
How to register new dosage form for the approved drug?
With the entry into force of the EAEU Medicines Registration Rules, applicants have the opportunity to follow more flexible regulatory procedures and, for example, add a new dosage form within the framework of an existing registration. In this article, we will look at how you can avoid new registration if you plan to introduce a new dosage form of an already approved drug to the market.
- Case
Currently, many marketing authorization holders are planning a procedure for bringing dossiers for drugs into compliance with the requirements of the EAEU. It often happens that during the existence of a drug on the market, companies develop new dosage forms, the dossiers of which are at least 50% identical to the dossier of the approved drug, and therefore it would be logical to register the dossier of a new dosage form based on an already registered drug. This became possible with the introduction of the so-called “extension of registration” procedure, which can be completed after bringing the dossier into compliance with the requirements of the Union.
- Procedure
The procedure for extension of registration is described in Decision 78 “On the Rules for Registration and Examination of Medicines for Medical Use” and formally refers to the variation.
The extension of registration applies to certain changes in the active pharmaceutical ingredient (API) and to certain changes in the drug product (changes in dosage, dosage form and route of administration).
To initiate the registration extension procedure, the following documents will be required:
- cover letter;
- application for amendments;
- supporting data regarding the proposed registration extension;
- complete module 1 of the registration dossier with justification for the absence of data or documents included in the relevant sections of module 1;
- appropriate update or attachment to quality summaries, non-clinical and clinical reviews. If preclinical or clinical study reports (even just one) are submitted, a summary must be included in Module 2;
- if the extension affects the summary of product characteristics - labeling or package information leaflet, as well as a quality regulatory document: revised information about the medicinal product, a quality regulatory document should be presented in the appropriate format.
Despite the fact that the type of this procedure relates to variations, the duration of the examination is 140 days (4.5 months).
- Advantages
The undoubted advantage of registering a new dosage form on the basis of the “parent dossier” is the reduced amount of paperwork. In addition, due to the fact that the extension of registration relates to the variation procedure, the fee will be 150 thousand rubles instead of 325 thousand rubles.
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