Medicinal products presentation

Medicinal products presented for an entirely new indication which, in the opinion of the EMEA, are of significant therapeutic interest... 

The information with respect to a medicinal product must promote the rational use of the medicinal product, presenting it in an objective way, without exaggeration of its properties. 

European Commission Notice to Applicants, Veterinary Medicinal Products. Presentation and Contents of the Dossier, 2004 (available at http //ec.europa.eu/ health/files/eudralex/vol-6/b/vol6b 04 2004 final en.pdf accessed 12/06/10). 

Established in 1909 as Pharmaceutical Chemistry name changed in 1920 to Chemistry of Medicinal Products present name adopted in 1927. 

The CTD format has been incorporated into the E U regulations and is set out in the revised version of Annex I to directive 2001/82/EC, which was published as Commission Directive 2003/63/EC. It is also supported by detailed guidance in the Rules Governing Medicinal Products in the European Union, Volume 2B - Presentation and content of the dossier - CTD2001 edition. The relationship between the CTD format and the previous four-section format that was used in the E U is shown in Table 6.1. 

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 latter session included government perspectives from the EPA OPPTS, the EPA Office of Research and Development, the EPA Office of Children s Health Protection, the OECD, the EMEA and the Committee for Medicinal Products for Human Use (CHMP), in addition to industry perspectives reflecting both the chemical and pharmaceutical industries.19 The NIEHS/NIOSH workshop was limited to 23 invited participants. A limited number of background scientific presentations were given, and the emphasis was on break-out group sessions in which a series of predetermined questions were raised and key points were captured by rapporteurs.17... 

The company that applies for approval of the generic product must present full chemical and pharmaceutical documentation. If the new product does not fall within the definition of a generic medicinal product compared to the reference product the results of the appropriate pre-clinical tests or clinical trials should be provided (EU 2001 specific Article 10 (3)). It should be noted that the pharmaceutical and chemical quality is strictly regulated and includes all medications. 

Drug Safety Evaluation has been written with the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologies to patients, health care providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated. 

European Commission. Notice to Applicants, Medicinal Products for Human Use, Presentation and Content of Dossier, Volume 2B of The Rules Governing Medicinal Products in the European Union, EC, 1998. 

In early 2007, the EMEA reported the analysis of GMP deficiencies in its document entitled Good Manufacturing Practice An Analysis of Regulatory Inspection Findings in the Centralised Procedure. It detailed the deficiencies reported in 435 inspections of manufacturers of medicinal products and starting materials in the European Union and third countries in the period 1995 to 2005. Altogether there were 9465 deficiencies, of which 193 were critical (2%), 989 major (10%), and 8283 (88%) others. The top 20 deficiencies are presented in Table 10.1. 

The packaging of a medicinal product fulfils a variety of roles such as product presentation, identification, convenience and protection until administration or use. Selection of packaging requires a basic knowledge of packaging materials, the environmental conditions to which the product will be exposed and the characteristics of the formulation. Several types of packaging will be employed, the primary packaging around the... 

The Commission and the CSM also made recommendations on the introduction of many other broad safety measures. These included the Phen-acetin Prohibition Order (SI 1974/1082), presentation of medicines in relation to child safety (SI 1975/2000), and declaration of alcohol in medicinal products on their package as active ingredient where this is likely to be pharmacologically active. Other labelling issues culminated in an Order (SI 1976/1726) that set out the standard particulars that must be shown on the containers and packaging of medicinal products. Consultations on other generally applicable warnings on the labels of certain medicines to protect children and to ensure that... 

Directive 75/318/EEC required that the dossier be presented in four highly structured parts Parts I, II, III, and IV. Directive 83/570/EEC was the amending Directive, which introduced the requirements for a draft SPC to be produced by the applicant. Volume 2B of The Rules Governing Medicinal Products in the European Union gave a detailed breakdown of the structure of a European regulatory dossier. This format was accepted until the end of June 2003 when a new format known as the Common Technical Document (CTD) became mandatory (see later). 

An application for a marketing authorisation must be accompanied, among other items, by specified pharmaceutical, preclinical and clinical particulars and documents (the dossier ). Three important summary documents in the dossier are the SPC, a Package or Patient Information Leaflet (PIL), and the sales presentation of the product (label). The SPC has a formally prescribed structure (Box 17.1), and forms the basis for authorised chnical prescribing of the medicinal product concerned. 

The PEG has been transformed into Paediatric Working Party in relation to implementation of Regulation (EC) No 726/2004. On 29 September 2004, the EC released the first proposal for a Regulation on Medicinal Products for Paediatric Use together with an explanatory memorandum, the Extended Impact Assessment and questions and answers document. The proposal has now been presented to the Council of Ministers and the European Parliament and it will go through the co-decision procedure. The earliest that the proposal is likely to become law is late 2006. 

Article 3 provides the criteria for classifying a medicinal product as subject to medical prescription. These are products that are likely to present a danger either directly or indirectly, even when used correctly, if utilised without medical supervision or are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health or contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation or are normally prescribed by a doctor to be administered parenterally. Thus a medicinal product that meets any of these criteria is subject to a medical prescription and a medicinal product that does not meet these criteria is not subject to a medical prescription. 

For mutual recognition applications. Article 29 of Directive 2001/83/EC provides that where a Member State considers that there are grounds for supposing that the marketing authorisation of the medicinal product concerned may present a risk to public health, it shall forthwith inform the applicant, the RMS, other CMSs, and the EMEA. The Member State must state its reasons in detail and indicate what action may be necessary to correct any defect in the application. 

Table 3.2. List of chapter titles present in the Guide to Good Manufacturing Practice in the European Community (i.e. Vol. IV of the Rules Governing Medicinal Products in the European Union)...

The present guidance does not lay down detailed requirements for specific classes of biological products, and attention is therefore directed to other guidelines issued by the Committee for Proprietary Medicinal Products (CPMP), e.g. the note for guidance on monoclonal antibodies and the note for guidance on products of recombinant DNA technology The Rules Governing Medicinal Products in the European Community, Volume III). 

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