LSIPR Newsletter 12:14


MARKETING AUTHORISATION


17


However, there is also another route to securing an MA for a pharmaceutical and it is this other route—under article 10a of the directive, involving demonstrating safety and efficacy through “well-established medicinal use”—which has been the source of much controversy over the years.


Tis route, which was retained in the 2005 amendments, relieves


the MA applicant


from having “to provide the results of pre- clinical tests and of clinical trials if he can


demonstrate that the active substances of the medicinal product have been in well- established medicinal use within the EU for at least ten years, with recognised efficacy and an acceptable level of safety”. Such demonstration is achieved by reference to published literature.


Earlier controversies surrounding this particular route for securing an MA involved attempts to use it to undermine data exclusivity. One occurred more than 20 years ago, in case C-440/93 Scotia, and another in 2010—long


www.lifesciencesipreview.com


aſter the “at least ten years” qualification was introduced into article 10a—in a situation giving rise to the final warning that the European Commission gave to Germany for the actions of its competent authority.


Te actions in question involved taking less extensive use of the active substance, such as in clinical trials, into account in determining the period of well-established medicinal use, and “thereby obscuring the clear separation between different authorisation procedures”.


ZEMLER / SHUTTERSTOCK.COM


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20