+---------------------------------------------------+------------------+
| Department of Health and Human Services           | ***Form          |
|                                                   | Approved***      |
| Food and Drug Administration                      |                  |
|                                                   | OMB Control      |
| **COMMON EMEA / FDA APPLICATION FOR**             | Number:          |
|                                                   |  0910-0167       |
| **ORPHAN MEDICINAL PRODUCT DESIGNATION**          |                  |
|                                                   | Expiration Date: |
|                                                   |  May 31, 2008    |
+---------------------------------------------------+------------------+
|                                                   | *See OMB         |
|                                                   | Statement on     |
|                                                   | final page.*     |
+---------------------------------------------------+------------------+
| The sponsor of a medicinal product^1^ for human   |                  |
| use may desire to seek orphan designation of its  |                  |
| medicinal product for use to diagnose, treat, or  |                  |
| prevent a rare disease or condition from the      |                  |
| European Commission in accordance with Regulation |                  |
| (EC) No 141/2000 of 16 December 1999 and          |                  |
| Commission Regulation (EC) No 847/2000, and from  |                  |
| the United States Food and Drug Administration    |                  |
| (FDA) in accordance with section 526 of the       |                  |
| Federal Food, Drug, and Cosmetic Act (FDCA) (21   |                  |
| U.S.C. 360bb). In such case, the sponsor may      |                  |
| apply for orphan designation of the same          |                  |
| medicinal product for the same use in both        |                  |
| jurisdictions by using this common application    |                  |
| form for its submissions to the European          |                  |
| Medicines Agency (EMEA) and the FDA.              |                  |
|                                                   |                  |
| The application may be submitted to the European  |                  |
| Medicines Agency (EMEA)^2^ and to the FDA Office  |                  |
| of Orphan Products Development.^3^                |                  |
+---------------------------------------------------+------------------+
| **Note:** The sponsor should consult the          |                  |
| 'Guideline for the format and content of          |                  |
| applications for designation as orphan medicinal  |                  |
| products' (ENTR/6283/00) when completing the      |                  |
| application to EMEA. Relevant sections defined in |                  |
| this Guideline must be submitted to EMEA. An      |                  |
| application^4^ submitted to FDA must comply with  |                  |
| 21 U.S.C. 360bb and 21 CFR Part 316 *et seq*.,    |                  |
| irrespective of whether this form is used.        |                  |
|                                                   |                  |
| > The sponsor must submit one original in paper   |                  |
| > (signed and dated) and two electronic copies to |                  |
| > EMEA. FDA requires either two paper copies of   |                  |
| > the application or it may be submitted via      |                  |
| > electronic format through the use of physical   |                  |
| > media (see 'Draft Guidance for Industry:        |                  |
| > Providing Regulatory Submissions in Electronic  |                  |
| > Format for Orphan Drug and Humanitarian Use     |                  |
| > Device Designation Requests and Related         |                  |
| > Submissions').^5^                               |                  |
+---------------------------------------------------+------------------+
| **THIS APPLICATION CONCERNS** *(Please check the  |                  |
| appropriate item.)*                               |                  |
|                                                   |                  |
| > **An active substance not currently             |                  |
| > authorised^ 6,7^**                              |                  |
| >                                                 |                  |
| > **An active substance currently authorised for  |                  |
| > another indication**                            |                  |
| >                                                 |                  |
| > **A potentially clinically superior medicinal   |                  |
| > product containing the same active substance as |                  |
| > one in an already authorised medicinal product  |                  |
| > for the same orphan use (for application to FDA |                  |
| > only)**                                         |                  |
+---------------------------------------------------+------------------+
| **Note:** The sponsor may apply for orphan        |                  |
| designation of a previously unapproved medicinal  |                  |
| product, or an already authorised medicinal       |                  |
| product for a new orphan indication. The sponsor  |                  |
| may also seek and obtain orphan designation of a  |                  |
| medicinal product containing the same active      |                  |
| substance as one in an already authorised         |                  |
| medicinal product from FDA, if it can present a   |                  |
| plausible hypothesis of clinical superiority. The |                  |
| sponsor must append information to support such   |                  |
| hypothesis to this application.^8^ In the         |                  |
| application to EMEA, if the sponsor is the holder |                  |
| of an existing marketing authorisation in the     |                  |
| European Community for this product, the sponsor  |                  |
| should provide details of the currently           |                  |
| authorised indication(s) and the type of          |                  |
| marketing authorisation granted. *(Note           |                  |
| continued, page 2)*                               |                  |
+---------------------------------------------------+------------------+
| ^1^ The term "medicinal product" is used in this  |                  |
| document in place of the word "drug" used in the  |                  |
| FDA Orphan Drug Regulations (21 CFR Part 316)     |                  |
| without any intention to alter its regulatory     |                  |
| meaning.                                          |                  |
|                                                   |                  |
| ^2^ See http://www.emea.europa.eu/                |                  |
|                                                   |                  |
| ^3^ See http://www.fda.gov/orphan/                |                  |
|                                                   |                  |
| ^4^ The word "application" is used in this        |                  |
| document in place of the word "request" used in   |                  |
| the FDA Orphan Drug regulations without any       |                  |
| intention to alter its regulatory meaning.        |                  |
|                                                   |                  |
| ^5^ See http://www.fda.gov/orphan/esub/esub.htm   |                  |
|                                                   |                  |
