. /.WORLD TRADE
ORGANIZATIONG/TBT/N/GBR/6
13 December 2002
(02-6904)
Committee on Technical Barriers to Trade Original:   English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   UNITED KINGDOM
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Department of Health: Medicines Control Agency
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:   Department of
Trade and Industry TBTR Enquiry Point (see section 11);  European Commission TBT
Enquiry Point ec-tbt@cec.eu.int
3. Notified under Article 2.9.2 [  X ], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Medicines for human
use containing aspirin, paracetamol and more than 24mg of elemental iron.
5. Title, number of pages and language(s) of the notified document:   The Medicines (Child
Safety) Regulations 2003.  7 pages in English
6. Description of content:  These Regulations require aspirin, paracetamol and medicines
containing more than 24mg of elemental iron to be in child resistant containers. Non-reclosable containers will need to comply with a new British Standard, BS8404 – which is
based upon the proposed EN 14375 that should go to a vote in CEN in 2003 -, on nonreclosable packaging; and reclosable containers will need, as now, to comply with British
Standard BS EN 28317 – which is based upon the proposed ISO 8317  that should go to a
vote in ISO early 2003- on reclosable packaging. Pack sizes for these products exclusively
for children will be limited to 25. There are certain exemptions where doctors and dentists
direct otherwise. Solid dosage forms of aspirin and paracetamol will, as now, need to becoloured white. There are transitional arrangements that allow products already on the
market additional time to meet the new requirements.
7.Objective and rationale, including the na ture of urgent problems where applicable:
The requirements relating to colouring, and the pack size requirements for aspirin and
paracetamol in solid dosage form, have been in place since 1975. The requirements relating
to reclosable containers have been in place, in their present form, since 1994. All have
contributed to an important level of protection for children, who would otherwise be atgreater risk of dangerous overdose from these very widely available medicines. As regards
the requirements relating to non-reclosable packaging, the development of the new Standard
BS8404 for non-reclosable packaging, with industry co-operation, has provided the
opportunity to give children an equivalent level of protection from reclosable and non-
reclosable packaging. Extending the packaging requirements to medicines containing moreG/TBT/N/GBR/6
Page 2
than 24mg of elemental iron is to reduce the level of overdose of these medicines in
children, who are particularly vulnerable to comparatively low doses of these medicines,
which are frequently prescribed to mothers of young children. Applying the provisions to
liquid as well as oral formulations of paracetamol and elemental iron reflects the fact that
these present the same safety risk as the solid dosage forms.
8. Relevant documents:  The proposed new standard is British Standard BS 8404, but the
Regulations also re-enact measures applying another standard, British Standard EN 28317.
9. Proposed date of adoption:
Proposed date of entry into force: }April/May 2003
10. Final date for comments:   60 days
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
The draft text is available on line at the UK TBT Enquiry Point at
http://www.dti.gov.uk/worldtrade/barriers.htm
Department of Trade and Industry
UK TBT Enquiry Point
Kingsgate House, Bay 31066-74 Victoria Street
 London SW1E 6SW
Contact: Mr Andy Weller
e-mail andy.weller@dti.gsi.gov.uk
Tel ++ 44 201 215 4548
Fax ++44 207 215 4245