The following Life Sciences guidance note provides comprehensive and up to date legal information covering:
A–B | E–H | I–N | O–P | Q–U.
The CE (Conformité Européene—meaning European Conformity) mark is a mandatory conformity marking for certain products sold within the EEA, including medical devices. It:
shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements
is an indicator of a product’s compliance with EU legislation
allows the free movement of products within the European market
See Practice Note: An introduction to the regulation of medical devices.
One of the procedures available for the authorisation of medicinal products in the EU. It is the mandatory procedure for the following types of medicinal products: products derived from biotechnology, for orphan medicinal products and for medicinal products for human use which contain an active substance authorised in the Community after 20 May 2004 (date of entry into force of Regulation (EC) 726/2004, the EMA Regulation (consolidated version)) and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders or diabetes. Applications for the centralised procedure are made directly to the European Medicines Agency (EMA) and lead to the granting of a European marketing authorisation by the European Commission which is binding in all Member States.
See decentralised procedure, mutual recognition procedure, national procedure and Practice Note: Marketing authorisations—regulatory procedures for approval of medicinal products.
In the context of
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