| ^6^ The term "active substance" is used in this   |                  |
| document in place of the term "active moiety" (if |                  |
| the medicinal product is a small molecule), and   |                  |
| "principal molecular structural features" (if the |                  |
| medicinal product is a large molecule) as used in |                  |
| the FDA Orphan Drug Regulations without any       |                  |
| intention to alter their regulatory meaning.      |                  |
|                                                   |                  |
| ^7^ The word "authorised" is used in this         |                  |
| document in place of the word "approved" used in  |                  |
| the FDA Orphan Drug Regulations without any       |                  |
| intention to alter its regulatory meaning.        |                  |
|                                                   |                  |
| ^8^ See §§ 316.20(a) and 316.20(b)(5) for         |                  |
| application to FDA.                               |                  |
+---------------------------------------------------+------------------+

+---+--------------------------+-----------------------------------------+
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+---+--------------------------+-----------------------------------------+
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+---+--------------------------+-----------------------------------------+
|   | **Note:** The sponsor    |                                         |
|   | must append              |                                         |
|   | documentation, with      |                                         |
|   | authoritative            |                                         |
|   | references, to           |                                         |
|   | demonstrate that the     |                                         |
|   | number of people         |                                         |
|   | affected by the disease  |                                         |
|   | or condition in the      |                                         |
|   | European Union           |                                         |
|   | (application to EMEA),   |                                         |
|   | or United States         |                                         |
|   | (application to FDA)     |                                         |
|   | meets the respective     |                                         |
|   | statutory prevalence     |                                         |
|   | threshold. The sponsor   |                                         |
|   | must include a           |                                         |
|   | description of the       |                                         |
|   | methodology used for     |                                         |
|   | gathering the data, data |                                         |
|   | sources (including dates |                                         |
|   | of information provided  |                                         |
|   | and literature sources), |                                         |
|   | calculations, and        |                                         |
|   | results of these         |                                         |
|   | calculations.^10^        |                                         |
|   |                          |                                         |
|   | The sponsor must comply  |                                         |
|   | with section B on        |                                         |
|   | 'Prevalence of the       |                                         |
|   | condition' of Guideline  |                                         |
|   | ENTR/6283/00             |                                         |
|   | (application to EMEA),   |                                         |
|   | and 21 CFR §§ 316.20(b)  |                                         |
|   | and 316.21 (application  |                                         |
|   | to FDA) when completing  |                                         |
|   | this section.            |                                         |
+---+--------------------------+-----------------------------------------+
|   | Potential for lack of    |                                         |
|   | return on investment/no  |                                         |
|   | reasonable expectation   |                                         |
|   | of cost recovery         |                                         |
+---+--------------------------+-----------------------------------------+
|   | **Note:** The sponsor    |                                         |
|   | must append              |                                         |
|   | documentation, with      |                                         |
|   | authoritative            |                                         |
|   | references, to           |                                         |
|   | demonstrate that,        |                                         |
|   | without incentives,      |                                         |
|   | there is no reasonable   |                                         |
|   | expectation that costs   |                                         |
|   | of research and          |                                         |
|   | development of the       |                                         |
|   | medicinal product for    |                                         |
|   | the orphan indication    |                                         |
|   | can be recovered if the  |                                         |
|   | medicinal product is     |                                         |
|   | authorised for marketing |                                         |
|   | in the European          |                                         |
|   | Community (application   |                                         |
|   | to EMEA) or in the       |                                         |
|   | United States            |                                         |
|   | (application to          |                                         |
|   | FDA).^11^ For            |                                         |
|   | application to EMEA, the |                                         |
|   | sponsor should also      |                                         |
|   | include information      |                                         |
|   | showing it is unlikely   |                                         |
|   | that the marketing of    |                                         |
|   | the medicinal product in |                                         |
|   | the European Community   |                                         |
|   | would generate           |                                         |
|   | sufficient return to     |                                         |
|   | justify the necessary    |                                         |
|   | investment.              |                                         |
|   |                          |                                         |
|   | The sponsor must comply  |                                         |
|   | with section C on        |                                         |
|   | 'Potential for return on |                                         |
|   | investment' of Guideline |                                         |
|   | ENTR/6283/00             |                                         |
|   | (application to EMEA),   |                                         |
|   | and 21 CFR §§ 316.20(b), |                                         |
|   | 316.21(c) and (d)        |                                         |
|   | (application to FDA)     |                                         |
|   | when completing this     |                                         |
|   | section.                 |                                         |
+---+--------------------------+-----------------------------------------+
|   |                          |                                         |
+---+--------------------------+-----------------------------------------+
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| * |                          |                                         |
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+---+--------------------------+-----------------------------------------+
|   |                          |                                         |
+---+--------------------------+-----------------------------------------+
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| c |                          |                                         |
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| t |                          |                                         |
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| n |                          |                                         |
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| . |                          |                                         |
+---+--------------------------+-----------------------------------------+

+---+--------------------------+-----------------------------------------+
|   |                          |                                         |
+---+--------------------------+-----------------------------------------+
|   | **Note:** In the         |                                         |
|   | application to EMEA, the |                                         |
|   | sponsor should indicate  |                                         |
|   | whether the name         |                                         |
|   | provided is the          |                                         |
|   | proposed/accepted        |                                         |
|   | International            |                                         |
|   | Nonproprietary Name,     |                                         |
|   | European Pharmacopoeia   |                                         |
|   | name, National           |                                         |
|   | Pharmacopoeia, official  |                                         |
|   | compendial name, common  |                                         |
|   | name, or scientific      |                                         |
|   | name. In the application |                                         |
|   | to FDA, the sponsor      |                                         |
|   | should provide the       |                                         |
|   | generic name (such as    |                                         |
|   | the United States        |                                         |
|   | Adopted Name             |                                         |
|   | Council-approved name)   |                                         |
|   | and trade name, if any,  |                                         |
|   | of the medicinal         |                                         |
|   | product.^12^             |                                         |
|   |                          |                                         |
|   | The proposed/accepted    |                                         |
|   | trade name in the        |                                         |
|   | European Community, the  |                                         |
|   | Anatomical Therapeutic   |                                         |
|   | Chemical code, the       |                                         |
|   | proposed strength,       |                                         |
|   | pharmaceutical form, and |                                         |
|   | route of administration  |                                         |
|   | for the medicinal        |                                         |
|   | product, if available,   |                                         |
|   | should also be included  |                                         |
|   | in the application to    |                                         |
|   | EMEA, but they are not   |                                         |
|   | required in the          |                                         |
|   | application to FDA (see  |                                         |
|   | 21 CFR § 316.20(b)).     |                                         |
+---+--------------------------+-----------------------------------------+
|   |                          |                                         |
+---+--------------------------+-----------------------------------------+
| * |                          |                                         |
| * |                          |                                         |
| 3 |                          |                                         |
| ) |                          |                                         |
| P |                          |                                         |
| r |                          |                                         |
| o |                          |                                         |
| p |                          |                                         |
| o |                          |                                         |
| s |                          |                                         |
| e |                          |                                         |
| d |                          |                                         |
| O |                          |                                         |
| r |                          |                                         |
| p |                          |                                         |
| h |                          |                                         |
| a |                          |                                         |
| n |                          |                                         |
| D |                          |                                         |
| e |                          |                                         |
| s |                          |                                         |
| i |                          |                                         |
| g |                          |                                         |
| n |                          |                                         |
| a |                          |                                         |
| t |                          |                                         |
| i |                          |                                         |
| o |                          |                                         |
| n |                          |                                         |
| * |                          |                                         |
| * |                          |                                         |
+---+--------------------------+-----------------------------------------+
|   | **Note:** The sponsor    |                                         |
|   | must append a            |                                         |
|   | description of the rare  |                                         |
|   | disease or condition for |                                         |
|   | which the medicinal      |                                         |
|   | product is being or will |                                         |
|   | be investigated, and the |                                         |
