Russia: Revised procedure for compiling a dossier for a pharmaceutical

As of 20 August 2017, all organisations that apply for a pharmaceutical registration, must compile a dossier in accordance with the adopted revised requirements. The revised requirements were adopted by Order No. 409n dated 12 July 2017.

A registration dossier for a pharmaceutical is a set of documents and materials that consist of several parts containing the following types of documents: administrative, chemical, pharmaceutical and biological, pharmacological, toxicological and clinical documentation.

The registration applicant must submit the dossier to the Ministry of Healthcare of the Russian Federation.

Administrative documentation includes:

  • registration application;
  • name and address of the applicant and of the manufacturer of the pharmaceutical as well as place of manufacture, name of the product (international “unpatented”, or group or chemical and trade name); and
  • form of the pharmaceutical, dosage, methods of administration and application and life shelf.

The adopted procedure also sets requirements for:

The volume of information submitted as a part of a dossier for certain types of pharmaceuticals; and

The procedure for the submission of documents that are part of the registration dossier.

The revised requirements apply to registration dossiers submitted to the Ministry of Healthcare after the date Order No. 409n enters into force (i.e. after 20 August 2017).

Law: Order No. 409n of 12 July 2017 on the Adoption of the Procedure for the Compilation of a Pharmaceutical Product Dossier and the Requirements to the Volume and Scope of Information Submitted as a Part of the Dossier