Mandatory Price Registration
In some markets the price of a medicine must be registered with the competent authority before the product can be sold.
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.
Depending on the country and product category, these requirements may represent an additional regulatory step before commercial launch or continued marketing.
In some markets the price of a medicine must be registered with the competent authority before the product can be sold.
Applicants may need to declare prices to the authorities and keep these declarations up to date.
Proposed prices may be compared with the prices of the same product in reference countries.
Further pricing controls may apply depending on the country and the product category.
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.
Registration of pharmaceutical products, food supplements, and medical devices in accordance with the relevant national or regional regulatory frameworks.
New drug registration detailsMarketing authorization held by the manufacturer, an eligible local entity, a local distributor or another authorized applicant.
Registration models and MAH optionsRenewal of existing marketing authorizations and registration certificates, with ongoing support to maintain your registrations throughout their lifecycle.
Drug license renewal detailsPreparation and submission of regulatory variations and amendments reflecting changes to the registered product.
Drug variation detailsTrademark availability searches, filing and maintenance through local intellectual property specialists.
Trademark registration detailsMAH arrangements, price registration, trademark protection, and an overview of our full registration support.
All registration servicesTell us about your products and target countries, and our regulatory team will outline the registration pathway.
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