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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.
Main Health Canada Website
http://www.hc-sc.gc.ca/english
Special Access Program (SAP) web site
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.html
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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:
Medicines Control Agency main web site
http://www.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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