For more information: Prior authorisation guidelines – Section 2: Pre-application steps The Committee for Medicinal Products for Human Use (CHMP) evaluates applications for marketing authorisation submitted under the centralised procedure, with the Pharmacovigilance Risk Assessment Committee (PRAC) providing input on certain aspects of the risk management plan and the Committee for Advanced Therapies (CAT) for medicinal products of advanced therapy. The application fees for a national procedure, a mutual recognition procedure and a decentralised procedure must be paid to Fimea. ** The protection of an authorised medicinal product from generic competition that goes beyond the protection of data exclusivity. During this period, applications for generic medicines may be accepted and authorised, but generic medicines cannot be placed on the market. Marketing authorisations for medicinal products are dynamic, not static, and the dossier underlying a marketing authorisation must be updated regularly. This will ensure compliance with scientific progress and the new legal requirements set out in Article 23 of Directive 2001/83/EC, Annex I to Directive 2001/83/EC and Article 16 of Regulation (EC) No 726/2004. Applicants must use the Electronic Common Technical Document (eCTD) format and submit their application through the electronic submission gateway or web client. The appropriate legal basis depends on the type of application you are making. The legal bases are as follows: Regulations 51 to 53 have been updated to take account of the different types of application. Once granted by the European Commission, the centralised authorisation is valid in all EU Member States as well as in the countries of the European Economic Area (EEA), Iceland, Liechtenstein and Norway. If you have any questions about the legal basis for your submission, you can send RIS.NA@mhra.gov.uk an email. You can find out about changes to reference medicines for new generics or other abridged marketing authorisation applications.
The structure of the application documents must conform to the Common Technical Document (CTD) format. The application dossier is usually submitted in electronic form (eCTD or NeeS) either to the national authorities (national procedure, MRP or FAD) or to the EMA (centralised procedure). An application for a marketing authorisation for a medicinal product is called an `application for informed consent` if it has the same qualitative and quantitative composition, in terms of substance or active substances and pharmaceutical form, as a reference medicinal product already authorised, according to that dossier. Such an application is subject to the condition that the consent of the marketing authorisation holder of the reference medicinal product has been obtained for the three modules containing pharmaceutical, pre-clinical and clinical data (modules 3, 4 and 5). Permanent access to such documents or possession of information should be guaranteed. The combination of active ingredients within a single pharmaceutical form according to the legal basis is what is known as a “fixed combination”. A hybrid application differs in some cases where results from non-clinical or clinical trials are required. These applications rely partly on the results of preclinical and clinical trials for a reference product and partly on new data. Following the evaluation, the CHMP issues a scientific opinion on whether or not the medicine can be authorised. The EMA forwards this opinion to the European Commission, which grants the marketing authorisation.
We have advice on how to apply for orphan designation products from the MHRA. In addition, an authorised generic medicinal product may not be placed on the market until ten years after the first authorisation of the reference medicinal product. The ten-year period from the first authorisation of the reference product provides for a market protection period** for the reference product. More information on the submission of electronic application documents A marketing authorisation may be applied for under the national, decentralised or mutual recognition procedure. The procedure is described on the main page. The evaluation of data relating to an application for a marketing authorisation for a medicinal product shall be carried out in the context of an ex ante control. To qualify for a marketing authorisation, the medicinal product must be effective, safe and of sufficient quality. This is assessed by checking the results of clinical and non-clinical trials carried out with the drug and reports on the quality of the substance. This information serves as the basis for an evaluation statement and a proposal for a decision. In particular, any information that may influence the evaluation of the benefits and risks of the medicinal product must be submitted without delay. In this context, marketing authorisation holders granted in accordance with Article 10 or 10c of Directive 2001/83/EC should make rapid variations where the marketing authorisation of the reference medicinal product is amended in order to address safety or efficacy concerns. In addition, the marketing authorisation holder should inform the competent authorities of any pharmacovigilance problems referred to in Article 104 of Directive 2001/83/EC.
The pilot project aims to help regulators understand why there may be delays in placing certain medicines on the market in EU Member States after obtaining a marketing authorisation. The legal basis for all types of applications is defined in the legal instruments: for complete applications, the results of pharmaceutical tests (physicochemical, biological or microbiological), pre-clinical tests (pharmacological and toxicological) and clinical studies must be submitted. The detailed data requirements are set out in Annex I to Directive 2001/83/EC, as amended by Commission Directive 2003/63/EC. (all CTD modules described in detail above). If the EMA needs additional information to complete its validation of the application, it will request the applicant to provide it within a deadline. An application for authorisation may be based on complete or abbreviated documentation. Preparations for which the marketing authorisation is based on a complete set of documents are called reference medicinal products. An abbreviated set of documents may be used to apply for marketing authorisation for a generic or biosimilar preparation.
The full legal bases are described in Articles 8 and 10 of Directive 2001/83/EC on medicinal products for human use and the FIMEA Regulation on applying for and maintaining a marketing authorisation for a medicinal product (PDF). The type and amount of additional data to be provided shall comply with the relevant criteria set out in Part II of Section 4 of Annex I to Directive 2001/83/EC and the relevant detailed guidelines. Due to the diversity of biological medicinal products, the competent authorities will determine the need for further pre-clinical and clinical trials. The reference medicinal product chosen shall be a medicinal product authorised in the Union on the basis of a complete dossier in accordance with Article 8 of Directive 2001/83/EC. You must provide the appropriate legal basis for your application when applying for authorisation from the MHRA. Types of applications for marketing authorisation of a medicinal product Legal basis: Article 8(3) of Directive 2001/83/EC At the time of submission of a generic/hybrid application, the period of data exclusivity* of the reference medicinal product must have expired in order for the applicant to rely on the dossier of the reference medicinal product. Data exclusivity is at least eight years after authorisation in the EU. Only a complete Module 1 needs to be submitted for the request for informed consent, including the electronic application form with the relevant annexes and the approval of the authorised medicinal product allowing access to Modules 2, 3, 4 and 5 of the original dossier and any documents submitted subsequently. The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorisations in the European Union (EU). This authorisation procedure allows pharmaceutical companies to submit a single marketing authorisation application to the EMA and to market the medicine throughout the European Economic Area on the basis of a single marketing authorisation and make it available to patients and healthcare professionals. The national procedure shall, where appropriate, follow the instructions of the decentralised procedure. The applicant shall submit a summary of product characteristics (SPC), package insert and packaging label in Finnish already included in the original application documentation.
The first assessment statement is completed approximately 120 days after receipt of the application. From 25. In March 2021, applicants for marketing authorisations for orphan drugs and drugs for the treatment of cancer will be invited to participate in a pilot project by voluntarily and confidentially declaring their intention to launch them. Legal basis: Article 10(4) of Directive 2001/83/EC; Section 4 of Part II of Annex I to Directive 2001/83/EC For instructions on compiling the application dossier and the application forms themselves, consult the European Commission`s guidelines for marketing authorisation applicants: Notice to applicants, Volume 2B – Presentation and content of the dossier For these applications, modules 1, 2 and 3 shall be submitted in accordance with the provisions of Annex I to Directive 2001/83/EC. For modules 4 and 5, a detailed scientific bibliography with all necessary non-clinical and clinical features should be treated and summarized in module 2. They are considered complete and independent applications. If parts of the file are incomplete, these absences must be justified in the non-clinical/clinical overviews as for any other complete application. This type of application concerns information contained in the marketing authorisation dossier for the reference medicinal product. A marketing authorisation for the reference medicinal product has been granted on the basis of a complete dossier in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC.