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International Standard for Therapeutic Use Exemptions
The International Standard for Therapeutic Use Exemptions was first adopted in 2004
and became effective in 2005. The enclosed represents version 3.0 that incorporates
revisions to the International Standard for Therapeutic Use Exemptions that were approved by the World Anti-Doping Agency Executive Committee on 10 May and 20 September 2008. The revised International Standard for Therapeutic Use Exemptions is effective as of 1 January 2009. Published on 1 October 2008 by: World Anti-Doping Agency Stock Exchange Tower 800 Place Victoria (Suite 1700) PO Box 120 International Standard for Therapeutic Use Exemptions PREAMBLE
The World Anti-Doping Code International Standard for Therapeutic Use Exemptions (TUE) is a level 2 mandatory International Standard developed as part of the World Anti-Doping Program. The basis for the development of the International Standard for TUE has been a review of various procedures and protocols of International Federations, the IOC, National Anti-Doping Organizations and relevant sections in the revised International Standard for Doping Control (ISDC). A WADA expert reference group reviewed, discussed and prepared the document following wide consultation and consideration of submissions. The official text of the International Standard for Therapeutic Use Exemption shall be maintained by WADA and shall be published in English and French. In the event of any conflict between the English and French versions, the English version shall prevail. The International Standard for TUE (version 3.0) will come into effect on 1 January 2009. International Standard for Therapeutic Use Exemptions TABLE OF CONTENTS

PART ONE: INTRODUCTION, CODE
PROVISIONS AND DEFINITIONS. 5

3.2 Defined Terms from the International Standard for TUEs.12
PART TWO: STANDARDS FOR GRANTING THERAPEUTIC USE
EXEMPTIONS . 13

Criteria for Granting a Therapeutic Use Exemption .13 Therapeutic Use Exemption Committees (TUECs).15 Therapeutic Use Exemption (TUE) Application Process .15 8.0 Declaration of Use Process .18
ANNEX 1: . 20

Minimal requirements for the medical file to be used for the TUE process in the case of asthma and its clinical variants .20
ANNEX 2: . 21

Therapeutic use exemption application form.21 International Standard for Therapeutic Use Exemptions PART ONE: INTRODUCTION, CODE PROVISIONS AND
DEFINITIONS
Introduction and Scope
The purpose of the International Standard for TUE is to ensure that the process of granting therapeutic use exemptions is harmonized across sports and countries. The Code permits Athletes and their physicians to apply for therapeutic use exemptions (TUE) i.e. permission to use, for therapeutic purposes, substances or methods contained in the List of Prohibited Substances or Methods whose Use is otherwise prohibited. The International Standard for TUE includes criteria for granting a TUE, confidentiality of information, the formation of Therapeutic Use Exemptions Committees and the TUE application process. This Standard applies to all Athletes as defined by and subject to the Code i.e. able-bodied Athletes and Athletes with disabilities. The World Anti-Doping Program encompasses all of the elements needed in order to ensure optimal harmonization and best practice in international and national anti-doping programs. The main elements are: the Code (Level 1), International Standards (Level 2), and Models of Best Practice (Level 3). In the introduction to the Code, the purpose and implementation of the International Standards are summarized as follows: “International Standards for different technical and operational areas within the anti-doping program will be developed in consultation with the Signatories and governments and approved by WADA. The purpose of the International Standards is harmonization among Anti-Doping Organizations responsible for specific technical and operational parts of the anti-doping programs. Adherence to the International Standards is mandatory for compliance with the Code. The International Standards may be revised from time to time by the WADA Executive Committee after reasonable consultation with the Signatories and governments. Unless provided otherwise in the Code, International Standards and all revisions shall become effective on the date specified in the International Standard or revision.” Compliance with an International Standard (as opposed to another alternative standard, practice or procedure) shall be sufficient to conclude that the procedures covered by the International Standard were performed properly. Definitions specified in the Code are written in italics. Additional definitions specific to the International Standard for TUE are underlined. International Standard for Therapeutic Use Exemptions
2.0 Code Provisions
The following articles of the Code directly address the International Standard
for TUE:

