European Union Market
Marketing Authorization Holder Services
Assisting businesses in obtaining the CE marking for your products.
Medical Device
IVD
ENQUIRE NOW
What is Marketing Authorization Holder Services?
A Marketing Authorization Holder (MAH) is the entity responsible for obtaining and maintaining regulatory approval of CE Marking for a medical device or IVD in the EU. Marketing Authorization is the person or company who is licensed to distribute, sell and commercialize a medical product. The holder of the marketing authorization is the person who applies for the registration of the medical device and has filed with the local Medical Product Administration or already got approved.
Why is Marketing Authorization Holder Services important?
Compliance
Appointing a MAH is a critical step in ensuring compliance with EU regulations, and failure to appoint a competent and reliable MAH can lead to delays or even the inability to market your medical device or IVD in the EU.
Market Access
Our MAH services provide expert guidance to help you meet all regulatory requirements and maintain compliance, allowing you to focus on developing and marketing your products with confidence.
Process Flow for Marketing Authorization Holder Services
Understand Regulatory Requirements: Gain a thorough understanding of the specific regulatory requirements for your product category in the EU.
Evaluate the Need for a MAH: Determine if you require the services of a Marketing Authorization Holder (MAH). Depending on your product and regulatory framework, appointing a MAH may be necessary for market entry in the EU.
Identify a Qualified MAH: Research and identify qualified MAH service providers that specialize in your industry or product category. Look for companies with a proven track record, expertise in regulatory compliance, and knowledge of the EU market.
Engage with the Selected MAH: Initiate discussions and negotiations with the chosen MAH service provider. Clarify their scope of services, responsibilities, and the terms of the agreement.
Prepare Documentation: Collaborate with the MAH to prepare the necessary documentation required for marketing authorization.
Regulatory Submissions: Work closely with the MAH to submit the required applications and documentation to the relevant regulatory authorities. The MAH will typically handle the submission process on your behalf and communicate with the authorities throughout the review process.
Maintain Compliance: Continuously monitor regulatory changes and updates that may affect your product’s marketing authorization.
Communication and Collaboration: Maintain regular communication and collaboration with the MAH. Keep them updated on any changes to your product, manufacturing processes, or other relevant information.
Periodic Review and Renewal: Ensure that your marketing authorization remains valid by undergoing periodic reviews and renewals as required by the regulatory authorities.
How can we help in Marketing Authorization Holder Services?
The CliniExperts professionals will -
Assist you with all the documentation required for market authorization.
Fulfill all the requirements specific to your product and market entry goals.
Handle the submission process on your behalf and communicate with the authorities throughout the review process.
Initiate the renewal process well in advance to prevent any disruptions in market access.
Regulatory requirements for Marketing Authorization Holder Services
Timeline
The timeline for MAH services can vary depending on several factors, including the type of medicinal product, the regulatory pathway chosen (e.g., centralized, decentralized, or national procedure), and the complexity of the application. The process of obtaining a marketing authorization can take several months to a year or more.
Regulatory Body
The regulatory body responsible for overseeing MAH services in the EU is the European Medicines Agency (EMA). The EMA is the central authority that assesses and authorizes medicinal products through the centralized procedure.
Fees
The fees associated with MAH services can vary depending on the type of application, the regulatory pathway, and the applicable regulations. The fee structure is typically determined by the regulatory authorities and may include components such as application fees, evaluation fees, and annual fees for maintaining the marketing authorization.
Validity
Once a marketing authorization is granted, it is valid unless it is voluntarily withdrawn by the MAH or revoked by the regulatory authorities due to non-compliance or safety concerns.
