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Obtaining access to unlicensed drugs.
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The Special Access Programme (SAP) 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

Special Access Program (SAP) web site

Prepared by the Food and Drug Administration, Office of Special Health Issues

Introduction The acronym "IND" refers to an Investigational New Drug application, which is an application to the Food and Drug Administration (FDA) to administer an investigational new drug or biologic product to humans. Since a biologic is also considered a drug, the term "drug" as used in this document refers to either a drug or a biologic product.

Most human use of investigational drugs takes place in clinical trials conducted to assess safety and efficacy of those drugs. Consequently, FDA's IND processes are designed primarily for drug companies and medical researchers engaged in clinical development of new drugs. However, some patients not eligible to participate in a clinical trial may benefit from treatment with an investigational drug under study. For such cases, FDA has developed numerous regulatory mechanisms to make investigational drugs available outside of clinical trials. These mechanisms include single-patient INDS, emergency INDS, and treatment INDs/protocols.

Single-Patient INDs and Emergency INDs
In many cases, the investigational drug will not be available through an expanded access program from the manufacturer. For such cases, the discussion below addresses how a physician can file a single-patient IND or an emergency IND for treatment of a patient with an investigational drug. In the case of a single-patient IND or an emergency IND, all of the following conditions must be met before FDA can allow a physician to administer an investigational drug under a single-patient or emergency IND:

a) The patient must be informed about the drug and consent to be treated with it.

b) The physician must be properly licensed and must agree to administer the product and be responsible for monitoring and reporting to FDA on the patient's use of the product (See forms 1571 and 1572.

c) The local Institutional Review Board (IRB) must approve the proposed use of the investigational drug (please note that in emergency situations it may be possible for the physician to notify the IRB promptly after treating the patient),

d) The manufacturer must be willing to provide the product without charge (unless the sponsor has applied for and FDA has allowed charges for cost recovery as provided for under Federal Regulations), and

e) FDA has allowed the transfer of the product from the manufacturer to the physician.

All Biological IND submissions must be made in triplicate and should be addressed as follows:

Center for Biologics Evaluation and Research
HFM-99, Room 200N
1401 Rockville Pike
Rockville, MD 20852-1448

Phone: 800-835-4709 or 301-827-1800

Additional information and and all forms may be obtained at the FDA's Center for Biologics Evaluation and Research (CBER) web site

Additional FDA information about the IND program can be found at
Investigational New Drug Application process

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.

Link to the above web page

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 0573
Fax: 020-7273 0595
E-mail: [email protected]

Medicines Control Agency main web site

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"

This part of the page is still under construction. If you have information on this programme for Australia please e-mail it to the webmaster at:  [email protected]