The Bolar Exemption

Activities covered by the exemption

The exemption would in our view cover the following activities:

The carrying out of chemical and biological synthetic processes suitable for the making, disposal or keeping of the active substance(s) including the manufacture or the import of batches in quantities sufficient to provide material for preparing investigative batches of the medicinal product and to validate the processes to the satisfaction of the competent authorities.

The development, testing and use of the associated analytical techniques for the above.

The development of the final pharmaceutical composition and manufacturing processes for the medicinal product to be marketed including the making, disposal or keeping or import of product batches in quantities sufficient to conduct the necessary pre-clinical tests, clinical and bioavailability trials and stability studies of the medicinal product and to validate the processes to the satisfaction of the competent authorities.

The development, testing and use of the associated analytical techniques for the above.

The manufacture and supply to the competent authorities of samples of active substances, their precursors, intermediates or impurities and of finished product samples.

The compilation and submission of a MA or Variation application and application for a MA.

It is our view that non-infringing studies, tests and trials can be carried out from the 30 October 2005 as long as those activities are for the purposes of submitting an application under Article 10 paragraphs 1 - 4 of the 2001/83 Directive (or Article 13, paragraphs 1 - 5 of Directive 2001/82/EC).  This would apply regardless of whether the reference products were submitted for authorisation before, or after, United Kingdom implementing legislation.  It would also apply if they were protected by old or new periods of data and market exclusivity.