Medicines for Human Use Marketing

Significant changes to the legal basis for the exemptions, rather than to their scope, were introduced by the Medicines for Human Use (Marketing Authorisations Etc.) Regulations... 

The Medicines (Exemption from Licences) (Importation) Order 1984 (SI 1984/673). The Medicines for Human use (Marketing Authorisations Etc.) Regulations 1994 (SI 1994/3144). 

Post-authorization evaluation of medicines for human use. This regulatory affairs unit is responsible for issues such as post-marketing surveillance of drugs. 

The new European Directives 2001/82/EC and 2001/83/EC on medicines for human use and veterinary use maintain the mandatory character of the Ph. Eur. monographs in the preparation of dossiers for marketing authorization of medicines, which was instituted in the first directive. Directive 75/318/EEC in 1975. It means that the monographs of the Ph. Eur. must therefore be updated to keep pace with products on the market, with scientific progress, and with regulatory developments. 

Commission Regulation (EC) No. 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State... 

The previous chapters examined the process for the development and authorisation of a drug product containing a ne v active ingredient for human use. This represents the most arduous path to market for any medicinal product. This chapter proceeds to examine the process of bringing a veterinary medicinal product to market. While the process shares most of the principles that apply to human drugs, there are some additional features that are unique to veterinary products. These include methods of use and the requirement to evaluate vithdra val periods and maximum residue limits in food-producing species. 

Volume 2A Notice to applicants—Medicinal products for human use—Procedures for marketing authorisation Volume 2B Notice to applicants—Medicinal products for human use—Presentation and content of the dossier Volume 2C Notice to applicants—Medicinal products for human use—Regulatory guidelines Commission of the European Communities, Luxembourg, 1998/1998/ 1999 (and amendments)... 

The Committee for Medicinal Products for Human use (CHMP). This committee is composed of 35 technical experts drawn from the various EU member countries. It is primarily responsible for formulating the EMEA s opinion on any medicinal product being considered for marketing approval under the centralized procedure. 

Approval of Marketing Authorization Assessment of the application by the Committee for Medicinal Products for Human Use (CHMP) is published initially as a Summary of Opinion—positive or negative. After the granting of a Marketing Authorization by the European Commission, a more detailed report is published as the European Public Assessment Report (EPAR). 

European Commission. Notice to Applicants, Medicinal Products for Human Use, Procedures for Marketing Authorization, Volume 2A of The Rules Governing Medicinal Products in the European Union, EC, 1998. 

The European Commission extended its concerns to pharmaceuticals for human use and, according to Article 8 of the Directive 2001/83/EC [12] (6 November 2001), amended by Directive 2004/27/EC [13] (31 March 2004), an application for a marketing authorization for a medicinal product should be accompanied by an... 

Information on the centralised procedure can be accessed from the EC website (see end of chapter). The EMEA is required to ensure that the opinion of CHMP is given within 210 days after the receipt of a valid application. When an application is submitted for a marketing authorisation in respect of medicinal products for human use which are of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation, the applicant may request an accelerated assessment procedure. If the applicant duly substantiates the request and if the CHMP accepts... 

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