Manufacturer as Marketing Authorization Holder
The marketing authorization is retained under the manufacturer's own company, keeping direct ownership of the registration and its lifecycle.
Different commercial strategies require different registration structures. URAS PV helps you choose and coordinate the marketing authorization structure that fits each market.
In some markets, pharmaceutical manufacturers prefer to retain the marketing authorization under their own company or an eligible local entity. In others, registration may be structured through a local distributor or another authorized applicant.
URAS PV helps clients evaluate the available registration arrangements based on their business objectives, local regulatory requirements, and long-term market strategy.
Whether your preferred model involves the manufacturer, a local distributor, or another eligible Marketing Authorization Holder, URAS PV can coordinate the appropriate registration process, subject to the requirements of each country.
The marketing authorization is retained under the manufacturer's own company, keeping direct ownership of the registration and its lifecycle.
The marketing authorization is held by an eligible local entity in the target country, where this structure suits the market and its requirements.
Registration is structured through a local distributor or another authorized applicant, subject to the requirements of each country.
Our goal is to help clients establish a regulatory structure that supports both compliance and their intended commercial presence in the market.
Registration of pharmaceutical products, food supplements, and medical devices in accordance with the relevant national or regional regulatory frameworks.
New drug registration detailsRenewal 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 detailsPrice registration, price declarations and reference pricing documentation where pricing approval is required before launch.
Price registration 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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