Code Article 4.4 Therapeutic Use

WADA has adopted an International Standard for the process of granting therapeutic use exemptions. Each International Federation shall ensure, for International-Level Athletes or any other Athlete who is entered in an International Event, that a process is in place whereby Athletes with documented medical conditions requiring the Use of a Prohibited Substance or a Prohibited Method may request a therapeutic use exemption. Athletes who have been identified as included in their International Federation’s Registered Testing Pool may only obtain therapeutic use exemptions in accordance with the rules of their International Federation. Each International Federation shall publish a list of those International Events for which a therapeutic use exemption from the International Federation is required. Each National Anti-Doping Organization shall ensure, for all Athletes within its jurisdiction that have not been included in an International Federation Registered Testing Pool, that a process is in place whereby Athletes with documented medical conditions requiring the Use of a Prohibited Substance or a Prohibited Method may request a therapeutic use exemption. Such requests shall be evaluated in accordance with the International Standard for Therapeutic Use Exemptions. International Federations and National Anti-Doping Organizations shall promptly report to WADA through ADAMS the granting of any therapeutic use exemption except as regards national-level Athletes who are not included in the National Anti-Doping Organization's Registered Testing Pool. WADA, on its own initiative, may review at any time the granting of a therapeutic use exemption to any International-Level Athlete or national-level Athlete who is included in his or her National Anti-Doping Organization's Registered Testing Pool. Further, upon the request of any such Athlete who has been denied a therapeutic use exemption, WADA may review such denial. If WADA determines that such granting or denial of a therapeutic use exemption did not comply with the International Standard for Therapeutic Use Exemptions, WADA may reverse the decision. If, contrary to the requirement of this Article, an International Federation does not have a process in place where Athletes may request therapeutic use exemptions, an International-Level Athlete may request WADA to review the application as if it had been denied. Presence of a Prohibited Substance or its Metabolites or Markers (Article 2.1), Use or Attempted Use of a Prohibited Substance or a International Standard for Therapeutic Use Exemptions Prohibited Method (Article 2.2), Possession of Prohibited Substances and Prohibited Methods (Article 2.6) or Administration or Attempted Administration of a Prohibited Substance or Prohibited Method (Article 2.8) consistent with the provisions of an applicable therapeutic use exemption issued pursuant to the International Standard for Therapeutic Use Exemptions shall not be considered an anti-doping rule
Code Article 13.4 Appeals from Decisions Granting or Denying a
Therapeutic Use Exemption

Decisions by WADA reversing the grant or denial of a therapeutic use exemption may be appealed exclusively to CAS by the Athlete or the Anti-Doping Organization whose decision was reversed. Decisions by Anti-Doping Organizations other than WADA denying therapeutic use exemptions, which are not reversed by WADA, may be appealed by International-Level Athletes to CAS and by other Athletes to the national-level reviewing body described in Article 13.2.2. If the national-level reviewing body reverses the decision to deny a therapeutic use exemption, that decision may be appealed to CAS by WADA. When an Anti-Doping Organization fails to take action on a properly submitted therapeutic use exemption application within a reasonable time, the Anti-Doping Organization’s failure to decide may be considered a denial for purposes of the appeal rights provided in this Article.
Code
Article 14.5 Doping Control Information Clearinghouse
WADA shall act as a central clearinghouse for Doping Control Testing data and results for International-Level Athletes and national-level Athletes who have been included in their National Anti-Doping Organization's Registered Testing Pool. To facilitate coordinated test distribution planning and to avoid unnecessary duplication in Testing by the various Anti-Doping Organizations, each Anti-Doping Organization shall report all In-Competition and Out-of-Competition tests on such Athletes to the WADA clearinghouse as soon as possible after such tests have been conducted. This information will be made accessible to the Athlete, the Athlete's National Federation, National Olympic Committee or National Paralympic Committee, National Anti-Doping Organization, International Federation, and the International Olympic Committee or International Paralympic Committee. To enable it to serve as a clearinghouse for Doping Control Testing data, WADA has developed a database management tool, ADAMS, that reflects emerging data privacy principles. In particular, WADA has developed ADAMS to be consistent with data privacy statutes and norms applicable to WADA and other organizations using ADAMS. Private information regarding an Athlete, Athlete Support Personnel, or others involved in anti-doping activities shall be maintained by WADA, International Standard for Therapeutic Use Exemptions which is supervised by Canadian privacy authorities, in strict confidence and in accordance with the International Standard for the protection of privacy. WADA shall, at least annually, publish statistical reports summarizing the information that it receives, ensuring at all times that the privacy of Athletes is fully respected and make itself available for discussions with national and regional data privacy authorities.
Code Article 15.4 Mutual Recognition
15.4.1 Subject to the right to appeal provided in Article 13, Testing, therapeutic use exemptions and hearing results or other final adjudications of any Signatory which are consistent with the Code and are within that Signatory's authority, shall be recognized and respected by all other Signatories. [Comment to Article 15.4.1: There has in the past been some confusion in the interpretation of this Article with regard to therapeutic use exemptions. Unless provided otherwise by the rules of an International Federation or an agreement with an International Federation, National Anti-Doping Organizations do not have “authority” to grant therapeutic use exemptions to International-Level Athletes.] 15.4.2 Signatories shall recognize the same actions of other bodies which have not accepted the Code if the rules of those bodies are otherwise consistent with the Code. [Comment to Article 15.4.2: Where the decision of a body that has not accepted the Code is in some respects Code compliant and in other respects not Code compliant, Signatories should attempt to apply the decision in harmony with the principles of the Code. For example, if in a process consistent with the Code a non-Signatory has found an Athlete to have committed an anti-doping rule violation on account of the presence of a Prohibited Substance in his body but the period of Ineligibility applied is shorter than the period provided for in the Code, then all Signatories should recognize the finding of an anti-doping rule violation and the Athlete’s National Anti-Doping Organization should conduct a hearing consistent with Article 8 to determine whether the longer period of Ineligibility provided in the Code should be imposed.]
3.0 Terms and Definitions
3.1 Defined Terms from the Code