|   | reasons why such therapy |                                         |
|   | is needed.^13^ If more   |                                         |
|   | than one designation is  |                                         |
|   | applied for, the sponsor |                                         |
|   | should submit a separate |                                         |
|   | application for each     |                                         |
|   | designation (e.g., one   |                                         |
|   | application for the      |                                         |
|   | treatment indication and |                                         |
|   | one application for the  |                                         |
|   | prevention indication of |                                         |
|   | the medicinal product    |                                         |
|   | for the rare disease or  |                                         |
|   | condition). If the       |                                         |
|   | medicinal product is     |                                         |
|   | under development for    |                                         |
|   | only a subset of persons |                                         |
|   | with a disease or        |                                         |
|   | condition, the sponsor   |                                         |
|   | must demonstrate the     |                                         |
|   | medical plausibility why |                                         |
|   | the remaining persons    |                                         |
|   | with the same disease or |                                         |
|   | condition are not        |                                         |
|   | appropriate candidates   |                                         |
|   | for use of the medicinal |                                         |
|   | product.^14^             |                                         |
|   |                          |                                         |
|   | The sponsor must also    |                                         |
|   | append a discussion on   |                                         |
|   | the rationale for the    |                                         |
|   | use of the medicinal     |                                         |
|   | product for the rare     |                                         |
|   | disease or condition in  |                                         |
|   | question. All relevant   |                                         |
|   | supportive information   |                                         |
|   | from non-clinical        |                                         |
|   | studies, clinical        |                                         |
|   | investigations, and      |                                         |
|   | other evidence available |                                         |
|   | to the sponsor, whether  |                                         |
|   | positive, negative, or   |                                         |
|   | inconclusive, must be    |                                         |
|   | submitted.^15^           |                                         |
|   |                          |                                         |
|   | The sponsor must comply  |                                         |
|   | with section A on        |                                         |
|   | 'Description of the      |                                         |
|   | condition' of Guideline  |                                         |
|   | ENTR/6283/00             |                                         |
|   | (application to EMEA),   |                                         |
|   | and 21 CFR § 316.20(b)   |                                         |
|   | (application to FDA)     |                                         |
|   | when completing this     |                                         |
|   | section.                 |                                         |
+---+--------------------------+-----------------------------------------+
|   |                          |                                         |
+---+--------------------------+-----------------------------------------+
| * |                          |                                         |
| * |                          |                                         |
| 4 |                          |                                         |
| ) |                          |                                         |
| S |                          |                                         |
| u |                          |                                         |
| m |                          |                                         |
| m |                          |                                         |
| a |                          |                                         |
| r |                          |                                         |
| y |                          |                                         |
| o |                          |                                         |
| f |                          |                                         |
| D |                          |                                         |
| e |                          |                                         |
| v |                          |                                         |
| e |                          |                                         |
| l |                          |                                         |
| o |                          |                                         |
| p |                          |                                         |
| m |                          |                                         |
| e |                          |                                         |
| n |                          |                                         |
| t |                          |                                         |
| S |                          |                                         |
| t |                          |                                         |
| a |                          |                                         |
| t |                          |                                         |
| u |                          |                                         |
| s |                          |                                         |
| a |                          |                                         |
| n |                          |                                         |
| d |                          |                                         |
| R |                          |                                         |
| e |                          |                                         |
| g |                          |                                         |
| u |                          |                                         |
| l |                          |                                         |
| a |                          |                                         |
| t |                          |                                         |
| o |                          |                                         |
| r |                          |                                         |
| y |                          |                                         |
| H |                          |                                         |
| i |                          |                                         |
| s |                          |                                         |
| t |                          |                                         |
