Genetically modified organisms (GMOs) are officially defined in the European legislation as "organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating or natural recombination". The application of this technology is strictly regulated, and th...
This document describes how the authorities (Member States Competent Authorities or the European Chemicals Agency) can prepare a dossier in accordance with Annex XV to identify a substance of very high concern under REACH. It is part of a series of guidance documents that aim to help all stakeho...
This Handbook is intended to act as a reference for those agri-food producers planning for, or in the process of entering, the Thai market. This Handbook provides step-by-step guides on entering the agri-food market in Thailand including relevant information such as analysis of the Thai market f...
European patients and citizens need access to safe, effective and affordable medicines while the health care system should be financially sustainable, and innovation should be encouraged. This is perhaps the key challenge for the national competent authorities and public payers as pharmaceutical...
This research paper was undertaken at the request of the European Parliament’s Committee on Environment, Public Health and Food Safety. It provides a complementary impact assessment, reviewing and updating the 2008 European Commission Impact Assessment of a proposal for a Regulation replacing Re...
This Handbook is intended to act as a reference for those agri-food producers planning for, or in the process of entering, the Mexican market. This Handbook provides step-by-step guides on entering the agri-food market in Mexico including relevant information such as analysis of the Mexican mark...
The main focus of attention in this study is on various ways in which Member States deal with the pricing and reimbursement of new pharmaceutical products and with regulation considering the timing of market entry for new medicines. The motivation of this focus is that differences between Member...
This manual gives instructions on how to submit applications concerning national authorisations that assist the making available on the market and use of biocidal products, through the Register for Biocidal Products (R4BP 3) according to the Biocidal Products Regulation (BPR) and specifically co...
The new Biocidal Products Regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment....
