регистрация лекарственных средств

Pharmaceuticals registration is an integral part of activities in the course of drug introduction to the Russian market. In September of 2010 the new federal law No. 61-ФЗ “About Pharmaceuticals Circulation” came out which sufficiently amended the procedure of pharmaceuticals registration.

The process consists of two stages:

  1. The procedure of receipt of permit for pursuance of the clinical research (if necessary).
  2. The procedure of expertise of drug quality, efficiency and safety.

Please note that the following categories of drugs are subject to mandatory state registration:

  • drugs of own manufacture;
  • licensed drugs;
  • the new mixture of already registered drugs;
  • the already registered drugs reproduced in another dosage, another pharmaceutical form.

Please note that the following categories of drugs are not subject to mandatory state registration:

  • drugs manufactured under prescription by the persons having necessary license for pharmaceutical activity with consideration of requirements of various medical, veterinary organizations;
  • drugs purchased by private individuals abroad of the Russian Federation and brought into the country for personal use;
  • radiogenic drugs for oncology treatment manufactured by the very medical institutions;
  • medicinal plant raw materials.

Also remember that it is not allowed to register the drugs:

  • of one manufacturer with the same ingredients but under different names;
  • with different ingredients but with the same trade name.

Pharmaceuticals registration procedure takes:

  • 210 business days — for original drugs;
  • 60 business days  — for generic drugs.

These terms exclude the period of time spent for pursuance of the clinical research. State registration of pharmaceuticals is a quite labour-intensive process, time consuming and challenging, requiring solid knowledge in this field. Sufficient problems can arise already at the stage of collection of necessary documents which must comply with regulatory requirements. We offer making registration process as simple, quick and cheap as possible.

Registration of pharmaceutical products and pharmaceuticals. The stages:

  • study of submitted documentation;
  • rendering consultations with executive body specialists;
  • singing of the agreement between the customer and the contractor;
  • pre-registration preparation of documents;
  • pharmaceutical expertise;
  • pursuance of clinical tests (individually);
  • issue of registration certificate.

Services of Nadim CRO Company on pharmaceuticals registration

The company offers any types of services on legal arrangement of drugs and pharmaceuticals in the Russian Federation. We guarantee rendering high quality consultation services to our clients, support projects on introduction of pharmaceuticals to the market with the aim of their further promotion. Our specialists will save your time and money by effective fulfillment of a complete set of operations or offering separate services:

  • preparation of the registration dossier;
  • development of normative documentation;
  • pursuance of pre-clinical and clinical research;
  • registration support;
  • receipt of registration certificate;
  • translation of medical text;
  • introduction of amendments into pharmaceutical documentation;
  • preparation of instructions on medical application of drugs, regulatory documents / manufacturer's monograph and so on.