ADAMS
: The Anti-Doping Administration and Management System is a Web-
based database management tool for data entry, storage, sharing, and
reporting designed to assist stakeholders and WADA in their anti-doping
operations in conjunction with data protection legislation.
Adverse Analytical Finding: A report from a laboratory or other WADA-
approved entity that, consistent with the International Standard for
Laboratories and related Technical Documents, identifies in a Sample the presence of a Prohibited Substance or its Metabolites or Markers (including International Standard for Therapeutic Use Exemptions
elevated quantities of endogenous substances) or evidence of the Use of a
Prohibited Method.
Anti-Doping Organization: A Signatory that is responsible for adopting
rules for initiating, implementing or enforcing any part of the Doping Control
process. This includes, for example, the International Olympic Committee,
the International Paralympic Committee, other Major Event Organizations
that conduct Testing at their Events, WADA, International Federations, and
National Anti-Doping Organizations.
Athlete: Any Person who participates in sport at the international level (as
defined by each International Federation), the national level (as defined by each National Anti-Doping Organization, including but not limited to those Persons in its Registered Testing Pool), and any other competitor in sport who is otherwise subject to the jurisdiction of any Signatory or other sports organization accepting the Code. All provisions of the Code, including, for example, Testing and therapeutic use exemptions, must be applied to international- and national-level competitors. Some National Anti-Doping Organizations may elect to test and apply anti-doping rules to recreational-level or masters competitors who are not current or potential national caliber competitors. National Anti-Doping Organizations are not required, however, to apply all aspects of the Code to such Persons. Specific national rules may be established for Doping Control for non-international-level or non-national-level competitors without being in conflict with the Code. Thus, a country could elect to test recreational-level competitors but not require therapeutic use exemptions or whereabouts information. In the same manner, a Major Event Organization holding an Event only for masters-level competitors could elect to test the competitors but not require advance therapeutic use exemptions or whereabouts information. For purposes of Article 2.8 (Administration or Attempted Administration) and for purposes of anti-doping information and education, any Person who participates in sport under the authority of any Signatory, government, or other sports organization accepting the Code is an Athlete. [Comment: This definition makes it clear that all international- and national-caliber Athletes are subject to the anti-doping rules of the Code, with the precise definitions of international- and national-level sport to be set forth in the anti-doping rules of the International Federations and National Anti-Doping Organizations, respectively. At the national level, anti-doping rules adopted pursuant to the Code shall apply, at a minimum, to all persons on national teams and all persons qualified to compete in any national championship in any sport. That does not mean, however, that all such Athletes must be included in a National Anti-Doping Organization’s Registered Testing Pool. The definition also allows each National Anti-Doping Organization, if it chooses to do so, to expand its anti-doping program beyond national-caliber Athletes to competitors at lower levels of competition. Competitors at all levels of competition should receive the benefit of anti-doping information and education.]

