Medicinal Products Directive

Amended by Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products. Directive 2001 /83/EC on the Community code relating to medicinal products for human use Amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use... 

Ten years later, three directives sought to further promote public health and the free movement of medicinal products within the community. Directive 75/318/EEC [2] set analytical, pharmacotoxicological, and clinical standards for testing proprietary medicinal products, Directive 75/319/EEC [3] established the Committee for Proprietary Medicinal Products (CPMP) and its partial mutual recognition procedure, whereas Directive 75/320/EEC [4] established a Pharmaceutical Committee to examine problems in implementing the pharmaceutical directives. 

Difficult borderline questions arise in relation to a significant number of products, particularly whether they are to be classified as medicinal products or as MDs. As a general rule, a relevant product is regulated either under the MDDs or by the medicinal products Directives (MPDs). Normally, the procedures of both Directives do not apply cumulatively. The Commission has issued guidelines on this drug-device borderline issue and also on what constitutes MDs, AlMDs and accessories. In order to decide which regime applies, the relevant criteria are ... 

Doc-Biocides-2002/01 Version 08.01.2008, Guidance document agreed between the Commission services and the competent authorities of the Member States for the Biocidal Products Directive 98/8/EC and for the Medicinal Products for Human Use Directive 2001/83/EC and the Veterinary Medicinal Products Directive 2001/82/EC Borderline between Directive 98/8/EC concerning the placing on the market of biocidal products, Directive 2001/83/EC concerning medicinal products for human use and Directive 2001/82/EC concerning veterinary medicinal products. 

Manufacturers, importers and wholesalers may only sell medicinal products directly to pharmacies emd they may, if authorised by INFARMED, after hearing the opinion of the Department of Competition and Prices also ... 

INFARMED and the Department of Competition amd Prices shall jointly ensure that each authorisation granted under the terms of the previous paragraph be published in the Diario da Republica and that a list of the bodies authorised to acquire medicinal products directly be published annually. 

Corporate information must be scientific, technical or financial in nature (e.g. a company s annual report) and must not promote a medicinal product. A company s medicinal products, direction, and research and development activities can be referred to only on the condition that it is for information purposes only and not promotional. 

A new block of directives gives details on practical aspects for the rational use of medicinal products. Directive 92/25/EEC concerns the distribution from the producer to the dispenser. According to this directive, distribution of medicinal products must be in accordance with good distribution practice (GDP) only approved products may be distributed, and may be delivered exclusively to persons authorized for supplying the public in the concerned country. 

An example of how the Medical Device Directive (MDD) and Medicinal Product Directive (MPD) are applied is outlined below for injection products [1,14] ... 

Herbal Medicinal Products Directive (2004/24/ EC) (THMPD) (European Union, 2004). Coming into force in 2011, the Directive will bring consistency and regulation to the herbal medicines market across Europe. In additional to concerns over safety, the increased amount of wild crafting is raising sustainability questions. Of the 40,000-50,000 plant species used in herbal medicines, 70% are wild crafted and 4,000 of those face extinction. The opportunity for commercial cultivation of medicinal herbs has been reviewed (Williamson and MacTavish, 2007). The study identified up to 36 species of plants suitable for cultivation in Northem European agroclimatic conditions or under controlled conditions. The authors reviewed potential volumes and prices and the species with greatest potential for economic development are shown in Table 3. 

EC Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. 

Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004... 

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products... 

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. 

Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use... 

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. 

The authorisation of generic medicinal products is covered by Article 10 of the Human Medicines Directive 2001/83/EC and Article 13 of the Veterinary Medicines Directive 2001/82/EC. A generic drug is defined as a medicinal product that has ... 

All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in Article 1 of Directive 2001/83/EC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class III. 

Figure 11.3 Basic topics addressed by the EU CMP Directives for medicinal products.

Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. 

According to Article 40 of Directive 2001/83/EG (human medicinal products) and Article 44 of Directive 2001/82/EG (veterinary medicinal products), pharmaceutical... 

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