellectual Property Office, Belgrade, 21 Zmaj jovina Str., regarding the proprietary name of a 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
Forms regarding clinical trials
| Application for the authorization of clinical trials/clinical trial application | |
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| Application for the authorization of variations of and amendments to clinical trials | |
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| Notice on the completion of clinical trials | |
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| Authorizatiom for the import of medicinal products for use in clinical trials | |
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Forms regarding the adverse reactions of a medicinal products
| Application of the adverse reactions of a medicinal product | |
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Forms regarding the application of false medicinal products
| Application of false medicinal products | |
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