Code:
The World Anti-Doping Code.

Competition: A single race, match, game or singular athletic contest. For
example, a basketball game or the finals of the Olympic 100-meter race in
International Standard for Therapeutic Use Exemptions

athletics. For stage races and other athletic contests where prizes are
awarded on a daily or other interim basis the distinction between a
Competition and an Event will be as provided in the rules of the applicable
International Federation.
Doping Control: All steps and processes from test distribution planning
through to ultimate disposition of any appeal including all steps and
processes in between such as provision of whereabouts information, Sample
collection and handling, laboratory analysis, therapeutic use exemptions,
results management and hearings.

Event:
A series of individual Competitions conducted together under one
ruling body (e.g., the Olympic Games, FINA World Championships, or Pan
American Games).
Event Period: The time between the beginning and end of an Event, as
established by the ruling body of the Event.
In-Competition: Unless provided otherwise in the rules of an International
Federation or other relevant Anti-Doping Organization, “In-Competition”
means the period commencing twelve hours before a Competition in which
the Athlete is scheduled to participate through the end of such Competition
and the Sample collection process related to such Competition.

International Event:
An Event where the International Olympic
Committee, the International Paralympic Committee, an International
Federation, a Major Event Organization, or another international sport
organization is the ruling body for the Event or appoints the technical officials
for the Event.

International-Level Athlete: Athletes designated by one or more
International Federations as being within the Registered Testing Pool for an
International Federation.
International Standard: A standard adopted by WADA in support of the
Code. Compliance with an International Standard (as opposed to another
alternative standard, practice or procedure) shall be sufficient to conclude that the procedures addressed by the International Standard were performed properly. International Standards shall include any Technical Documents issued pursuant to the International Standard. International Standard for Therapeutic Use Exemptions
National Anti-Doping Organization: The entity(ies) designated by each
country as possessing the primary authority and responsibility to adopt and
implement anti-doping rules, direct the collection of Samples, the
management of test results, and the conduct of hearings, all at the national
level. This includes an entity which may be designated by multiple countries
to serve as regional Anti-Doping Organization for such countries. If this
designation has not been made by the competent public authority(ies), the
entity shall be the country's National Olympic Committee or its designee.
National Event: A sport Event involving international- or national-level
Athletes that is not an International Event.

Out-of-Competition
: Any Doping Control which is not In-Competition.

Prohibited List
: The List identifying the Prohibited Substances and
Prohibited Methods.

Prohibited Method: Any method so described on the Prohibited List.
Prohibited Substance: Any substance so described on the Prohibited List.

Registered Testing Pool
: The pool of top-level Athletes established
separately by each International Federation and National Anti-Doping
Organization
who are subject to both In-Competition and Out-of-Competition
Testing as part of that International Federation's or National Anti-Doping
Organization
's test distribution plan. Each International Federation shall
publish a list which identifies those Athletes included in its Registered Testing
Pool either by name or by clearly defined, specific criteria.
Signatories: Those entities signing the Code and agreeing to comply with
the Code, including the International Olympic Committee, International
Federations, International Paralympic Committee, National Olympic
Committees, National Paralympic Committees, Major Event Organizations,
National Anti-Doping Organizations, and WADA.
Testing: The parts of the Doping Control process involving test distribution
planning, Sample collection, Sample handling, and Sample transport to the
laboratory.
Use: The utilization, application, ingestion, injection or consumption by any
means whatsoever of any Prohibited Substance or Prohibited Method.
WADA: The World Anti-Doping Agency.
International Standard for Therapeutic Use Exemptions
3.2 Defined Terms from the International Standard for TUEs
Retroactive TUE:
Therapeutic use exemption approved by a Therapeutic
Use Exemption Committee based on a documented medical file after a
laboratory has reported an Adverse Analytical Finding (AAF).
Therapeutic: Of or relating to the treatment of a medical condition by
remedial agents or methods; or providing or assisting in a cure.

