Samples importation (for registration purposes) Prepared by Irina Ulianova February 2017 www.oootranslit.ru

Two approaches for importation There are 2 approaches: To import all necessary for quality expertise products based on internal calculations. + time saving (importation is planned before the expertise start) - 1) the quantity of products/form of RS can differ significantly from the experts’ calculations 2) the stock of samples 3) expenses 2) To wait until official calculations made by the experts and organize samples importation. In this case the very important point is good project management. + you are within budget, no stock - the timeline for importation is very tight Important EP CRS, USP RS, Sigma and other standards and chemicals; chromatograph columns better to purchase from local distributors because of custom reasons www.oootranslit.ru

Comparison of importation schemes First approach scheme ND/Variation preparation (made by Service Provider). Calculation of necessary quantities for 3 analysis and confirmation with the manufacturer (made by Service Provider). Purchase order for samples of products, in-house reference standard (to the manufacturer’/MAH’s name) (made by Service Provider). Order for pharmacopoeial standards or Sigma (etc) chemicals to local distributors. (made by Service Provider). Shipment of samples (made by Manufacturer/MAH) Submission of the dossier (made by Service Provider) Custom clearance of API/FDF samples, information sharing with the manufacturer/MAH (made by Service Provider). Submission samples to the Expert Organization (made by Service Provider) Second approach scheme ND/Variation preparation (made by Service Provider). Submission of the dossier, receipt of calculation of needed products to the quality expertise (made by Service Provider). Purchase order for samples of products, in-house reference standard (to the manufacturer’/MAH’s name) (made by Service Provider). Order for pharmacopoeial standards or Sigma (etc) chemicals to local distributors. (made by Service Provider). Shipment of samples (made by Manufacturer/MAH) Custom clearance of API/FDF samples, information sharing with the manufacturer/MAH (made by Service Provider). Submission samples to the Expert Organization (made by Service Provider) www.oootranslit.ru

Documents needed for importation 1st stage. Obtaining of Importation permission: made by Service Provider. This document is to be received within several weeks (3-4 in average) since submission of following documents: 1) application form (name of API, manufacturer, quantity, country of origin) 2) COA 3) ND 4) POA 5) Proforma invoice (optionally) 6) Official document of applicant (Service Provider) Proforma Invoice. This document is to contain: Name, address, contact details of the Sender and Receiver. The name of the Sender is to be equal to the Company name mentioned into the Import permission Terms of delivery as CPT Name of product, quantity, packaging (in details!!! Primary, secondary packaging), weight (net, gross), price (up to 100$), currency Statement about non-commercial usage or “for registration issues” Storage conditions Statement about dangerousity of the Good Destination – SVO CARGO Quantity is to be equal to the same stated into the import permission* (in case of choice the 2nd approach scheme) MSDS (optionally for drugs, mandatory for in-house standards and APIs) Certificates of analysis (COAs) www.oootranslit.ru

Green light for shipment Importation scheme In case of usage the courier Company (DHL, etc), please insist that the destination is to be SVO CARGO! Usually courier companies work with SVO MOSCOW and due to the long queues, bad attitude to the small volume goods and other features, it is very difficult to make the custom clearance Preparation and obtaining of Import permission (IP) Confirmation of COA, Proforma-invoice (PI), avia transporter Company, there are to be: Aeroflot SAS KLM Air France Alitalia Air China or EMS in some cases Package is prepared (PI, COA, IP, MSDS, samples in good condition and protected package) Green light for shipment Custom clearance Submission to the Expert State Institute for quality control www.oootranslit.ru

F.A.Q. How to import in-house standards? We include it in the application form, add the COA and receive the letter from the MOH saying that this material is not API but only chemicals and MOH does not provide official import permission. This letter is to be included into the package and will be shown at the custom clearance. How to deal with placebo shipment? It is shipped together with the products following one import permission. It is needed to put inside package the ND with a Composition data. We will issue the explanation letter about placebo in case it will be required. How long takes custom clearance? Everything depends on careful document checking beforehand, good labelling, danger level of the Good and transporting conditions. Usual period is from 1 to 3 weeks. What basis of delivery is preferable? We ask to use CIP, CPT if possible Can we send samples directly to the State Organization (FGBU)? Unfortunately not. The FGBU provide applicants with exact date and time to submit samples with all related letters and other documents. They do not make the custom clearance; communication is only on Russian language. Can you store our Good at your facilities? Usual period of storage not to exceed 2 months. In case we have a stock and our clients ask to share it with local Companies there is no problem. www.oootranslit.ru