Documents to be provided for registration/renewal of medicines
Pact 1. Administrative documents
* Providing GMP Certificate along with copy of reports of last inspection is mandatory only for foreign manufacturers.
NOTE.
In case if in manufacturing process take part more than 1 manufacturer, points 1.3.2. and 1.3.4. is to be provided for all parts of manufacturing process.
Part.2. Chemical, Pharmaceutical and biological information about medicines, which contain chemically and/or biologically active ingredients
2.2.S. Active ingredient(s) (fore medicines, which contain more than one active ingredients, information is to be provided for each active ingredient)
2.2.S.1. General information:
2.2.S.1.1. Name
2.2.S.1.2. Structure
2.2.S.1.3. General properties
2.2.S.2. Manufacturing of active ingredient
2.2.S.2.1. Information about manufacturer
2.2.S.2.2. Description of manufacturing process and in-process control
2.2.S.2.3. Control of raw material, used in technological process
2.2.S.2.4. Control of critical steps and intermediate products
2.2.S.2.5. Process validation and/or its evaluation
2.2.S.2.6. Manufacturing process development
2.2.S.3. Active ingredient characteristics
2.2.S.3.1. Elucidation of Structure and other Characteristics
2.2.S.3.2. Impurities
2.2.S.4. Control of active ingredient(s)
2.2.S.4.1. Specification
2.2.S.4.2. Analytical procedures
2.2.S.4.3. Analytical method validation
2.2.S.4.4. Batch Analyses
2.2.S.4.5. Justification of Specification
2.2.S.5. Reference Standards of Materials
2.2.S.6. Container Closure System
2.2.S.7.Stability
2.2.S.7.1. Stability Summary and Conclusions
2.2.S.7.2. Post-Approval Stability and Stability Commitment
2.2.S.7.3.Stability Data
2.2.P. Drug Product
2.2.P.1. Description and composition of drug product
2.2.P.2. Pharmaceutical development
2.2.P.2.1. Components of the Drug Product
2.2.P.2.1.1. Drug substance
2.2.P.2.1.2. Excipients
2.2.P.2.2.Drug Product
2.2.P.2.2.1.Formulation Development
2.2.P.2.2.2.Overages
2.2.P.2.2.3.Physicochemical and Biological Properties
2.2.P.2.3. Manufacturing Process Development
2.2.P.2.4. Container Closure System
2.2.P.2.5. Microbiological Attributes
2.2.P.2.6. Compatibility
2.2.P.3. Manufacturing
2.2.P.3.1. Manufacturer
2.2.P.3.2. Batch-formula
2.2.P.3.3. Description of manufacturing process and in-process control
2.2.P.3.4. Control of critical steps and intermediate products
2.2.P.3.5. Process validation and/or its evaluation
2.2.P.4. Control of Excipients
2.2.P.4.1. Specification(s)
2.2.P.4.2. Analytical procedures
2.2.P.4.3. Analytical methods validation
2.2.P.4.4. Justification of Specification
2.2.P.4.5. Excipients of human or animal source
2.2.P.4.6. Novel Excipients
2.2.P.5. Controlof Drug Product
2.2.P.5.1. Specification(s)
2.2.P.5.2. Analytical Procedures
2.2.P.5.3. Analytical method validations
2.2.P.5.4. Batch analysis
2.2.P.5.5. Impuritiescharacteristics
2.2.P.5.6. Justification of Specification
2.2.P.6. Reference standards and substances
2.2.P.7. Container Closure System
2.2.P.8. Stability
2.2.P.8.1. Stability Summary and Conclusions
2.2.P.8.2. Post-Approval Stability and Stability Commitment
2.2.P.8.3. Stability Data
2.2.A. Appendices
2.2.A.1. FacilitiesandEquipment
2.2.A.2. Adventitious agents and safety evaluation
2.2.A.3. Novel Excipients
2.2.R. Regional information
2.3.Literature references
Part.3. Pre-clinical studies reports
3.1. Content
3.2. Study Reports
3.2.1. Pharmacology
3.2.1.1. Pharmacodynamics
3.2.2. Pharmacokinetics
3.2.3. Toxicology
3.2.3.1. Single-dose toxicity
3.2.3.2. Repeat-dose toxicity
3.2.3.3. Genotoxicity
3.2.3.4. Carcinogenicity (long-time studies; short-time and middle-time studies)
3.2.3.5. Reproductive and ontogenetic toxicity: gonadotoxicity, embriotoxicity, teratogenic action
3.2.3.6. Local Tolerance (local irritative effect,allergenic action)
3.2.3.7. Other toxicity studies: Antigenicity, immunotoxicity, others
3.3. Literature references
Part.4. Pre-clinical studies reports
4.1. Table of content
4.2. Clinical study reports
4.3. Reports of Biopharmaceutics Studies
4.3.1. Reports of Biopharmaceutics Studies
4.3.2. Reports of Studies Pertinent to Pharmacokinetics using Human Biomaterials
4.3.3. Reports of human pharmacokinetic (PK) studies
4.3.4. Reports of human pharmacodynamic (PD) studies
4.3.5. Reports of efficacy and safety studies
4.3.6. Reports of post-marketing experience
4.3.7. Case report forms and individual patient listings, when submitted
4.4. Literature references
NOTES.
Documents, provided in the list, are required based on source, properties, pharmaceutical form and manufacturing specificity.
In case if separate parts are not provided in correspondent part – please provide reasonable justification.
For registration of active substances (raw materials) following documents to be provided: 1.1-1.3.4, 1.4.4., 1.5., 1.7., 2.1.-2.2.S.7.3.
If Certificate of Conformity to European Pharmacopoeia (CEP) documents mentioned in points 2.2.S.2.-2.2.S.3.2.and 2.2.S.7.-2.2.S.7.3, are not required. Validity of CEP certificate is checked by responsible person in electronic database of European Directorate of medicines quality and public health service.
Application for prolongation of registration certificate validity must contain data mentioned in 1st and 2nd parts.
Application for registration certificate of GENERIC medicines must contain data mentioned in 1st and 2nd parts, along with data, demonstrating bioavailability and bioequivalence with original brand product, in condition if it is not biological medicine.