TUE:
Therapeutic use exemption approved by a Therapeutic Use Exemption
Committee based on a documented medical file before the Use of the
substance in sports.

TUEC: Therapeutic Use Exemption Committee is the Panel established by the
relevant Anti-Doping Organization.

WADA TUEC: WADA Therapeutic Use Exemption Committee is the Panel
established by WADA.
International Standard for Therapeutic Use Exemptions PART TWO: STANDARDS FOR GRANTING
THERAPEUTIC USE EXEMPTIONS

4.0 Criteria for Granting a Therapeutic Use
Exemption
A therapeutic use exemption (TUE) may be granted to an Athlete permitting
the Use of a Prohibited Substance or Prohibited Method contained in the
Prohibited List. An application for a TUE will be reviewed by a Therapeutic
Use Exemption Committee (TUEC). The TUEC will be appointed by an Anti-Doping Organization. An exemption will be granted only in strict accordance with the following criteria: [Comment: This Standard can apply to all Athletes as defined by and subject to the Code, i.e. able-bodied Athletes and Athletes with disabilities. This Standard will be applied according to an individual’s circumstances. For example, an exemption that is appropriate for an Athlete with a disability may be inappropriate for other Athletes.] 4.1 The Athlete should submit an application for a TUE no less than
twenty-one (21) days before he/she needs the approval (for instance an Event). 4.2 The Athlete would experience a significant impairment to health if the
Prohibited Substance or Prohibited Method were to be withheld in the course
of treating an acute or chronic medical condition.
4.3 The therapeutic Use of the Prohibited Substance or Prohibited Method
would produce no additional enhancement of performance other than that
which might be anticipated by a return to a state of normal health following
the treatment of a legitimate medical condition. The Use of any Prohibited
Substance or Prohibited Method to increase “low-normal” levels of any endogenous hormone is not considered an acceptable therapeutic intervention. 4.4 There is no reasonable therapeutic alternative to the Use of the
otherwise Prohibited Substance or Prohibited Method.
4.5 The necessity for the Use of the otherwise Prohibited Substance or
Prohibited Method cannot be a consequence, wholly or in part, of prior non-
therapeutic Use of any substance from the Prohibited List.

4.6 The TUE will be cancelled by the granting body, if:
a. The Athlete does not promptly comply with any requirements or conditions imposed by the Anti-Doping Organization granting the b. The term for which the TUE was granted has expired. International Standard for Therapeutic Use Exemptions c. The Athlete is advised that the TUE has been withdrawn by the [Comment: Each TUE will have a specified duration as decided upon by the TUEC. There may be cases when a TUE has expired or has been withdrawn and the Prohibited Substance subject to the TUE is still present in the Athlete’s body. In such cases, the Anti-Doping Organization conducting the initial review of an adverse analytical finding will consider whether the finding is consistent with expiry or
withdrawal of the TUE.]
4.7 An application for a TUE will not be considered for retroactive approval
except in cases where:
a. Emergency treatment or treatment of an acute medical condition b. due to exceptional circumstances, there was insufficient time or opportunity for an applicant to submit, or a TUEC to consider, an application prior to Doping Control, or c. the conditions set forth under 7.13 apply. [Comment: Medical emergencies or acute medical situations requiring administration of an otherwise Prohibited Substance or Prohibited Method before an application for a TUE can be made, are uncommon. Similarly, circumstances requiring expedited consideration of an application for a TUE due to imminent competition are infrequent.
Anti-Doping Organizations granting
TUEs should have internal procedures which
permit such situations to be addressed.]

