Medicines for Human Use Marketing Authorisations

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). 

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)... 

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... 

European Commission. Rules relating to marketing authorisation of medicinal products for human use. Council Directive 75/318/EEC. Luxembourg Office for Official Publications of the European Communities, 1998. 

Rules Relating to Marketing Authorisation of Medicinal Products for Human Use and Related Council Directives 81I852IEEC, 91/507/EEC and 92/18/EEC Plus Council Recommendations 83/571 /EEC and 87/176/EEC Office for Official Publications of the European Communities Luxembourg, 1998. 

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001, on the approximation of the laws, regulations and administrative provisions of the member states, relates to the implementation of GCP in the conduct of clinical trials on medicinal products for human use. The commimity code relating to medicinal products for human use (2001/83/EC) was amended in 2003 (2003/63/EC), stipulating that clinical trials data used for marketing authorisation applications in the EU are required to be conducted in accordance with GCP. 

The procedures for obtaining a Community marketing authorisation are defined in EC Regulation No. 726/2004. The types of human-use medicinal products for which the procedure may be used are shown in Eigure 6.14. The applicant should notify the EMEA of their intention to submit an application at least 7 months... 

Regulation EEC/2309/93 also laid down Community procedures for the authorisation and supervision of medicinal products for human or veterinary use. It established two procedures for obtaining entry to the markets of the Member States, namely the multistate or decentralised or mutual recognition procedure and the centralised procedure . Figures 15.1 and... 

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