Post-initial Approval Regulation of Medicinal Products
The two previous chapters have discussed the procedures for testing a drug and for obtaining a marketing authorisation (or product licence) which will permit a drug to be commercialised. However, this is only a first step and once a pharmaceutical has received a product licence and been proven, it still remains subject to the regulatory framework of the Medicines Act 1968 in the UK. As yet the EC has had much less effect on this post approval area than on that concerned with the actual securing of approvals, although this is set to change with a number of proposals currently under consideration to introduce EC controls into this area. For this reason, as with the previous chapter, the treatment in this chapter is at a less detailed level than in the rest of the book, focusing on some of the more contentious areas, and the reader is referred primarily to the various EC measures in this area, both actual and proposed, that are set out in the appendices to this book.
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