API registration procedure and timeline

Stages

Pharegis activities

Typical duration by Pharegis

1

Gap analysis and review of CMC (chemical, analytical, manufacturing) and administrative dossier parts,

3-5 business days

2

Considering the dossier updates with Customer,

receipt of additional and adjusted dossier parts

5-10 business days (depends on:

 customer procedures)

3

·   Local notary legalization of required administrative documents.

·   Preparation of the ND draft;

·   Translation of all dossier parts to Russian (required);

·   Preparation of the application (physical and electronic);

·   Providing calculation for required quantities of samples and reference standards for the official QC expertise;

·   Paying state duty to MoH.

10-20 business days

(depends on:

 API type, dossier complexity)

4

·   Submission of the API registration dossier to Russian MoH;

·   Submission for official permissions for import of the samples and reference standards;

·   Receipt of official MoH permission letters for import of the samples and reference standards.

5-7 business days

5

·   Initial dossier review by MoH; MoH decision for the expertise

·   Import and customs clearance of the samples and reference standards

·   Submission of the samples and reference standards to FSBI SCEEMP for the official QC expertise

15-30 business days (depends on:

MoH, shipment readiness,

queue of applicants)

5

Receipt of the official expertise request

20-55 business days

(depends on the expertise)

6

Official addressing the official expertise request

10-20 business days

(depends on customer)

7

Obtaining API registration

15-25 days

(depends on:

MoH)