post-bg-488
calendary February 6, 2024

How to register new dosage form for the approved drug?

With the entry into force of the EAEU Medicines Registration Rules, applicants have the opportunity to follow more flexible regulatory procedures and, for example, add a new dosage form within the framework of an existing registration. In this article, we will look at how you can avoid new registration if you plan to introduce a new dosage form of an already approved drug to the market.

  1. Case

Currently, many marketing authorization holders are planning a procedure for bringing dossiers for drugs into compliance with the requirements of the EAEU. It often happens that during the existence of a drug on the market, companies develop new dosage forms, the dossiers of which are at least 50% identical to the dossier of the approved drug, and therefore it would be logical to register the dossier of a new dosage form based on an already registered drug. This became possible with the introduction of the so-called “extension of registration” procedure, which can be completed after bringing the dossier into compliance with the requirements of the Union.

  1. Procedure

The procedure for extension of registration is described in Decision 78 “On the Rules for Registration and Examination of Medicines for Medical Use” and formally refers to the variation.

The extension of registration applies to certain changes in the active pharmaceutical ingredient (API) and to certain changes in the drug product (changes in dosage, dosage form and route of administration).

To initiate the registration extension procedure, the following documents will be required:

  • cover letter;
  • application for amendments;
  • supporting data regarding the proposed registration extension;
  • complete module 1 of the registration dossier with justification for the absence of data or documents included in the relevant sections of module 1;
  • appropriate update or attachment to quality summaries, non-clinical and clinical reviews. If preclinical or clinical study reports (even just one) are submitted, a summary must be included in Module 2;
  • if the extension affects the summary of product characteristics - labeling or package information leaflet, as well as a quality regulatory document: revised information about the medicinal product, a quality regulatory document should be presented in the appropriate format.

Despite the fact that the type of this procedure relates to variations, the duration of the examination is 140 days (4.5 months).

  1. Advantages

The undoubted advantage of registering a new dosage form on the basis of the “parent dossier” is the reduced amount of paperwork. In addition, due to the fact that the extension of registration relates to the variation procedure, the fee will be 150 thousand rubles instead of 325 thousand rubles.

We will help you plan registration for your case - info@beawire.com

References:
  1. Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 N 78 (as amended on October 20, 2023) “On the Rules for Registration and Examination of Medicines for Medical Use”
  2. “Tax Code of the Russian Federation (Part Two)” dated 08/05/2000 N 117-FZ (as amended on 12/19/2023)

More related posts

new-img-1

Control

Fine for spa resort in Yessentuki

Roszdravnadzor has imposed a fine of 130 thousand rubles on a spa resort in Yessentuki for improper storage of medical products…

03.03.2016
READ ARTICLE
new-img-2

Roszdravnadzor

Roszdravnadzor – patients’ rights

In 2015, Roszdravnadzor restored the rights of more than 460 thousand citizens to effective, accessible, and safe medical…

03.03.2016
READ ARTICLE
new-img-3

Regulation

The certification scheme for medical products hasn’t changed recently

Roszdravnadzor informs that the certification scheme for products in the Russian Federation is determined by Decree of the…

03.04.2016
READ ARTICLE
new-img-4

Control

Fines – Rostov region

In one and a half months of 2016, the Local Agency of Roszdravnadzor in Rostov Region imposed fines of the total amount of…

03.10.2016
READ ARTICLE
new-img-5

Control

Unregistered medical products

Two citizens were fined for selling unregistered medicinal products on the Internet in the Republic of Bashkortostan.

03.10.2016
READ ARTICLE
new-img-6

Control

Unscheduled inspection by roszdravnadzor

Roszdravnadzor started an unscheduled inspection of the Federal State-Funded Institution of Sverdlovsk Region Kirovgrad Central…

03.14.2016
READ ARTICLE
new-img-7

Medical Devices

International medical device regulators forum (IMDRF)

The delegation of the Federal Service for Surveillance in Healthcare headed by Mikhail Murashko, Head of Roszdravnadzor,…

03.17.2016
READ ARTICLE
new-img-8

Pharmaceuticals

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF”

Roszdravnadzor has suspended a series of the preparation “Paratsetomol-UBF” in which pills the metal wire was found.

05.18.2016
READ ARTICLE
new-img-9

Roszdravnadzor

Medical equipment stands idle in the Pskov region

Roszdravnadzor (RZN) statement: the expensive medical equipment for the total amount of 342 million rubles stands idle in…

05.19.2016
READ ARTICLE
new-img-10

Control

Hospital control Jewish autonomous region

Roszdravnadzor has audited the activity of the Regional Budgetary Public Health Facility “Central district hospital of Lenin”…

05.20.2016
READ ARTICLE