MAH Service - Marketing Authorization Holder shouldering responsibility
The Marketing Authorization Holder (MAH) term refers to a company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States. MAH is the entity which takes the responsibility for ensuring compliance with the standards set out in European Union (EU) legislation and guidelines. A number of duties lie within MAH in distinct areas. Among them there are obligations regarding clinical trials, products manufacturing in accordance with Good Manufacturing Practices (GMP), overview of the supply chain, investigation of complaints, quality issues and pharmacovigilance activities. Although some of these may be often delegated, the responsibility still remains with the MAH.
At Health-Med, we offer an extensive range of regulatory services, including acting as the Marketing Authorization Holder (MAH service) for your medicinal products.
Health-Med’s MAH service allows to transfer the responsibilities of Marketing Authorization Holder to Health-Med who will fulfill all the duties resulting from MAHs function.
The MAH service is addressed to all entities that do not want to or can’t perform the duties of a marketing authorization holder on their own or under their own authority. There are many situations in which it is worth using the MAH service, the following are just a few of them.
- MAH service for companies interested in applying for a Marketing Authorization (MA): At Health-Med we assist companies in registration procedure under national procedure, the decentralized procedure (DCP) or the mutual recognition procedure (MRP) while acting as the MAH.
- MAH service for non-EU medicinal products: At Health-Med we provide MAH service for manufacturers who wish to market medicinal products in EU (including manufacturers from third countries).
- We may also assist in commercial transactions of confidential sale or purchasing of marketing authorizations (MA) for each medicinal product, their dossiers or in any other case, when you need us to represent your company as MAH under our name.
How does the cooperation go for Health-Med's MAH service?
Although being MAH is a great responsibility, there are no difficult things for Health-Med and the cooperation model is simple.
- Contact Health-med with an order for MAH service.
- Send us the registration documentation, in particular Module 3 (if necessary, we can help in its preparation).
- Together, we will determine the scope of cooperation, representation and related obligations, as well as define the time frame for the MAH service to finally sign the contract.
- Finally, you don't have to worry about anything, because everything is in the hands of Health-Med, which completes all formalities in the Agencies based on the client's strategic decisions.
Our company has over 15 years of experience in the fields of function as Marketing Authorization Holder and drugs registration. Pharmaceutical companies from EU and non-EU countries have used our support many times and often come back to us, which undoubtedly proves the high quality of services provided by Health-Med.
What is more, Health-Med is certified according to Good Manufacturing Practice (GMP) as manufacturer responsible for batch certification of the products and importer. Our GMP certification covers both: final medicinal products and investigational medicinal products (IMPs). If you need a comprehensive GMP compliant quality management system (GMP QMS), we can provide the services tailored to your needs.
Depending on the individual necessities of the company, we can also coordinate other shouldering responsibilities - such as Qualified Person (QP) - through our MAH service, as well as the registration procedure with a very wide range of support starting from pre-authorisation phase ending with post-registration service covering variations (including OTC switches, MAH transfers), renewals, sunset clause exemptions and more.
If you are interested in MAH service, please, do not hesitate to contact us. We will be glad to arrange a meeting with our Experts to answer all your questions.