Prices

Service	Term (months)9	Raifarm service fee (Euro.) 1
		Min.	Max.
Fixed service fees (milestones based) 2
Drug registration in Russia as the Referent State of EAEU 3 4	15–18 10	50,000	80,000
The consequent recognition of the drug in one of the Confirmation State of EAEU	6–10	5,000	12,000
National RB or RK dossier alignment with EAEU requirements and the following geography extension to Russia	10–12	35,000	45,000
National RF dossier alignment with EAEU requirements	10–12	25,000	40,000
Readability test of patient information leaflet	2–3	7,000	12,000
CMC variation with expert evaluation requiring laboratory examination	3–15 11	12,000	20,000
CMC variation with expert evaluation not requiring laboratory examination	3–15 11	3,000	10,000
Variation requiring evaluation of safety-efficacy ratio	3–15 11	7,000	12,000
Administrative variation not requiring expert evaluation	3–15 11	2,000	4,000
Gap analysis of the registration dossier to assess strategy of registration in EAEU		3,000	5,000
GMP inspection by RF competent authorities 5
Consulting and technical support in organization and conduction of a GMP inspection	8–10 12	15,000	20,000
Mock audit prior to a GMP inspection	3–4	15,000	20,000
Price registration
Registration or renewal of the maximum selling price for a drug included into the Essential Drug List of RF 6		3,000	9,000
Registration of medical devices (MD) 7
Registration of MD via the national RF procedure	10–18	12,000	20,000
Registration of MD via the EAEU procedure	12–18	15,000	25,000
Administrative variation not requiring laboratory/clinical tests		1,500	5,000
Variation requiring laboratory/clinical tests		10,000	20,000
Gap analysis of an MD dossier to assess strategy of registration		1,500	2,500
Hourly rate-based service (cost per working hour)
Local QPPV function for drug products		120	120
Local authorized representative function for MDs		100	100
Ad hoc consulting not related to concrete projects		200	200
Registration projects related services, if not rendered on the fixed cost basis 8		75	150
Ad hoc consulting for drug products		200	200
Ad hoc consulting for MDs		150	150
Translation of documentation (cost per page)
English to Russian		10	10
Russian to English		12	12
Non-English to Russian		12	12
Notarization of translations		3	3

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¹ Service fee may vary from min to max and will be agreed upon acceptance of Raifarm offer for a concrete case.

² Service fee does not include documentation translations, official filing fees, expenses related to importation pf samples for laboratory examination.

³ EAEU – Eurasian Economic Union, which includes five countries: Russian Federation (RF), Republic of Belarus (RB), Republic of Kazakhstan (RK), Armenia and Kyrgyzstan.

⁴ If a product needs a pre-registration clinical study in EAEU Raifarm will recommend a local CRO. The indicated Service fee does not include clinical study costs.

⁵ Service fee does not include documentation translations, charges of the Federal Budget Organization “State Instituted of Drugs” and travel expenses (if they are required).

⁶ Service fee depends on reasons for price registration (new registration, annual renewal, renewal due to other reasons) and the numer of SKU.

⁷ Service fee does not include documentation translations, official filing fees, expenses related to importation pf samples for technical, toxic and clinical tests, services of laboratories and clinics, costs of QMS inspection (if it is required).

⁸ Service fee depends on the professional qualification of the Raifarm staff.

⁹ The specified period assumes the timely provision by the customer of documentation, as well as, if applicable, samples for pharmaceutical examination (drugs) or testing (medical devices).

¹⁰ The specified period does not include the conduction of a local clinical trial (if required).

¹¹ The specified period depends on the complexity of the variation.

¹² The specified period assumes the consent of the manufacturing site to accept the inspection on the dates proposed by the inspectors.