Services
1 Consulting services related to the marketing authorization issues (only once for one medicinal product)
2 Preparing a request for providing scientific advice to the competent authority
3 Management of marketing authorization process according to the requirements of the EAEU in the Russian Federation (reference Member State or concerned Member State concerned)
4 Bringing the marketing authorization application dossier in accordance with the requirements of the EAEU in the Russian Federation (reference Member State or concerned Member State)
5 Variations to the marketing authorization application dossier of the medicinal product authorized pursuant to the EAEU requirements, including:
• Administrative changes and variations not related to Quality changes and/or Safety, Efficacy and Pharmacovigilance changes
• Variations that require assessment of documents on Quality and/or Safety, Efficacy and Pharmacovigilance
• Adding a new indication for use or modifying an existing one, significant modifications of the Summary of Product Characteristics
• Replacing or adding a new manufacturing site for some of or all manufacturing processes
• Extension of marketing authorization
6 Inclusion of API manufactured for the purposes of distribution in the State Register of Medicines in accordance with Federal Law No. 61-ФЗ of April 12, 2010 “On Circulation of Medicines”
7 Confirmation (renewal) of the marketing authorization of a medicinal product in accordance with Federal Law No. 61- ФЗ dated April 12, 2010 “On Circulation of Medicines” and EAEU requirements
8 Variations to marketing authorization documents in accordance with Federal Law No. 61-ФЗ of April 12, 2010 “On Circulation of Medicines.” These include:
• variations that require no assessment
• variations that require assessment
• adding indications to the prescribing information
• changing manufacturing sites
1 Support in obtaining a clinical trial authorization, including preparation of a set of documents (Study Protocol, Investigator Brochure, Patient Information)
2 Assistance in therapeutic equivalence studies
3 Assistance in bioequivalence studies
4 Preparation of clinical study reports for therapeutic equivalence studies
5 Preparation of clinical study reports for bioequivalence studies
6 Preparation of clinical overview
7 Preparation of non-clinical overview
8 Making arrangements for GLP-consistent non-clinical studies
9 Making arrangements for comparative dissolution study (1 dosage/1 batch)
10 Making arrangements for user-acceptance testing of instructions for medical use (Package Insert)
11 Toxicological assessment of a medicinal product (PDE calculation)
1 Preparation and approval of draft normative documentation
2 Quality control of medicinal product samples
3 Preparation of Quality Overall Summary
1 State registration and re-registration of manufacturer’s maximum retail prices for medicinal products included in the Vital and Essential Drugs List:
• State registration of a price of a Vital/Essential Drug
• Re-registration of a price of a Vital/Essential Drug
• Amendments to the registry entry of the price of a Vital/Essential Drug
• Consulting services (only once for one medicinal product)
1 Assistance in obtaining GMP Certificate (consulting services, initial document review, preparation of the Master File (Dossier) and its submission to the Ministry of Industry and Trade of the Russian Federation, preparation and submission of responses to the request from the Ministry of Industry and Trade of the Russian Federation)
2 Assistance in obtaining GMP Certificate (consulting services, initial document review, compilation of a set of documents and its submission to the Ministry of Industry and Trade of the Russian Federation, control and maintenance of the set of documents, submission of additional materials, responses to the Request to the Ministry of Industry and Trade of the Russian Federation and Federal State-Funded Institution “State Institute of Drugs and Good Practices”)
3 Assistance in obtaining Drug Manufacturing License (consulting services, initial document review, providing an opinion regarding completeness of the provided set of documents, compilation of the set of documents and its submission to the Ministry of Industry and Trade of the Russian Federation, control and maintenance of the set of documents, submission of additional materials to the Ministry of Industry and Trade of the Russian Federation)
4 Assistance in obtaining Drug Manufacturing License (initial document review, providing an opinion regarding completeness of the provided set of documents, refinement of the required documents, compilation of the set of documents and its submission to the Ministry of Industry and Trade of the Russian Federation, control and maintenance of the set of documents, submission of additional materials to the Ministry of Industry and Trade of the Russian Federation, visits to the manufacturing site to control its preparation for licensing)
5 Drug Manufacturing License renewal (consulting services, initial document review, providing an opinion regarding completeness of the provided set of documents, compilation of the set of documents and its submission to the Ministry of Industry and Trade of the Russian Federation, control and maintenance of the set of documents, submission of additional materials to the Ministry of Industry and Trade of the Russian Federation)
6 Assessment of the corrective and preventive action plan (CAPA)
7 Investigation of the root causes of possible critical and significant GMP non-compliances, САРА preparation
8 Preliminary audit of the manufacturing site for compliance with licensing requirements, requirements of Good Manufacturing Practice (for Russian manufacturers). Detection of GMP non-compliance and identification of regulatory risks. Providing recommendations regarding elimination of identified non-compliances
9 Preliminary audit of the manufacturing site for GMP compliance (for foreign manufacturers) Detection of GMP non-compliance and identification of regulatory risks. Providing recommendations regarding elimination of identified non-compliances
10 Consulting services in implementation of the GMP requirements
11 Support for receiving a document on the stages of the manufacturing process of a medicinal product for human use carried out in the territory of the Eurasian Economic Union (initial review, Dossier compilation and submission to the Ministry of Industry and Trade of the Russian Federation)
12 Conducting advanced GMP training, expert and consulting workshops on various GMP subjects
1 Making arrangements for obtaining an import permit for import of a specific batch of approved and/or unapproved medicinal products to the Russian Federation issued by the authorized federal executive body, not including preparation of the justification on the quantity required for import
2 Making arrangements for obtaining an import permit for import of a specific batch of approved and/or unapproved medicinal products to the Russian Federation issued by the authorized federal executive body, including preparation of the justification on the quantity required for import