What Is Marketing Authorization Holder
A Marketing Authorization Holder (MAH) is the entity legally responsible for obtaining and maintaining the marketing authorization of a medicinal product. This ensures that the medicine is safe, effective, and of high quality.
In the pharmaceutical industry, the Marketing Authorization Holder (MAH) refers to the entity that bears the legal responsibility for obtaining and holding the marketing authorization of a medicinal product. The MAH is entrusted with the crucial task of ensuring that the product in question meets the highest standards of safety, efficacy, and quality. This involves extensive testing, documentation, and compliance with regulatory requirements. Ultimately, the MAH is accountable for all aspects of the product, from its initial development through to its marketing and ongoing surveillance.
Who is a marketing authorisation holder?
A marketing authorisation holder is a legal entity or company that has been granted the authorisation to market a medicine in one or more of the European Union Member States. This authorisation allows the company to sell and distribute the medicine within the region, and to be responsible for ensuring that the product meets the required standards of safety, efficacy, and quality. Marketing authorisation holders are a key player in the European Union's regulatory system for medicines, and work closely with regulatory authorities to ensure the ongoing safety and efficacy of their products.
Where is a centralised marketing authorisation valid?
A centralised marketing authorisation, once granted by the European Commission, is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.
What is the application dossier for marketing authorisation?
The application dossier for marketing authorisation is a comprehensive and detailed collection of data and information about a pharmaceutical product that is submitted to regulatory authorities for approval to market the product. In the USA, this dossier is called a New Drug Application (NDA), while in the European Union and other countries, it is called a Marketing Authorisation Application (MAA) or simply registration dossier. The information included in this dossier typically encompasses preclinical and clinical trial data, manufacturing details, and information on the product's safety, efficacy, and quality. The application dossier represents a critical step in obtaining regulatory approval for a pharmaceutical product and must meet extensive regulatory requirements in order to be considered for approval.
How long is a marketing authorisation valid for?
A marketing authorisation is typically valid for a period of 5 years in most countries. Upon expiration of this period, an application for renewal of the marketing authorisation must be submitted, typically requiring minimal data to confirm that the product's quality, efficacy, and safety characteristics remain unchanged, and that the risk-benefit ratio of the medicinal product is still favourable.
The centralised procedure grants a valid marketing authorisation for a medicinal product throughout the entire EU, allowing it to be sold in all Member States.
What is the type of marketing authorisation procedure?
The type of marketing authorisation procedure depends on the medicine and the pharmaceutical company's intended market, either in several member states of the EU or throughout the entire EU/EEA.
What is the centralised European authorisation procedure?
The centralised European authorisation procedure is a regulatory process for the approval of certain drugs, particularly those with new active substances for severe diseases, within the European Union. The procedure requires the submission of an application to the European Medicines Agency, followed by a scientific evaluation by the Committee for Medicinal Products for Human Use. Upon completion of the evaluation, the European Commission grants or refuses approval of the drug for marketing in the EU. The centralised procedure is mandatory for certain types of drugs and can also be chosen optionally.
How do I apply for centralised Medicinal Product Authorisation?
To apply for centralised Medicinal Product Authorisation, companies must submit their application directly to the European Medicines Agency (EMA). The application will undergo a validation process to ensure that all necessary information has been provided, after which it will be subject to a scientific evaluation by the EMA. The application should include comprehensive data on the quality, safety, and efficacy of the medicinal product, and comply with all relevant regulatory requirements. The EMA provides guidance and support throughout the application process, including pre-submission meetings to help companies prepare their application.
The process of converting a marketing authorisation into a standard marketing authorisation involves the fulfilment of obligations imposed upon the marketing authorisation holder and confirmation through full data analysis that the benefits of the medicine remain superior to its risks. Upon meeting these conditions, a standard marketing authorisation may be granted, which no longer entails specific obligations. It is worth noting that this status is valid for a period of 5 years.
How long does it take to adopt a marketing authorisation decision?
The adoption of a marketing authorisation decision following the centralised procedure should occur within 67 days of receiving the opinion of the European Medicines Agency (EMA). The decision is subsequently notified by the Commission's Secretariat-General to the holder of the marketing authorisation and published in the Union Register.
What if a marketing authorization is not subject to specific obligations?
