UK: MHRA has published a new guideline about borderline products
Management of borderline products is a topic issue for manufacturers and Competent Authorities. The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a new guideline to provide more details about the classification of borderline products and the applicable regulations. The guideline address the most common questions of manufacturers, details MHRA position and provide the overview of UK and European legislation.
The aim of this guidance is to help to make a right decision about the classification of products.