5.0. Confidentiality of Information

5.1 The applicant must provide written consent for the transmission of all
information pertaining to the application to members of the TUEC and, as required, other independent medical or scientific experts, or to all necessary staff involved in the management, review or appeal of TUEs. Should the assistance of external, independent experts be required, all details of the application will be circulated without identifying the Athlete
concerned. The applicant must also provide written consent for the decisions
of the TUEC to be distributed to other relevant Anti-Doping Organizations
under the provisions of the Code.
5.2 The members of the TUECs and the administration of the Anti-Doping
Organization involved will conduct all of their activities in strict confidence. All members of a TUEC and all staff involved will sign confidentiality agreements. In particular they will keep the following information confidential: International Standard for Therapeutic Use Exemptions a. All medical information and data provided by the Athlete and physician(s) involved in the Athlete’s care. b. All details of the application including the name of the physician(s) Should the Athlete wish to revoke the right of the TUEC or the WADA TUEC to obtain any health information on his/her behalf, the Athlete must notify his/her medical practitioner in writing of the fact. As a consequence of such a decision, the Athlete will not receive approval for a TUE or renewal of an existing TUE.
6.0 Therapeutic Use Exemption Committees (TUECs)

TUECs shall be constituted and act in accordance with the following
guidelines:

6.1 TUECs should include at least three (3) physicians with experience in
the care and treatment of Athletes and a sound knowledge of clinical, sports
and exercise medicine. In order to ensure a level of independence of
decisions, the majority of the members of any TUEC should be free of
conflicts of interest or political responsibility in the Anti-Doping Organization. All members of a TUEC will sign a conflict of interest agreement. In applications involving Athletes with disabilities, at least one TUEC member must possess specific experience with the care and treatment of Athletes with disabilities.
6.2 TUECs may seek whatever medical or scientific expertise they deem
appropriate in reviewing the circumstances of any application for a TUE.
6.3 The WADA TUEC shall be composed following the criteria set out in
Article 6.1. The WADA TUEC is established to review on its own initiative TUE decisions granted by Anti-Doping Organizations. As specified in Article 4.4 of the Code, the WADA TUEC, upon request by Athletes who have been denied TUEs by an Anti-Doping Organization, will review such decisions with the power to reverse them.

7.0 Therapeutic Use
Exemption (TUE) Application
Process

TUE will only be considered following the receipt of a completed application form that must include all relevant documents (see Annex 2 – TUE form). The application process must be dealt with in accordance with the principles of strict medical confidentiality. International Standard for Therapeutic Use Exemptions TUE application form(s), as set out in Annex 2, can be modified by Anti-Doping Organizations to include additional requests for information, but
no sections or items shall be removed.
7.3 The
TUE application form(s) may be translated into other language(s) by Anti-Doping Organizations, but English or French must remain on the application form(s).
7.4 An Athlete may not apply to more than one Anti-Doping Organization
for a TUE. The application must identify the Athlete’s sport and, where
appropriate, discipline and specific position or role.

7.5 The application must list any previous and/or current requests for
permission to use an otherwise Prohibited Substance or Prohibited Method,
the body to whom that request was made, and the decision of that body.
7.6 The application must include a comprehensive medical history and the
results of all examinations, laboratory investigations and imaging studies
relevant to the application. The arguments related to the diagnosis and
treatment, as well as duration of validity, should follow the WADA “Medical
Information to Support the Decisions of TUECs”. For asthma, the specific
requirement(s) set out in Annex 1 must be fulfilled.
7.7 Any additional relevant investigations, examinations or imaging studies
requested by the TUEC of the Anti-Doping Organization before approval will
be undertaken at the expense of the applicant or his/her national sport
governing body.

7.8 The application must include a statement by an appropriately qualified
physician attesting to the necessity of the otherwise Prohibited Substance or
Prohibited Method in the treatment of the Athlete and describing why an
alternative, permitted medication cannot, or could not, be used in the
treatment of this condition.
7.9 The dose, frequency, route and duration of administration of the
otherwise Prohibited Substance or Prohibited Method in question must be
specified. In case of change, a new application should be submitted.

