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:
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.
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:
While being an MAH carries significant responsibility, our streamlined cooperation model ensures a smooth process:
With over 20 years of experience as an MAH and in medicinal product registration, SciencePharma has earned the trust of numerous pharmaceutical companies from the EU and beyond. Additionally, SciencePharma is certified according to Good Manufacturing Practice (GMP Certificate) in scope of manufacturing operations for batch certification and medicinal products importation. Our MIA Certificate (Manufacturer / Importer Authorisation covers both: final medicinal products and investigational medicinal products (IMPs). We also offer tailored GMP-compliant quality management system (GMP QMS), to meet your specific needs.
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!