Marketing authorisations European Union

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

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... 

Wathion, N. (2001) EMEA Public Statement on the Recommendation to Suspend the Marketing Authorisation for Orlaam (levacetylmethadd) in the European Union, EMEA, London. 

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). 

The period of market exclusivity is 10 years from authorisation of the product. In the context of market exclusivity in the European Union, a Member State must not accept another application for a marketing authorisation or grant a marketing authorisation or accept an application to extend an existing marketing authorisation for the same therapeutic indication in respect of a similar medicinal product. However, exclusivity may be lost by the first applicant consenting to a second application from another applicant, if the first is unable to meet demand, if a similar product is found to be clinically superior, if the criteria are no longer met or if, at the end of 5 years, a Member State can show that the product is (excessively) profitable. 

Once a medicinal product is authorised in the European Union, even if it is not marketed, the MAH is required to submit a PSUR. These PSURs were previously required to be prepared at 6-monthly intervals for the first 2 years following the medicinal product s authorisation in the European Union, annually for 2 years, at the first renewal, and then 5-yearly at renewal thereafter. However, as shown later. Regulation 726/2004 has increased the frequency of PSURs. 

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). 

Smoke flavourings have to be authorised before entering the market both in USA and the European Union (EU). 

National marketing authorisations were intended to be phased out from 1 January 1998. It was foreseen that beyond that date, all marketing authorisations within the European Union would have been issued under the rules governing medicinal products in the European Community through the Centralised Procedure, or the so-called Mutual Recognition or Decentralised Procedure (see below). However, national approvals for marketing have continued well beyond 1 January 1998. 

Under the mutual recognition procedure, the applicant company usually ends up receiving national marketing authorisations from some or all of the national drug regulatory authorities to whom the dossier is submitted. The centralised procedure, on the other hand, is all or none , and under it the applicant company would receive a single marketing approval from the EMEA valid in all European Union countries. Rejection of an application under the centralised procedure means that the product cannot be marketed in any Member State. 

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). 

Compassionate use is a treatment option that allows the use of an unlicensed medicine. Compassionate use programmes are for patients in the European Union (EU) who have a disease with no satisfactory authorised therapies or cannot enter a clinical trial. They are intended to facilitate the availability to patients of new treatment options under development. To qualify for a compassionate use programme, the manufacturer calls on the national authorities for permission. The manufacturer must submit a request for the granting of a marketing authorisation or he must perform research in the context of a research programme with a cohort. Compassionate use procedures are also applicable for unlicensed medicines withdrawn from the market or for off-label use of licensed medicines. 

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