7.10 In normal circumstances, decisions of the TUEC should be completed
within thirty (30) days of receipt of all relevant documentation and will be
conveyed in writing to the Athlete by the relevant Anti-Doping Organization.
In case of a TUE application made in a reasonable time limit prior to an Event
the TUEC should use its best endeavors to complete the TUE process before
the start of the Event. Where a TUE has been granted to an Athlete in the
Anti-Doping Organization Registered Testing Pool, the Athlete and WADA will
be provided promptly with an approval which includes information pertaining
to the duration of the exemption and any conditions associated with the TUE.
7.11 a. Upon receiving a request by an Athlete for review, the WADA TUEC
will, as specified in Article 4.4 of the Code, be able to reverse a decision on a
International Standard for Therapeutic Use Exemptions
TUE denied by an Anti-Doping Organization. The Athlete shall provide to the WADA TUEC all the information for a TUE as submitted initially to the Anti-Doping Organization accompanied by an application fee. Until the review process has been completed, the original decision remains in effect. The process should not take longer than thirty (30) days following receipt of all the information by WADA.
b. WADA can, on its own initiative, undertake a review at any time.
7.12 If the decision regarding the granting of a TUE is reversed by WADA
upon review, the reversal shall not apply retroactively and shall not disqualify
the Athlete's results during the period that the TUE had been granted and
shall take effect no later than fourteen (14) days following notification of the
decision to the Athlete.
7.13 The Use of inhaled Beta-2 Agonists:
- The Use of inhaled formoterol, salbutamol, salmeterol, terbutaline reflects current clinical practice. The Use of these substances should be declared on ADAMS where reasonably feasible and in accordance with the Code as soon as the product is used and must as well be declared on the Doping Control form at the time of Testing. Failure to declare will be taken into account in the result management process in particular in case of application for a Retroactive TUE. - Athletes using the substances listed above by inhalation must have a medical file justifying this Use and meeting the minimum requirements Depending upon the category of the Athlete, the medical file will
be evaluated as follows:

- For all Athletes included in an International Federation Registered
Testing Pool a regular TUE approved before the Use of the substance. - For Athletes participating in an International Event but who are not included in an International Federation Registered Testing Pool either a TUE, or a Retroactive TUE in the case of an Adverse Analytical Finding, in accordance with the rule of the International Federation or of the Major Event Organization. - For national-level Athletes who are not included in an International Federation Registered Testing Pool, whether or not they are part of a national Registered Testing Pool, either a TUE, or a Retroactive TUE in the case of an Adverse Analytical Finding, in accordance with the rules of the National Anti-Doping Organization. - No Retroactive TUE will be granted if the requirements of Annex 1 are not met meaning that any Adverse Analytical Finding reported by the International Standard for Therapeutic Use Exemptions laboratory in these circumstances will result in an anti-doping rule violation. - Any Athlete may apply for a TUE at any time if they wish. - Any Athlete who has applied for a TUE or a Retroactive TUE and who was denied such TUE may not use the substance without the prior granting of a TUE (no Retroactive TUE will be permitted).

8.0 Declaration of Use
Process

8.1 It is acknowledged that some substances included on the List of
Prohibited Substances
are used to treat medical conditions frequently
encountered in the athlete population. For monitoring purposes, these
substances, for which the route of administration is not prohibited, will
require a simple declaration of use. These are strictly limited to :

Glucocorticosteroids used by non systemic routes, namely intraarticular,
periarticular, peritendinous, epidural, intradermal injections and inhaled
route.
8.2 For the mentioned substances, the declaration of Use should be done
through ADAMS where reasonably feasible and in accordance with the Code
by the Athlete at the same time as the Use starts. This declaration should mention the diagnosis, the name of the substance, the dose undertaken, the name and the contact details of the physician.
In addition, the Athlete must declare the Use of the substance in question on
the Doping Control form.
9.0 Clearinghouse

9.1 Anti-Doping Organisations are required to provide WADA with all TUEs
approved for Athletes who are part of a national or international Registered
Testing Pool, and all supporting documentation, in accordance with section 7.
9.2 The declarations of use should be available to WADA (ADAMS).
9.3 The clearinghouse shall guarantee strict confidentiality of all the

10.0 Transitional provision

Abbreviated Therapeutic Use Exemptions (ATUEs) delivered prior to
December 31, 2008 shall remain governed by the 2005 TUE Standard.
These ATUEs shall remain valid after January 1, 2009 until the earliest of: International Standard for Therapeutic Use Exemptions (i) The date on which they are cancelled by the competent TUEC following review in accordance with art. 8.6 of the 2005 TUE Standard ; (ii) Their expiry date as mentioned on the ATUE ; (iii) December 31, 2009. International Standard for Therapeutic Use Exemptions
ANNEX 1:
Minimal requirements for the medical file to be used for the
TUE process in the case of asthma and its clinical variants

