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Clinical
Trials > Expanded Access >
Special Access Program (Canada & UK)
Last update: 12/11/2004
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Canada | UK |
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Canada -
Provided
by Greg Dafoe
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The Special Access Programme has a mandate to provide access to non-marketed drugs to
practitioners treating patients with serious or life-threatening conditions when
conventional therapies have failed, are unsuitable, are unavailable or offer limited
options. Ultimately, SAP provides the authority for a manufacturer to sell a specific
quantity of a drug and therefore grant access to a drug which cannot be otherwise sold or
distributed in Canada. The scope of drugs considered for release by SAP includes
pharmaceutical, biologic, and radiopharmaceutical products that are not approved for sale
in Canada. SAP does not grant authority to use or administer a drug - this authority is
considered to be within the practice of medicine which is regulated at the provincial
level.
SAP authorization does not constitute an opinion or statement that a drug is safe,
efficacious or of high quality. SAP does not conduct a comprehensive evaluation to ensure
the validity of drug information or attestations of the manufacturer respecting safety,
efficacy and quality. These are important factors for practitioners to consider when
recommending the use of a drug and in making an appropriate risk/benefit decision in the
best interests of the patient. SAP strongly encourages practitioners treating patients
with drugs obtained through SAP to seek informed consent prior to treatment.
To initiate a request a practitioner may write, telephone,
fax or e-mail the Special
Access Programme:
Special Access Programme
Therapeutic Products Programme
Finance Building 2nd Floor
Tunney's Pasture
Ottawa, ON K1A 1B9
(613) 941-2108 (08:30-16:30 hours EST)
(613) 941-3194 (fax)
(613) 941-3061 (after-hours) Calls to this emergency service should be limited to
requests for drugs or blood products requiring immediate or overnight drug delivery.
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United Kingdom
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Medicines legislation (specifically The Medicines for Human Use (Marketing Authorisations
Etc.) Regulations 1994/SI 3144) requires that medicinal products are licensed before they
are marketed in the UK. However, some patients may have special clinical needs that cannot
be met by licensed medicinal products. So that these special needs may be met, the law
allows manufacture and supply of unlicensed medicinal products (commonly known as
"specials") subject to certain conditions.
The conditions are that there is a bona fide unsolicited order, the product is
formulated in accordance with the requirement of a doctor or dentist registered in the UK,
and the product is for use by their individual patients on their direct personal
responsibility. If a "special" is manufactured in the UK, the manufacturer must
hold a manufacturer's (specials) licence issued by the MCA. A "special" may not
be advertised and may not be supplied if an equivalent licensed product is available which
could meet the patient's needs. Essential records must be kept and serious adverse drug
reactions reported to the MCA.
Contact for further information
For further information about the manufacture and supply of "specials" for
individual patients, please contact the Policy Unit,
Inspection and Enforcement Division
17th floor, MCA Market Towers
1 Nine Elms Lane
Vauxhall, London SW8 5NQ
Telephone: 020-7273 0215
Fax: 020-7273 0676
E-mail: info@mca.gov.uk.
For specific information about "specials" Click on "Our work" on
the left, then click "Licensing of Medicines" on the right. Scroll down and
click on "Exemptions from licensing"
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