. /.  WORLD TRADE  
ORGANIZATION  G/TBT/N/GBR/11 
28 January 2004  
 
(04-0304) 
Committee on Technical Barriers to Trade Original:  English 
  
NOTIFICATION 
 
The following notification is being circ ulated 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):   N/A 
2. Agency responsible:   Department of Trade and Industry 
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:         
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):   Any unlicensed 
medicinal product consisting of or containing  any Senecio  species, other than those intended 
for external use only. 
5. Title, number of pages and language(s) of the notified document:   The Medicines for 
Human Use ( Senecio ) (Prohibition) Order 2004 (4 pages, in English) 
6. Description of content:   Under section 62(3) of the Medicines Act 1968, the proposed 
order will prohibit the sale, supply or importa tion of any unlicensed medicinal product for 
internal use which consists of or contains any  Senecio species in the United Kingdom, 
subject to the exceptions set out in article 3 of the draft order. 
7. Objective and rationale, including the nature of urgent problems where applicable:   In 
March 2002 it came to the attention of the Medicines and Healthcare products Regulatory 
Agency (MHRA) that a Ch inese medicinal product, Qian Bai Biyan Pian, which 
traditionally contains the toxic plant Senecio  scandens , had been placed on the UK market.  
Senecio scandens  is a member of the plant genus Senecio .  All species of plants within this 
genus contain unsaturated pyrrolizidine alkalo ids (PAs) which are known to cause serious 
liver damage, known as veno-occlusive disease in man.  Unsaturated pyrrolizidine alkaloids 
have also been shown to be carcinogenic,  mutagenic and genotoxic in animals.  
 In response to the risk to public health posed, the MHRA wrote to all herbal interest groups 
on 26 March 2002 highlighting the toxicity of the genus and requesting a voluntary 
withdrawal of all unlicensed medicines which may contain Senecio  species.  The Agency 
specifically asked to be made aware of any he rbal interest groups that disagreed with its 
initial safety assessment or proposed not to a dvise its members to remove any relevant 
products from supply.  No such representations were received.  However, the Agency has 
recently received a number of reports indicating that unlicensed herbal remedies which may 
contain Senecio  continue to be supplied to the public. 
On the basis of the available evidence, the MHRA considers any continued supply of 
Senecio in unlicensed medicines for internal  use poses a serious risk to public health. G/TBT/N/GBR/11 
Page 2  
 
In the interest of public safety, Ministers and the MHRA are now proposing to make an 
order prohibiting the sale, supply or importation of unlicensed medicinal products containing Senecio species.  
8. Relevant documents:   The Medicines for Human Use ( Senecio ) (Prohibition) Order 2004 
9. Proposed date of adoption:  - 
Proposed date of entry into force:  The period for consultation in the UK ends 
on 24 April 2004.  If, after the comment period and the advice from the Committee on the Safety of Medicines (CSM), the Secretary of  State for Health and the Northern Ireland 
Minister for Health, Social Services and Pub lic Safety consider the proposed prohibition to 
be necessary to protect public health, the prohi bition order will be made as soon as possible. 
10. Final date for comments:   30 April 2004 
11. Texts available from:  National enquiry point [    ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
Robert Box 
Bay 316 Europe and World Trade Directorate  Department of Trade and Industry 
Kingsgate House 
66-74 Victoria Street London SW1E 6SW  Tel: +44 (0)20 7215 4508 
Fax: +44 (0)20 7215 4249 
E-mail: robert.box@dti.gsi.gov.uk