Marketing authorisations European Commission

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)... 

Cefic claims that polymeric materials, reaction intermediates and substances used for R D should not be subject to the REACH evaluation and authorisation process being proposed by the European Commission in its White Paper on future chemicals policy, it is briefly reported. On specific issues, Cefic wants a risk-based approach to chemicals assessment and regulation realistic deadlines for the REACH process and exemption from REACH of finished articles, so that it applies only to substances marketed as substances or as constituents of a preparation. 

In the European Union, a medicinal product may only be placed on the market when the competent authority of a Member State for its own territory (national authorisation) has issued a marketing authorisation or when the European Commission (EC) has granted an authorisation for the entire Community (Commimity authorisation). 

Variations. Pharmaceuticals Regulatory framework and market authorizations, Chapter 5, in Procedures for Marketing Authorisation, Vol. 2A, European Commission, available http //ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/a/v2a chap5 rl 2004-02. pdf, accessed Apr. 16, 2006. 

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. 

In the European Union there have been several petitions to approve stevia and its products. In 2000, the EU Commission refused marketing authorisation for Stevia rebaudiana Bertoni plants and dried leaves as a novel food or novel food ingredient (Official Journal of the European Communities, 2000). In October 2003, the SCF rejected a request to re-examine the restrictions on the uses of extracts of stevia. Its comment, after throroughly examining the evidence, was that the committee has serious doubts about the safety of stevioside and does not consider it acceptable for use in food (European Parliament, 2003). 

The BPD introduced a European scheme for authorisation of biocidal products. The Directive was closely based on an earlier authorisation directive dealing with plant protection products (agricultural pesticides). The context within which the Commission views biocidal products can be seen from the fact that the Directive was originally, in early drafts, called the Non-Agricultural Pesticides Directive . It is therefore not surprising that the Biocidal Products Directive introduces an onerous authorisation scheme that aligns with a previously stated EC requirement to reduce the number of pesticides on the EU market. The Directive came into force on 14 May 1998 and had to be implemented in all Member States within 2 years. Many Member States, including the UK, were late. 

Under the decision-making matrix measures to control occupational exposure at national levels would continue to operate under legislation based on Article 138 of the European Commission Treaty and most environmental emissions would be controlled through legislative frameworks based on Article 175 (see Sections 2.4.3 and 5.3.1). When effective enforcement mandates the control of specific products or processes at the EU level, restriction and authorisation would apply following Article 95 on the internal market. 

The completion of harmonisation of rules for plastic food contact materials and articles is within sight. The finalisation of the positive list for authorised additives is likely to happen in 2008. In 2007 the Commission will, besides the Community list of authorised additives, publish a list of additives authorised at national level for which a valid application for EU authorisation has been made to EES A. Only these substances may be used until evaluation is finalised by EES A and a decision on authorisahon is taken by the European Commission. Another project in the plastics sector is the extension of the rules to multimaterial multilayer structures where the plastic layer is in contact with the food. At this moment only plastic materials which consist entirely of plastic are covered by the plastics Directive. These materials, when they are made up from layers of plastic, constitute only about 15% of the mutilayer market. Other multilayer materials such as beverage cartons, which consist of a food contact layer of plastic and aluminium and/or paper, are not yet covered by specific legislation. Extension of the plastics mles to these materials will have to take into consideration requirements for the non-plastic layers and establish mles for migration testing of these materials. 

In certain cases companies may wish to obtain more than one marketing authorisation for the same medicinal product, through either simultaneous or subsequent applications. A specific procedure has been agreed for this between the EMEA and the European Commission. Under this procedure, companies should inform both the EMEA and the Commission Services at the latest four months prior to submission of their intentions, in particular providing the Commission with an explanation of the underlying motives for the multiple application and their intentions regarding exploitation of any authorisations granted. 

The new EU Directive was the subject of a dispute that occurred in early 2002, especially with the United States. According to official spokesmen, the US was ready to launch a trade war over European plans to label all GM food. The European Commission considers that it has now fulfilled its commitment to create conditions for restarting the authorisation procedure for GMOs (thus avoiding being sued by the US under WTO rules). Companies must now decide what products they want to put on the market, and member states are responsible for initiating the authorisation procedure. 

Health claims are a very convenient tool when it comes to marketing functional foods due to consumers sensitivity to health-related communications. The use of nutrition and health claims on foods in the European Union (EU) was harmonised in 2006 by Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (EC, 2006). Only the use of authorised nutrition and health claims is allowed. All health claims require specific authorisation by the European Commission (EC) through the comitology procedure, following the scientific assessment and verification of a claim by the European Food Safety Authority (EFSA) (Pravst, 2012a). 

REACH. In 2003 the EU Commission proposed a new chemicals policy -REACH (Registration, Evaluation, and Authorisation of Chemicals). The biocides used in AF products are still registered through the BPD, but the other paint constituents as with all other chemical constituents produced or imported > 1 ton/year on the European market will need to be partly or fully risk assessed under REACH. The legislation is expected to enter into force in 2007 (EU, 2003b). 

EC. 2003. EU Commission Decision of 5 Jime 2003 authorising the placing on the market of "noni juice" (juice of the fruit of Morinda citrifolia L.) as a novel food ingredient imder Regulation (EC) No 25% 197 of the European Parliament and of the Council. 

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