National Authorisations

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 applications for national authorisations are submitted to the national competent authority which, in the United Kingdom, is the Licensing Authority (LA), whose functions are discharged by the Medicines and Healthcare products Regulatory Agency (MHRA, previously Medicines Control Agency, MCA) of the Department of Health. The LA/MHRA are advised by the CSM, a multidisciplinary scientific body consisting of clinical, preclinical and pharmaceutical members well known for their expertise in their respective fields. Lay members are also included. 

Marketing authorisations in the European community can be obtained at present by two main procedures - mutual recognition of a national authorisation from one Member State or a community-wide authorisation through a procedure known as the centralised procedure. In November 2005, a new procedure, known as the decentralised procedure, will be introduced under the new legislation. 

Apart from some differences in detail, similar procedures operate for national authorisation in almost all EU Member States. 

When an applicant has obtained one national authorisation (within an European Union country), any ongoing assessment of that product in other EU Member States is suspended and the first authorisation granted is entered for mutual recognition by all or selected (depending on the choice of the applicant) Member States. 

Applications, which are the subject of an MRP, result in national authorisations and attract national fees. However, if they are incoming from another MS they will have undergone full review in the recent past. Consequently, the assessment process is less onerous and, in recognition of this, the fee is reduced to Irish 4,200. 

Exceptions to the provisions of the above paragraph are medicinal products imported from countries with which the EU h is agreements, when the agreement waives the need for a national authorisation to import. 

A medicinal product with a national marketing authorisation has a national registration number, e.g. RVG 11,985 in the Netherlands. Product information about nationally authorised medicines can normally be found on national websites. National Medicinal Agencies refer to the website of the EMA if the product has obtained a European Marketing Authorisation. 

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

In a sense, the articles equate to what you might expect to find in an Act at national level, while the content of Annexes would be more akin to what would be placed in regulations. There is also a parallel in terms of authorisation, in that amendments to the articles usually require the approval of the political institutions, whereas adaptation of the Annexes to technical progress is possible via a decision of the Commission, functioning as the executive body. You can see this in practice by just looking at the title of each instrument that you read. 

Evaluation of applications for drug marketing authorisations made either directly to the national authority or indirectly via the centralised procedure to the EMEA... 

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... 

EC) No. 1085/2003 outline the procedures for processing variations to marketing authorisations granted via National and Community procedures, respectively. The Annexes to the regulations provide criteria for categorisation of changes. 

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

Antioxidants should be labelled on the retail package with the specific chemical name or with the EC number. The legislation of member states of the EU is influenced by the decision taken within the EC. Some food standards are fully based on EC Directives and some are still based on national considerations. There may be differences between European states, for instance, the utilisation of ascorbic acid as antioxidant for egg products is permitted in France but prohibited in Germany. These differences concern usually the utilisation of antioxidants in various food commodities. The specification of antioxidants mentioned in EC Directives are respected by all member states. But it is still generally required that individual countries of the European Union as well as the central organisation should be approached. The requirements appearing in the EC Directives on additives must be applied by the member states. This means in the first place that for those categories of additives for which a Community positive list exists, member states may not authorise any additives which do not appear on the positive list. 

This directive is concerned with the authorisation and the placing on the market of biocidal products. It attempts to establish a list of active substances that may be used in biocidal products within the EC. In order to assess which substances should be included in the list, a system of registration, authorisation and periodic evaluation is legislated with this Directive. Once approved, active substances will be incorporated into Annex I of the directive. The system of registration is created for active substances, which pose a low riskfor humans, animals and the environment and will be incorporated in Annex lA. In Annex I B so called basic substances such as are listed. For products of higher concern, usually not an active substance, an authorisation system is established, that includes the formulation of dossiers on these products which need to be submitted to the respective national authority. In Annex I B... 

The basic requirements for the contents of the dossier of information accompan)dng the application for a marketing authorisation are the same whether it is submitted nationally or centrally and were laid out in detail in Directive 715/318/EEC and its subsequent amendments. These requirements were included as Annex 1 of the codified Directive 2001/83/EC. 

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