Registration

Price Registration and Regulatory Pricing Support

In certain CIS and Eurasian markets, pharmaceutical products may be subject to mandatory price registration, price declarations, reference pricing mechanisms, or other governmental pricing controls.

Pharmaceutical Pricing Requirements in CIS and Eurasian Markets

Depending on the country and product category, these requirements may represent an additional regulatory step before commercial launch or continued marketing.

01

Mandatory Price Registration

In some markets the price of a medicine must be registered with the competent authority before the product can be sold.

02

Price Declarations

Applicants may need to declare prices to the authorities and keep these declarations up to date.

03

Reference Pricing Mechanisms

Proposed prices may be compared with the prices of the same product in reference countries.

04

Other Governmental Pricing Controls

Further pricing controls may apply depending on the country and the product category.

How URAS PV Supports Price Registration

We coordinate pricing procedures together with the product registration, so that pricing approval does not delay your market entry.

Our integrated approach helps clients align product registration and pricing-related regulatory activities with their intended market entry timelines.

URAS PV supports clients in navigating applicable pharmaceutical pricing procedures, including:

  • Assessment of country-specific price registration requirements
  • Preparation and coordination of pricing application documents
  • Support with external reference pricing documentation and pricing justifications
  • Submission coordination with competent local authorities
  • Price registration renewals and updates, where required
  • Regulatory follow-up throughout the pricing approval process

Other Registration Services

New Registration

Registration of pharmaceutical products, food supplements, and medical devices in accordance with the relevant national or regional regulatory frameworks.

New drug registration details

Flexible Registration Models

Marketing authorization held by the manufacturer, an eligible local entity, a local distributor or another authorized applicant.

Registration models and MAH options

Drug License Renewal

Renewal of existing marketing authorizations and registration certificates, with ongoing support to maintain your registrations throughout their lifecycle.

Drug license renewal details

Drug Variation

Preparation and submission of regulatory variations and amendments reflecting changes to the registered product.

Drug variation details

Trademark Registration

Trademark availability searches, filing and maintenance through local intellectual property specialists.

Trademark registration details

Our Regulatory Affairs Services

MAH arrangements, price registration, trademark protection, and an overview of our full registration support.

All registration services

Planning to enter a new market?

Tell us about your products and target countries, and our regulatory team will outline the registration pathway.

Contact Us