Several new therapeutic classes to go OTC this year

Adults and children need OTC medicines |
By the end of the year pharmacists will be able to sell a number of medicines for conditions that have only previously been treatable with medicines prescribed by doctors.
The first of these — chloramphenicol eye drops (PJ, 4 December
2004, p803) — is expected next week but others are under consideration.
Kent Woods, chief executive of the Medicines and Healthcare products
Regulatory Agency, said in his foreword to the MHRA business plan for
2005–06 (PDF 370K) published last week: “The public need
medicines — and
indeed devices — over the counter, and children need medicines
suitable for them. We will do all we can to make more products available,
though without compromising the health of the public. We expect several
new therapeutic classes of medicines to become available during the year.”
The business plan reflects an expectation of increased workload at the
MHRA arising from last year’s EU expansion, particularly in relation
to the licensing of parallel imports.
“We expect the recent enlargement of the EU to result in applications
to import products from new member states, but we do not yet know to
what extent,” the plan says.
Workload in relation to the licensing of generic products is also expected
to rise.
“The large number of repeat use mutual recognition procedures (from
the UK into new member states) expected for the second half of 2004 did
not
materialise, but may do so in 2005 as generic product companies establish
commercial bases and markets in new member states.”
Licensing fees generally are to be frozen this year leading to a planned
operating deficit of £2.4m this year. |