It is quite widely appreciated that the manufacture of many prescription medicines, particularly generics, is done outside the EEA and that most large generic companies have factories in lower cost production countries. What is less well recognised is the regulatory burden that is imposed upon applicants by the MHRA in order for applicants to obtain a product license for importing medicines into the UK that have been manufactured outside the EEA. To deal with this work the large generic manufacturers have in-house specialist teams of regulatory staff, whereas smaller generic companies would probably use contracted out regulatory staff.
The regulatory work required for each and every product to be put onto the UK/EU market as a licensed medicine is considerable and also the elapsed time from beginning work to obtaining a product license can easily exceed 12 months. As part of the product approvals process, the overseas manufacturing plant has to be inspected both by a Qualified person (QP) to ensure that all aspects of the manufacturing standards meet or exceed EEA standards, and also inspected by an MHRA inspector if the relevant manufacturing site has not previously been inspected.
Once the finished product reaches UK shores, a QP must arrange for samples to be taken and tested from each batch and only if the samples tested are satisfactory can the QP consider batch releasing the product onto the UK market.
As can be seen from the above, the process is lengthy and not without expense. Pharmacy Consulting Ltd has links with other organisations that can offer customers QP services, but the costs and time-scales of such work should not be underestimated