Medicinal products in the EEA

 

The pharmaceutical/medicinal sector is extensively regulated at EEA level in order to ensure the highest possible protection of public health and patient confidence in safe, effective and high-quality medicinal products.

Marketing authorisations

In order to guarantee the highest possible level of public health and to secure the availability of medicinal products to citizens across the EEA, all medicinal products for human and animal use are required to be authorised either at national or Community level.

The mutual recognition procedure allows national marketing authorisations granted by an EEA State to be recognised in the other EEA States.

Special rules exist for the authorisation of certain medicinal products, such as those used in paediatrics, orphan drugs, herbal products, vaccines and clinical trials.

Good manufacturing practices

In order to ensure that medicinal products are consistently produced and checked, quality standards known as Good Manufacturing Practice (GMP) have been laid down. Compliance with GMP is mandatory within the EEA.

Detection of adverse effects

Once medicinal products have been authorised in the EEA and placed on the market, the supervision and monitoring of those products, as well as the possibility to withdraw a problematic product from the market quickly, is carried out through a co-ordinated system called pharmacovigilance.

Veterinary medicinal products

Special rules apply to veterinary medicinal products in order to ensure that consumers are protected against active substances used in food-producing animals. Those rules contribute to guaranteeing a high level of animal health and welfare in the EEA.

European Medicines Agency

In order to ensure the highest possible protection of public health, the European Medicines Agency (EMEA) was established in 1994. Its main task is to co-ordinate the scientific evaluation of the quality, safety and efficacy of medicinal products and to provide scientific advice of the highest possible quality. The EFTA States have participated in the work of EMEA since January 2000.

Relevant links:




Other EEA Institutions


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