. /.WORLD TRADE
ORGANIZATIONG/TBT/N/GBR/4
20 September 2002
(02-5033)
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 Market Towers,
No.1 Nine Elms Lane, London, SW8 5NQ
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:   UK TBT Enquiry
Point, Department of Trade and Industry:
European communities TBT Enquiry Point ec-tbt@cec.eu.int
3. Notified under Article 2.9.2 [  X ], 2.10.1 [    ], 5.6.2 [ X ], 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 medicinal products
for human use which are supplied under UK law other than in accordance with a marketing
authorization under either Directive 2001/83/EC or the UK national scheme for regulatingmedicines not covered by the Community scheme, the Medicines Act 1968.
The two main categories of unlicensed medicines are:
(a)  medicines (commonly know as "specials") which are exempt from licensing because
they are supplied in response to the unsolicited order of a doctor or dentist to meet the
special needs of an individual patient on his direct personal responsibility;
(b)  medicines (excluding herbal remedies) mixed, assembled and supplied by someone who
is not a doctor or dentist, (known as a "non-orthodoyx practitioner"), to a patient who has
consulted him about his health.
In addition, any substance which, although not requiring a marketing authorization is
classified as a "medicinal product" with the united Kingdom, as is regulated accordingly.
5. Title, number of pages and language(s) of the notified document:
Draft Regulations, The Unlicensed ;Medicinal Products for Human Use (Transmissible
Spongiform Encephalopathies) (Safety) Regulations S.I. 2002
Number of pages:  11
Language:  EnglishG/TBT/N/GBR/4
Page 2
6. Description of content:   The proposed draft Regulations will prohibit the importation or
marketing of unlicensed medicinal products for human use, unless they have been
manufactured in accordance with the "Note for Guidance on Minimising the Risk of
Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products" as
published and updated by the European Commission.  There are exemptions for herbalremedies, products for clinical trials, and products produced by or under the supervision of a
pharmacist.  There is procedure for determining compliance with the Note for Guidance,
involving adjudication by an expert committee,  and designated record keepers in the United
Kingdom have to keep records of compliance.
7. Objective and rationale, including the na ture of urgent problems where applicable:
There is convincing evidence to show that a variant form of Creutzfeld-Jakob Disease,
which is responsible for a number of deaths in the United Kingdom, has been caused by an
Animal Spongiform Encephalopathy agent, BSE.  All licensed medicines in the UK are now
required to comply with this Note for Guidance.  UK Ministers now want to protect patientsfrom the same risk arising from unlicensed medicines.  As the Commission's TSE Guideline
states:  "... due prudence continues to be warranted if biological materials from species
affect by ... [Transmissible Spongiform Encephalopathy] diseases other than by
experimental challenge especially bovine species, are used for the manufacture of medicinal
products."
8. Relevant documents:
Draft Partial Regulatory Impact Assessment document.
Draft Regulations, The Unlicensed Medicinal Products for Human Use (Transmissible
Spongiform Encephalopathies) (Safety) Regulations S.I. 2002 ...
Note or Guidance on Minimising the Risk of Transmitting animal Spongiform
Encephalopathy Agents via Human Medicinal Products          
9. Proposed date of adoption:
Proposed date of entry into force: }The period of consultation in the U.K. ends on20 November 2002.  If after the comment
period, the Secretary of State for Healthdecides to proceed with the proposal, the likely
adoption date is some point in April 2003, with
a likely entry into force date at some point in
May 2003.          
10. Final date for comments:   9 December 2002
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:
UK TBT  Enquiry Point, Department of Tr ade and Industry, Kingsgate House, Bay 310,
66-74 Victoria Street, London, SW1E 6SW.   Email:  andy.weller@dti.gov.ukTel: +44 207 215 4548,   Fax: +44 207 215 4249