The Role of an EU Appraisal Representative

An EU authorised representative is a person authorised by a national government to act on behalf of a company or organisation in relation to the EU legislation. A European authorised representative also acts as a legal body designated by a national government to represent them in the EU and make sure that their compliance with the EU Directives is maintained. Each member state has a system of law that allows an organisation to become registered and regulated under its laws. The organisation will be granted an International Trade Office by the EU, allowing it to open new branches and offices in other EU countries, but only to continue to operate within the member state from which it has come. The organisation has to follow the rules and regulations of each country in which it operates.

An EU authorised representative has a mandate to act for the organisation and has no rights of his/her own. If the organisation wishes to conduct business at a particular location, it has to apply for authorisation through the Commission to do so. Once granted permission, the applicant is obliged to comply with all the rules and regulations that have been set down by the EU institution that granted the authorisation. The applicant organisation also has to prepare and implement any plans drawn up by them for achieving its objectives.

There are some important decisions that an authorised representative cannot take on their own. For example the business must not start any new branches until the mandatory procedure has been followed. They cannot decide to close down their present ones or alter the distribution channels until all the infringements have been addressed in full accordance with the law. The obligations of an EU authorised representative do not stop once the application period has expired.

There are certain documents that need to be provided to demonstrate compliance with certain rules and the procedures set out by the EU institution that has granted the organisation permission to operate in the EU. These documents include: corporate registration, establishment forms, trade registration, European company formation, European tax identification number, a European company name registration, European business register, European registration certificate, European certification for firms, European trading license, European commercial invoice, European construction permit and European construction site plan. There is another set of documents that are commonly associated with a business that requires registration under the Lisbon Treat Act: the register of companies for the region, register of securities for the region and register of international organisations. There is also an obligation to provide the EU authorised representative with certain additional documents and information that are specific to the organisation's business, e.g.

The legal requirements of a person wishing to become a European authorised representative of a company must comply with all the rules and regulations that have been set out by the EU institutions. This includes those that relate to the organisation's choice of registration domain and the choice of technical documentation. The technical documentation is particularly important to the EU authorised representative because it gives the organisation the freedom to choose the technical documentation that meets their specific needs. However, it is not enough to be registered: the organisation must also comply with the other technical requirements that have been determined by the competent authorities of the Member States.

The responsibilities of an EU authorised representative also include complying with the legal requirements related to being a representative of a particular company. For example, the EU authorised representative has the responsibility of building up the organisation's links with the regulatory authorities in Member States. He must also ensure that these authorities give their nod to the registration of the organisation as well as taking the necessary actions to ensure compliance by the manufacturer. This is referred to as the manufacturer's responsibility and is a prerequisite in order to ensure that the organisation can continue to trade freely within the EU.

There are two other obligations that come with the role. Firstly, the EU authorised representative has the responsibility of preparing and implementing the guidelines and instructions that are necessary for the submission of the application and for the maintenance of the technical documentation on the manufacture of the substances or products that are under the organisation's obligation. These include the guidelines for the submission of the European standards that must be met by the manufacturer. Secondly, the organisation must ensure that the required indications are included in the technical documentation of the product as well as ensuring compliance with other Union requirements such as those concerning the labeling of the product. The manufacturer is obliged to comply with the various obligations set out in the manufacturer guidebook that comes with the EU technical reporting system.

The manufacturer is also obliged to submit to periodic reviews conducted by the EU authorised representative. These periodic reviews are carried out to ensure that the conditions laid down by the Union's authorities are still being met and to check whether the new pharmaceuticals and technical documents provided by the manufacturer are in line with the Union's indications. In addition, the reports also highlight the problems that may have arisen over the period of time and recommend corrective measures that should be taken to make sure these do not recur in the future.