Market authorisation regulation

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... 

A Form 1572 is used for investigators to summarise their educational qualifications and experience, and to make a required formal declaration as to their commitment to conduct the study according to the protocol, GCP and the regulations. The sponsor should also collect financial disclosure information from the investigators at this stage, although formal declarations on Form 3455 are not required until the submission of a marketing authorisation application. 

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... 

Recently, similar legislation has been introduced in the European Union under regulations EC/1901/2006 and EC1902/2006. This requires that marketing authorisation applications for new drugs submitted after the 28 July 2008 must be accompanied by either the results of specific studies demonstrating safety and... 

EC) No. 1085/2003 outline the procedures for processing variations to marketing authorisations granted via National and Community procedures, respectively. The Annexes to the regulations provide criteria for categorisation of changes. 

Risk Class Device Evaluation Quality System Regulations Marketing Authorisation... 

Pharmaceutical products are not sold or supplied before a Qualified Person has certified that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorisation and any other regulations relevant to the production, control and release of medicinal products. 

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... 

Regulation 3(1) of the 1994 Regulations states that no medicinal product may be placed on the market or distributed by way of wholesale dealing, unless it has a marketing authorisation. This replaces the product licence requirement in section 7 of the act. The exemptions to this requirement are provided for by regulation 3(2) and Schedule 1 to the regulations. They permit supply for individual patients and also enable practitioners to hold limited supplies of stocks of imauthorised medicines. The provisions apply equally to doctors and dentists. 

The regulations do not deal with this point. Companies may charge doctors for products supplied to them on a particular patient basis. There are no general Department of Health restrictions on the levels of price or price increase, as the Pharmaceutical Price Regulation Scheme only governs products with a marketing authorisation. 

Section 8(2) of the Medicines Act 1968 requires those involved in the manufacture or assembly of a medicinal product to hold a manufacturer s licence. In fact. Schedule 1 to 1994 Regulations requires the manufacturer/assembler in the United Kingdom of an unlicensed product for particular patient supply to hold a particular type of manufacturer s licence (a manufacturer s special licence). It should also be noted that Section 23 of the act prohibits the manufacture of a medicinal product unless that product has a marketing authorisation, or is exempt from the marketing authorisation requirement. 

On receipt of a valid application via the EMEA, the rapporteur and the co-rapporteur both prepare their separate detailed assessment reports, which are circulated to the EMEA and all other Member States by day 70 from the start of the procedure. The new Regulation requires that the duration of the analysis of the scientific data in the file concerning the application for marketing authorisation must be at least 80 days, except in cases where the rapporteur and co-rapporteur declare that they have completed their assessment before that time. 

The provisions of the new Regulation (EC) 726/2004 do not affect the powers of Member States authorities as regards setting the prices of medicinal products or their inclusion in the scope of the national health system or social security schemes on the basis of health, economic and social conditions. In particular, Member States shall be free to choose from the particulars shown in the marketing authorisation those therapeutic indications and pack sizes which will be covered by their social security bodies. 

Permanand G, Mossialos E, McKee M. Regulating medicines in Europe the European Medicines Agency, marketing authorisation, transparency and pharmacovigi-lance. Clin Med 2006 6(l) 87-90. 

Under Annex IV of EU Council Regulation 2377/90 no MRL can be assigned to this compound and as such marketing authorisation for this compound has been withdrawn. However, under Directive 70/524EEC the compound is authorised for use only in turkeys and guinea fowl. No residues of this compound were detected in the 125 pig kidney samples analysed. However, dimetridazole was detected in pig feed samples at concentrations of 110/xg/kg, 130/xg/kg, 1,300 /xg/kg and 2,200 /xg/kg. 

One ham sample contained residues of the hydroxy- metabolite which is common to dimetridazole and ronidazole. Both these products are listed in Annex IV of Council Regulation 2377/90, i.e. compounds for which no MRL can be set and for which marketing authorisation has been withdrawn. 

Regulation 2377/90 contains the following four annexes in which the substances are listed after evaluation I. Substances for which final MRLs have been fixed II. Substances for which MRLs are not deemed necessary in order to protect public health III. Substances with provisional MRLs - if a dossier is incomplete, the manufacturer may be given a set time (up to five years) in which to provide the necessary information IV. Substances for which it is not possible, due to safety concerns, to set an MRL - the administration of substances listed in this annex is prohibited throughout the EU and the marketing authorisation for the medicines concerned has been withdrawn. 

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