MarketingAuthorizationmeans all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.
What is a marketing authorization (MA)?
Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.
Who is responsible for centralised marketing authorisation?
Marketing authorisation The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.
What is a marketing authorization holder (Mah)?
Marketing Authorization Holder means a legal entity to whom a medicinal product marketing authorization has been granted and which is legally responsible for the safety, efficacy, and quality of the medicinal product; Sample 1 Sample 2 Based on 2 documents
What is a marketing authorization number (map)?
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.
How long is a medicinal product authorization valid?
In most countries, a marketing authorization is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorization, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable. However, in the European Union, after one renewal, the marketing authorization shall remain valid for an unlimited period, unless the competent regulatory authority decides otherwise.
What is the process of reviewing and assessing the dossier to support a medicinal product in view of its marketing?
Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), obviously finalized by granting of a document also called marketing authorization (equivalent: product license). This process is performed within a legislative framework which defines the requirements necessary for application to the concerned (competent) regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria) and the grounds for approval or rejection of the application, and also the circumstances where a marketing authorization already granted may be withdrawn, suspended or revoked.
What is special consideration?
Special consideration is to be given to application for authorization of biological products and biotechnology products, homeopathic products, herbal drugs, radionuclide generators, kits , radionuclide precursor radiopharmaceuticals and industrially prepared radiopharmaceuticals; in such instances, requirements are specific, in the meaning that they are special, more or less detailed, as per the nature of active ingredient.
Can a marketing authorization be revoked?
Marketing authorization may be also withdrawn, suspended or revoked if the marketing authorization holder or its representative does not fulfill other legal or regulatory obligations necessary to maintaining of product on the market, as per the legislation in force.
Who fills the drug application?
The application is filled with the competent drug regulatory authority in the concerned country, which can be an independent regulatory body or a specialized department in the ministry of health.
Is authorization a national or international process?
Authorization processes follow either a purely national procedure, with rules and requirements as per national legislation in force, as it occurs in most of countries worldwide, or should follow a centrally approval or a mutual recognition or decentralized procedure within the European Union.
