5.2) international registration procedure

Internationally on the other hand, other registration procedures are in effect. Especially within the Member States of the European Union (EU) the implementation is quite smoothInside the borders of the EU, there are two recognized registration procedures. 

 

Mutual recognition/decentralized procedure. 

The registration is initialized in one Member State. For the remaining Member States, a permit can be requested. This permit only applies in the concerning Member State. For other States, another individual permit should be requested. This rests upon the principle of recognition of qualifications, which is an agreement in which is established that products in the EU should meet certain criteria. The effect of such an agreement is that most products should have a certain quality and leads to a more liberalized application. Because a registration in one Member State is recognized in other Member States, this is called the mutual recognition procedure. 

 

Centralized procedure. 

Next to the mutual recognition procedure, an applicant can also start the registration on a central level. The leading authority in Europe regarding the registration of medicinal products is the European Medicine Agency’s (EMA) Committee for Medical Products for Human Use (CHMP). The EMA is an agency, installed by the EU, and has been burdened with the responsibility of evaluating the development, efficacy and safety of medicinal products. As the agency has a lot of responsibilities, some responsibilities are delegated to committees, one of which is the CHMP. The CHMP is the primary contact for issues regarding medicinal product use in humans. Tasks of the committee are divided in different departments: safety, efficacy, biological mechanism of action, and specialization. If the committee approves the application, the medicinal product can be used everywhere in Europe.