MAH Service – Marketing Authorisation Holder shouldering responsibility
The term Marketing Authorisation Holder (MAH) refers to a company or legal entity holding the authorization to market a medicinal product within one, several, or all European Union (EU) Member States. The MAH is responsible for ensuring that all requirements and regulations outlined by EU legislation and guidelines are fully met. This includes several critical obligations, such as:
- Ensuring that medicinal products are manufactured in compliance with Good Manufacturing Practices (GMP),
- Overview of the supply chain,
- Investigating complaints and resolving quality issues,
- Managing pharmacovigilance activities.
Although certain tasks can be delegated to third parties, the MAH ultimately retains full responsibility for the product’s compliance and safety.
At SciencePharma we offer a comprehensive range of regulatory services, including acting as the Marketing Authorisation Holder for your medicinal products. By partnering with us, under MAH service, you can transfer the responsibilities of the MAH role to SciencePharma. We will manage and fulfil all duties associated with this critical role, ensuring compliance with EU regulations and maintaining the highest standards of product oversight.
Who can benefit from our MAH service?
Our MAH service is designed for companies or entities that either prefer not to or are unable to take on the responsibilities of a Marketing Authorisation Holder themselves. Outsourcing these responsibilities under our MAH service can be particularly beneficial in situations such as:
- Companies interested in applying for a Marketing Authorisation (MA): SciencePharma supports companies in registration procedure under national procedure, the decentralized procedure (DCP), or the mutual recognition procedure (MRP), while acting as the MAH,
- Non-EU manufacturers of medicinal products: We provide MAH service for manufacturers outside the EU seeking to market medicinal products in European Union (including manufacturers from third countries),
- Assistance in commercial transactions: We provide support during the confidential sale or acquisition of Marketing Authorisations (MA) for each medicinal product, their dossiers or in any other case, when your company requires a representative MAH under our name.
How does cooperation with SciencePharma’s MAH service work?
While being an MAH carries significant responsibility, our streamlined cooperation model ensures a smooth process:
- Contact us with us with a request for MAH service.
- Submit your registration documentation, especially Module 3 (we can assist with preparation if needed).
- We will collaboratively define the scope of cooperation, representation and related obligations, as well as establish timelines for the MAH service, culminating in the contract.
Trust the experts
With over 20 years of experience as a MAH and in medicinal product registration, SciencePharma has earned the trust of numerous pharmaceutical companies from the EU and beyond. Additionally, SciencePharma holds a MIA licence and a GMP certificate for manufacturing operations, including batch certification and the storage of imported and EU-manufactured medicinal products. Our MIA license covers both final medicinal products and investigational medicinal products (IMPs). We also offer a tailored GMP-compliant quality management system (QMS) to meet your specific needs.
Comprehensive support throughout the entire medicinal product registration process
Depending on your needs, we can also manage additional shouldering responsibilities, such as providing Qualified Person (QP service). We offer full support at every stage of the registration process, from pre-authorisation phase to post-registration services, covering variations (including OTC switches, MAH transfer), renewals, sunset clause exemptions and more.
If you are interested in our MAH service, do not hesitate to contact us. We would be glad to arrange a meeting with our Experts to answer all your questions.
Contact us for detailed information!