MHRA
MA
A marketing authorization holder (MAH) is the person or company who is licensed to distribute, sell and commercialize a medical product.
The holder of the MAA in the European Union is usually the MAH who was first to market a product in that region.
The period during which an MAH has sole rights over a particular medicine varies between members of the European Union. However, all countries have common requirements for how long this period may last. These are included in the European Union Directive on the protection of proprietary medicinal products.
The holder of a marketing authorization is responsible for ensuring that companies manufacturing and distributing them comply with current laws and regulations as well as those in place at the time it was first authorized.
While the holder ensures that all companies involved in these activities are properly licensed, they may not be responsible for any errors or omissions by other companies.
The holder must also notify all health authorities in the European Union of any changes to their authorization as well as major changes made to a product’s list of ingredients, container and packaging materials.
In addition, they should be aware that the European Union requires them to submit an annual report.
The holder must ensure that no unauthorized changes are made to the product, either by altering its physical characteristics or composition.
Changes which do not affect the quality of a product can be made without an additional MAA.
However, some European Union countries require the MAH to gain approval for these type of changes, while others will allow the product to remain on the market until a decision is made.
The FDA marketing authorization holder is responsible for ensuring that companies manufacturing and distributing them comply with current laws and regulations.
While the holder ensures that all companies involved in these activities are properly licensed, they may not be responsible for any errors or omissions by other companies.
The holder must also notify all health authorities in the United States of any changes to their authorization as well as major changes made to a product’s list of ingredients, container and packaging materials.
In addition, they should be aware that the United States requires them to submit an annual report.
The holder must ensure that no unauthorized changes are made to the product, either by altering its physical characteristics or composition.
Marketing authorization transfer is the process of transferring rights over a medical product.
This can include everything from licensing production to selling or commercializing it.
Companies may choose to transfer their marketing authorization for any number of reasons, including increased market share, improved financial conditions or ceasing operations.
The process of transferring a marketing authorization can take up to a year and requires approval from the European Union and any member states in which the product is currently available.
A marketing authorization number is a unique code given to a medical product.
The first two digits on a marketing authorization number represent the member state.
The first six or seven numbers after the letter M refer to the marketing authorization number itself, while the final five numbers are assigned sequentially.