The file must reflect current best medical practice to include:
1)
A comprehensive report of the clinical examination with specific focus A report of spirometry with the measure of the Forced Expiratory Volume in 1 second (FEV1) If airway obstruction is present, the spirometry will be repeated after inhalation of a short acting Beta-2 Agonist to demonstrate the reversibility of bronchoconstriction 5) In the absence of reversible airway obstruction, a bronchial provocation test is required to establish the presence of airway hyper- Exact name, speciality, address (including telephone, e-mail, fax) of examining physician. International Standard for Therapeutic Use Exemptions
ANNEX 2:
Therapeutic use exemption application form
Identification of Anti-Doping Organization
Therapeutic Use Exemptions
Please complete all sections in capital letters or typing
1. Athlete Information
………………………………………….
Female ‰ Male ‰ Date of Birth(d/m/y)………………………………………
Address: …………………………………………………………………………………………
City: . Country: . Postcode: ………….
Tel.:…………………………………. ………………
………………………………………………………………….
(with international code)

Sport:……… . Discipline/Position: …………….
International or National Sport Organization:
……………………………………………………………………….

If athlete with disability, indicate disability: ………………………………………….
International Standard for Therapeutic Use Exemptions
2. Medical information
Diagnosis with sufficient medical information
(see note 1):
…………………………………………………………………………………………………………………………….
…………………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………………….
If a permitted medication can be used to treat the medical condition, provide clinical
justification for the requested use of the prohibited medication
……………………………………………………………………………………………………………………………………………………….
……………………………………………………………………………………………………………………………………………………….
……………………………………………………………………………………………………………………………………………………….
Prohibited substance(s):
Frequency
Generic name

Intended duration of
treatment:
(Please tick appropriate box) or duration (week/month): ………………………………… Have you submitted any previous TUE application: yes ‰ no ‰
For which substance?
…………………………………………………………………………………………………………………
whom?…………………………………………………………………….When?……………………………………………… Decision: Approved ‰ Not approved ‰ International Standard for Therapeutic Use Exemptions I certify that the above-mentioned treatment is medically appropriate and that the
use of alternative medication not on the prohibited list would be unsatisfactory for
this condition.


Name:…………………………………………………….
Medical specialty: …………………………………………………………………………………
Address: …………………………………………………………………
Tel.: …………………………………………………………………….
Fax: ………………………………………………………………….…
E-mail: …………………………………………………………………
Signature of Medical Practitioner: …………………………… Date: ……………….

5. Athlete’s declaration

I, …………………………………………………………………………………. certify that the information under 1. is accurate and that I am requesting approval to use a Substance or Method from the WADA Prohibited List. I authorize the release of personal medical information to the Anti-Doping Organization (ADO) as well as to WADA staff, to the WADA TUEC (Therapeutic Use Exemption Committee) and to other ADO under the provisions of the Code. I understand that if I ever wish to revoke the right of these organizations to obtain my health information on my behalf, I must notify my medical practitioner and my ADO in writing of that fact. Athlete’s signature: .
Date: …………….

Parent’s/Guardian’s signature: .

Date: …………….
(if the athlete is a minor or has a disability preventing him/her to sign this form, a parent or guardian shall sign together with or on behalf of the athlete)
International Standard for Therapeutic Use Exemptions
Note 1
Diagnosis
Evidence confirming the diagnosis must be attached and forwarded with this application. The medical evidence should include a comprehensive medical history and the results of all relevant examinations, laboratory investigations and imaging studies. Copies of the original reports or letters should be included when possible. Evidence should be as objective as possible in the clinical circumstances and in the case of non-demonstrable conditions independent supporting medical opinion will assist this application.
Incomplete Applications will be returned and will need to be
resubmitted.

Please submit the completed form to the ADO and keep a copy for your
records.
International Standard for Therapeutic Use Exemptions

Source: http://www.stv-fsg.ch/fileadmin/user_upload/stvfsgch/dokumente/ausbildung_gesundheit/praevention/antidoping/TUE_Standard_2009_Final_031008.pdf

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