Authorisation of medicinal products in the EU
Overview of Authorisation Procedures for Medicinal Products
... a medicinal product’s constituent(s) has a well-established medicinal use, recognised efficacy and an acceptable safety ...a medicinal product constituent must not be less than one decade from that ...
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Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties
... Study limitations The study had a number of limitations. First, it was based only on data from medicines approved in the EU, when they received marketing authorisation from the European Commission and had ...
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authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices
... updated) EU declaration of conformity / EU certificate issued by a notified body / notified body opinion must be submitted in a post- authorisation setting of the medicinal ...
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EU Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals ( REACH )
... the EU for the purposes of product and process orientated research and development (“PPROD”) for a period of five years, extendable to 15 years for substances used exclusively in the development of ...
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POST-AUTHORISATION GUIDANCE. Human Medicinal Products
... marketing authorisation, otherwise the three-year period will start counting for a generic product after expiry of the 10 or 11 years of market exclusivity period of the reference medicinal ...
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Authorisation for early access to medicinal products: HAS assessment doctrine
... 3.2. Guidelines for simplified and high-quality data collection Early access to a medicinal product de facto involves the set-up of data collection. The HAS shall particularly focus on: ‒ Data quality and ...
Marketing Authorisation Expenses for Veterinary Medicinal Products in Northern Europe
... marketing authorisation process is an integral part of the life cycle of a veterinary medicinal product, which the applicant wishes to ...marketing authorisation of veterinary medicinal ...
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Draft Notice to applicants for marketing authorisation for veterinary medicinal products in the European Union, Volume VB Draft, January 1995
... ii) in accordance with Article 8.2 of Directive 81/851/EEC as amended: 'where a Member State notes that an application for authorization submitted after 1 January 1995[r] ...
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Definition of Investigational Medicinal Products (IMPs) Definition of Non Investigational Medicinal Products (NIMPs)
... new medicinal product for HIV patients who need prophylaxis against cytomegalovirus (CMV) is likely to include patients on standard of care medicine(s) for their primary disease ...multi-medicinal ...
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COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) NOTE FOR GUIDANCE ON PLASMA-DERIVED MEDICINAL PRODUCTS
... marketing authorisation - control of starting materials for the production of blood derivatives, EC III/5272/94, and can be provided as part of the dossier as a Plasma Master ...a medicinal product whether ...
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Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials
... used. Medicinal products that do not have a marketing authorisation, but prepared in accordance with a magistral formula, ...and medicinal products prepared in a pharmacy in accordance ...
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COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS
... biological medicinal product claimed to be “similar” to a reference medicinal product, which has been granted a marketing authorisation in the Community on the basis of a complete dossier in ...
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Committee for Orphan Medicinal Products
... have to be confirmed at the time of marketing authorisation. This will be necessary to maintain the orphan status. How is this medicine expected to work? The genetic material of cells (DNA) is normally tightly ...
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Committee for Orphan Medicinal Products
... The sponsor has provided sufficient information to show that 1-cyclopropyl-3-[3-(5-morpholin-4- ylmethyl-1H-benzoimidazol-2-yl)-1H-pyrazol-4-yl]-urea might be of significant benefit for patients with AML because it works ...
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COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS
... What are the methods of treatment available? The treatment of tuberculosis consists of the administration of a combination of antibiotics for long periods of time. Several medicinal products were authorised ...
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COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS
... 1,2-bis(methylsulphonyl)-1-(2-chloroethyl)-2-[(methylamino)carbonyl]hydrazine could be of potential significant benefit for the treatment of acute myeloid leukaemia because it might improve the long- term outcome of the ...
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COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS
... Human heterologous liver cells (for infusion) might be of potential significant benefit for the treatment of ornithine-transcarbamylase deficiency because they might improve the long-term outcome of the patients. The ...
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COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS
... Treatment for leukaemia is complex, and depends on a number of factors including the type of leukaemia, the extent of the disease and whether the leukaemia has been treated before. It also depends on the age, the ...
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Committee for Orphan Medicinal Products
... proteinase 3) could be of potential significant benefit for the treatment of acute myeloid leukaemia because it may act in a different way and it might improve the long-term outcome of the patients. The assumption will ...
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Committee for Orphan Medicinal Products
... immunotherapy and chemotherapies may be used. Another product is also used which blocks (inhibits) growth signals within cancer cells and prevents a series of chemical reactions that cause the cell to grow and divide ...
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