he company itself must decide when an application for inspection of a production site should be formed.

At the same time, it is necessary to consider:

1. The time-line consideration of an application by the Ministry is 30 working days (if the file was compiled correctly and qualitatively).
2. 160 working days are allocated for an inspection, counting from the date of a decision made by the authorized body to conduct the inspection.
3. The enterprise should develop and successfully implement a pharmaceutical quality system that includes compliance with the requirements of the Rules of Good Manufacturing Practice.
4. In the company must work qualified personnel, it must have the proper facilities, equipment and technical means.

1. If a medicine is in the process of registration, the applicant must submit those documents that have been filed within the registration dossier.
2. If a medicine is in the process of preparing for registration, then it is premature to file an application for inspection.

Decree of the Government of the Russian Federation of December 3, 2015 № 1314 «On determining the compliance of medicines manufacturers with the requirements of the rules of Good Manufacturing Practice» (together with the «Rules for organizing and conducting inspection …»).

1. Inspection should be carried out within a period not exceeding 160 working days from the date of the decision by the Ministry of Industry and Trade of Russia to conduct an inspection. The duration of an inspection may not exceed 10 working days, excluding travel time to an inspection site.
2. The authorized institution shall, within 20 working days from the date of receipt of an application and documents from the authorized body, enter the foreign manufacturer in the inspection schedule (hereinafter referred to as the schedule), which isconfirmed by the authorized body.
3. Information about the schedule and the changes made to it is being posted on the official web-sites of the authorized body and authorized institution on the Internet within 3 working days from the date of its preparation or changes to it.

Registered – yes.

In the process of registration:

1. RD is ready, but not submitted to the MOH – yes.
2. RD is not ready, not submitted to the MOH – no.
3. Undergoing preclinical/clinical studies etc. – yes.

1. Information about the schedule and the changes made to it is posted on the official web-sites of the authorized body and authorized institution on the Internet within 3 business days from the date of its preparation or changes to it.
2. The authorized institution within 3 business days from the date of approval of the schedule notifies a foreign manufacturer or its authorized representative on the timing of an inspection and the need to conclude an agreement defining the inspection procedure and the associated costs, rights and obligations of the inspectors and the foreign manufacturer (hereinafter – the agreement), as well as the need to pay within 20 business days from the date of the agreement expenses related to the inspection by an authorized institution in the amount determined by the agreement, but not exceeding the maximum amount of inspection fees approved by the authorized body, calculated on the basis of the methodology approved by the authorized body.