Contents of the Registration Dossier
* The documents covered by items 10-13 and 17 must be provided in case of the State Registration of original medicinal products or generic ones, which are allowed for medical use in the territory of the Russian Federation for less than 20 years.
** The document covered by item 14 must be provided in case of the State Registration of medicinal products, which are allowed for medical use in the territory of the Russian Federation for more than 20 years, when it is impossible to perform a bioequivalence study.
*** The document covered by item 18 must be provided in case of Confirmation of the State Registration of a medicinal product (in case of expiration of the Marketing Authorization validity).
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1
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Draft labels of primary and secondary packaging.
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2
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A document issued by the corresponding authorized agency and translated into Russian, which confirms that the manufacturer of the medicinal product follows GMP (Good Manufacturing Practice).
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3
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Original text of Pharmaceutical Norms and Regulations from the manufacturer of the medicinal product or a reference to the corresponding Pharmacopoeial Monograph.
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4
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Description of Manufacturing Process and Process Controls, Process Flow Chart, Batch Formula, Process controls, Control of critical steps and intermediates, Equipment qualification, Validation of the manufacturing process (Validation protocol, report).
(These documents must be provided both for medicinal products and the APIs).
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5
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A document, issued by the corresponding authorized agency and translated into Russian, which confirms the API manufacturer's following GMP (Good Manufacturing Practice).
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5 a/a
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International Nonproprietary Name for the API or its both chemical and trade names. An extract from the official Monographs (Eur. Ph or USP or BP) containing the description of the API and its properties.
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5 б/b
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The name and address of the API manufacturer.
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5 в/c
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API shelf life.
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6
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A document, confirming quality of the API used in the manufacture of medicinal products.
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7
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Original text of Pharmaceutical Norms and Regulations from the API manufacturer of the medicinal product or a reference to the corresponding Pharmacopoeial Monograph.
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8
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Recommendations on storage and transportation of the medicinal product (Tables of stability with stability test results of the medicinal product confirming its shelf-life period in the proposed primary package form, Stability report).
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9
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Pre-clinical studies report, containing description, results and statistical analysis of these pre-clinical studies results.
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10*
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CT Protocol
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11*
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Investigator's brochure
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12*
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Patient Information Sheet
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13*
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Information about payments and amends to the patients (healthy volunteers, afflicted persons), who are involved in the clinical studies of the medicinal product, bioequivalence studies and (or) therapeutic equivalence.
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14**
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International multicenter clinical studies report provided that a part of these studies were carried out in the territory of the Russian Federation.
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15
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SPC (Summery of Product Characteristics), BPI (Basic Prescribing Information).
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16
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A copy of the document issued by the corresponding authorized agency and translated into Russian, which confirms the registration (approval) of the medicinal product, if it is registered out of the Russian Federation.
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17
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Documents, provided in accordance with Articles 19 - 23 of Federal Act of RF № 61-FA "Of Drug Circulation" d/d April 12, 2010
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18***
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PSUR, made by the Applicant according to the form specified by the corresponding authorized federal body of the executive branch - Ministry of Health and Social Development of the Russian Federation (Minzdravsocrazvitiya Rossii).
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