In certain cases, the CHMP may recommend granting a Marketing Authorisation without specific obligations if comprehensive data on the efficacy and safety of the product is available and all specific obligations have been fulfilled. The renewal and annual re-assessment of such a marketing authorization would not be subject to specific obligations.
The term "Marketing Authorization Holder (MAH)" is frequently employed in the context of the pharmaceutical industry. It pertains to the legal entity that bears the ultimate responsibility for obtaining marketing authorization for a medicinal product. The MAH is bound by regulatory requirements, necessitating the assurance of product safety, efficacy, and quality. Ensuring that all requisite obligations are met is an important part of the role of the MAH.
What is a marketing authorization number?
A marketing authorization number is a distinct identification code assigned to a medical product. It typically starts with two digits representing the member state, followed by a series of numbers indicating the marketing authorization itself, and concluding with a sequence of five digits assigned in sequence.
What is marketing authorization transfer?
Marketing authorization transfer refers to the formal process of transferring the rights and responsibilities associated with the marketing authorization of a medical product from one company or individual to another. This may involve the transfer of licenses to manufacture or sell the product, or other legal agreements related to the commercialization of the product. It is a formal process that requires proper legal documentation and compliance with applicable laws and regulations. The purpose of marketing authorization transfer is typically to allow other entities to capitalize on the benefits of a medical product, while providing the original owner with compensation or other benefits in exchange for transferring their rights.
The Marketing Authorization Holder (MAH) is the responsible entity in the pharmaceutical industry that holds legal responsibility for the marketing authorization of a medicinal product.
What is a marketing authorization holder (Mah)?
A Marketing Authorisation Holder (MAH) is an organisation that holds the legal responsibility for the marketing authorisation of a medicinal product. As such, the MAH is accountable for all aspects of the product, including its safety, efficacy, and quality. The MAH is also responsible for the compliance with regulatory requirements, including pharmacovigilance and post-market surveillance. In the context of serialization, the MAH owns the serialization data and is the entity responsible for uploading this data to the relevant regulatory authorities. The MAH works in collaboration with the manufacturing authorization holder (MA) who holds the license to manufacture the product.
What is a manufacturing authorisation holder?
A manufacturing authorization holder is a term used in the FMD that refers to an entity that holds a license to manufacture medicinal products.
What is a transfer of Marketing Authorization (MA)?
A transfer of Marketing Authorization (MA) is a procedure wherein the approved Marketing Authorization Holder (MAH) transfers the authorization to a new MAH, who is a different person or legal entity.
Certainly. The complete application dossier required for obtaining marketing authorisation for a medicinal product is officially called a New Drug Application (NDA) in the United States or a Marketing Authorisation Application (MAA) in the European Union and other jurisdictions. Alternatively, this dossier may be referred to simply as a registration dossier.
What is marketing authorization?
The process of reviewing and assessing a dossier to support a medicinal product for marketing authorization involves the evaluation of the quality, safety, and efficacy of the product. This process is carried out by regulatory authorities in order to ensure that only safe and effective medications are made available to the public. The process typically involves the submission of a New Drug Application (NDA) or a similar document that outlines the scientific data supporting the product's use, along with manufacturing information, labeling, and other important details.
Marketing authorization is the result of a successful marketing approval process, where the regulatory authorities have granted permission for a pharmaceutical company to market and sell a given medicinal product in a specific geographic region or country. This document, which may go by other names such as licensing, registration, or approval, represents the official permission granted to the company to market their medication in a particular area. This is a critical step in the commercialization of a new drug and allows the product to go to market in a legal and regulated manner.
What is a drug dossier?
A drug dossier refers to a thorough and comprehensive scientific document that is prepared and submitted as a requirement for obtaining worldwide licensing approval or market authorization of a drug by diverse health authorities. It is an essential file used in the drug approval process, containing detailed information on the drug's quality, safety, efficacy, and overall benefits and risks associated with its usage. The dossier plays a vital role in the drug approval process by providing regulators with the necessary information to make informed decisions about the safety and effectiveness of a drug.
How does the European Medicines Agency guide applicants/marketing authorisation holder on oral explanations?
The European Medicines Agency provides guidance to applicants and marketing authorisation holders on oral explanations during the assessment of new marketing authorisation applications in the centralised procedure. This guidance is available in marketing authorisation guidance documents. The time allowed for applicants to respond to questions and issues raised during the assessment is also addressed in these documents. It is recommended that applicants maintain a formal tone when summarising this guidance.
