Recognition mutual

The mutual recognition procedure is an alternative means by which a marketing authorization may be sought. It is open to all drug types except products of biotechnology. Briefly, if this procedure is adopted by a sponsor, then the sponsor applies for a marketing licence not to the EMEA, but to a specific national regulatory authority (chosen by the sponsor). The national authority then has 210 days to assess the application. 

If adopted by the national authority in question, the sponsor can seek marketing licences in other countries on that basis. For this bilateral phase, other states in which marketing authorization are sought have 60 days in which to review the application. The theory, of course, is that no substantive difficulty should arise at this stage, as all countries are working to the same set of standards as laid down in The Rules Governing Medicinal Products in the European Union . 

A further 30 days is set aside in which any difficulties that arise may be resolved. The total application duration is 300 days. If one or more states refuse to grant the marketing authorization (i.e. mutual recognition breaks down), then the difficulties are referred back to the EMEA. The CPMP will then make a decision ( opinion ), which is sent to the European Commission. The Commission, taking into account the CPMP opinion, will make a final decision that is a binding. 

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The main purposes of the System of accreditation is to ensure reproducibility of measurements, harmonisation of rules and procedures of the National system of accreditation with guidelines of international organizations and national systems of different countries, creation of conditions for mutual recognition of the results of testing, calibration, attestation. 

Chapter 4 Mutual recognition procedure chapter 4 Mutual recognition procedure... 

Outside of the products that come within the scope of Community Authorisations, all other products can only be licensed via application to the Competent Authorities of individual Member States. However, through the use of either decentralised or mutual recognition procedures it is possible to obtain authorisations on the basis of a dossier assessment conducted by a single Member State. 

Annex I listing is the prerequisite for the mutual recognition of authorizations between Member States, whereby one Member State is obliged to accept the evaluation and authorization prepared by another Member State in situations where the agricultural, plant health, and environmental (including climatic) conditions relevant to the use of the plant protection product are comparable in the regions concerned (Article 10 of the Directive). ... 

Inclusion in Annex I is the prerequisite for the mutual recognition of authorizations between Member States. At the time Directive 91/414/EEC was adopted in 1991, there were over 800 a.i. authorized for use in the Member States. The goal was to evaluate these at Community level within 12 years. However, the resources necessary to carry out this exercise were not fully recognized when the legislation was adopted. Moreover, time-consuming decision procedures delay the review process. Up to February 2002, 15 existing a.i. and 13 new a.i. were listed in Annex I, whereas 19 a.i. were rejected (see also Table 1). There is clearly a lack of mutual recognition between Member States. 

The Directive will operate by listing all active substances which can be used in biocidal products in a list (annex I to the Directive) and requiring that only those active substances listed can be used in biocidal products. Member states will then authorise biocidal products to a set of common principles (annex V of the Directive) with a system of mutual recognition of authorisations. 

There are three procedures by which pharmaceutical products may gain a marketing authorization in the EEA. These are the National, Mutual Recognition, and Centralized procedures. 

The first of these can be used when a product is to be marketed in a single country. It can be used for any type of application except for certain types of biotechnology-based items. Having been approved in one country, in most cases an application to a second country will trigger the Mutual Recognition procedure in other concerned countries. There are certain exceptions to this, e.g., where a product has different summaries of product characteristics (SmPCs) in different countries, and these have not been subjected to a harmonization procedure. Line extensions to such products could also remain subject to national procedures. 

The zinc fingers are common structures among the transcription factors. Nevertheless, the coordination with zinc is more frequently produced between two histidine residues and two neighboring cysteines than when it is among four cysteine residues, as occurs in the nuclear hormone receptors. The zinc fingers provide an optimum architecture for the mutual recognition between specific sequences of amino acids and nucleotides. In the case of the nuclear receptors, the interaction occurs between particular amino acids of the DBD and guanine residues of the DNA sequence (Fig. 1.7). 

The special case in kin recognition studies is mutual recognition of mothers and newborn infants. Presumably, olfaction plays a crucial role in the mother-infant first contact and the linking-up of their mutual relationship. 

In general, the registration process in the EU allows one to either apply to an overall medicines authority or to an individual national authority. Either of these steps is supposed to lead to mutual recognition by all the individual members. 

As a result of the adoption of the above directives legislation is now in place to ensure that there is confidence not only in national laboratories but also those of the other Member States. As one of the objectives of the EU is to promote the concept of mutual recognition, this is being achieved in the laboratory area by the adoption of the AMFC directive. The effect of the AMFC Directive is that organisations must consider the following aspects within the laboratory its organisation, how well it actually carries out analyses, and the methods of analysis used in the laboratory. All these aspects are inter-related, but in simple terms may be thought of as ... 

Thus, as for the European Union, the requirements are based on accreditation, proficiency testing, the use of validated methods of analysis and, in addition, the formal requirement to use internal quality control procedures which comply with the Harmonised Guidelines. Although the EU and Codex Alimentarius Commission refer to different sets of accreditation standards, the ISO/IEC Guide 25 1990 and EN 45000 series of standards are similar in intent. It is only through these measures that international trade will be facilitated and the requirements to allow mutual recognition to be fulfilled will be achieved. 

AstraZeneca launched omeprazole in 1988. It is a safe and effective drug for acid reflux, functioning as a proton pump inhibitor. However, the patent has expired and AstraZeneca has to compete against generics. The company developed the active isomer and called it esomeprazole. It was approved by the Mutual Recognition process in Europe in July 2000, and by the US Food and Drug Administration in February 2001. The chemical formulas for omeprazole and esomeprazole are shown below. 

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