Child-resistance proposals welcome

The long-awaited MCA proposals for the application of BS 8404 on the child resistance of non-reclosable pharmaceutical packaging have finally emerged as MLX 291. As anticipated in this column earlier in the year, the proposals will apply to those products containing aspirin, paracetamol, and iron (the latter above 24mg of elemental iron).

In the time allowed for consultation (the period ends on 18 February 2003) ABPI will consider the proposals carefully and will be submitting its response in due course.

There are a number of issues raised by the proposals which will require discussion and clarification. Among these outstanding matters are:

• Do the proposed Regulations allow 'type testing', i.e. the use of materials or material combinations previously tested? This is the system adopted in Germany in relation to application of the DIN standard and is an effective way of minimising the numbers of children subjected to the protocol.

• The proposed timescales for implementation need to be assessed. Given the number of licences involved and the dearth of facilities in the UK capable of carrying out the necessary testing, as well as the need to process license variations and potential retooling requirements, 12 months may be an optimistic estimate.

ABPI welcomes the publication of MCA's proposals and we will scrutinise them in detail and comment appropriately with a view to seeking a workable and effective legislative framework for implementation.