| o |                          |                                         |
| r |                          |                                         |
| y |                          |                                         |
| * |                          |                                         |
| * |                          |                                         |
+---+--------------------------+-----------------------------------------+
|   | **Note:** The sponsor    |                                         |
|   | must append a summary of |                                         |
|   | the world-wide           |                                         |
|   | regulatory status and    |                                         |
|   | marketing history of the |                                         |
|   | medicinal product to     |                                         |
|   | include, where           |                                         |
|   | applicable, current      |                                         |
|   | investigational uses,    |                                         |
|   | previous marketing       |                                         |
|   | approvals, orphan        |                                         |
|   | status, and adverse      |                                         |
|   | regulatory actions, if   |                                         |
|   | any, in any country.^16^ |                                         |
|   |                          |                                         |
|   | The sponsor must comply  |                                         |
|   | with section E on        |                                         |
|   | 'Description of the      |                                         |
|   | stage of development' of |                                         |
|   | Guideline ENTR/6283/00   |                                         |
|   | (application to EMEA),   |                                         |
|   | and 21 CFR §             |                                         |
|   | 316.20(b)(7)             |                                         |
|   | (application to FDA)     |                                         |
|   | when completing this     |                                         |
|   | section.                 |                                         |
+---+--------------------------+-----------------------------------------+
|   |                          |                                         |
+---+--------------------------+-----------------------------------------+
|   |                          |                                         |
+---+--------------------------+-----------------------------------------+
| ^ |                          |                                         |
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+---+--------------------------+-----------------------------------------+

+---+-----------------------------------+--------------------------------+
| * |                                   |                                |
| * |                                   |                                |
| 5 |                                   |                                |
| ) |                                   |                                |
| I |                                   |                                |
| n |                                   |                                |
| f |                                   |                                |
| o |                                   |                                |
| r |                                   |                                |
| m |                                   |                                |
| a |                                   |                                |
| t |                                   |                                |
| i |                                   |                                |
| o |                                   |                                |
| n |                                   |                                |
| o |                                   |                                |
| n |                                   |                                |
| t |                                   |                                |
| h |                                   |                                |
| e |                                   |                                |
| S |                                   |                                |
| p |                                   |                                |
| o |                                   |                                |
| n |                                   |                                |
| s |                                   |                                |
| o |                                   |                                |
| r |                                   |                                |
| * |                                   |                                |
| * |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | NAME / CORPORATE NAME             |                                |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | CONTACT PERSON / TITLE            |                                |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | ADDRESS                           | TELEPHONE                      |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   |                                   | TELEFAX                        |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   |                                   | E-MAIL                         |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | COUNTRY                           |                                |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | **Note:** In the application to   |                                |
|   | FDA, information on telefax and   |                                |
|   | e-mail is optional.               |                                |
+---+-----------------------------------+--------------------------------+
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
| * |                                   |                                |
| * |                                   |                                |
| 6 |                                   |                                |
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| d |                                   |                                |
| i |                                   |                                |
| f |                                   |                                |
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| n |                                   |                                |
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| f |                                   |                                |
| r |                                   |                                |
| o |                                   |                                |
| m |                                   |                                |
| ­  |                                   |                                |
| s |                                   |                                |
| e |                                   |                                |
| c |                                   |                                |
| t |                                   |                                |
| i |                                   |                                |
| o |                                   |                                |
| n |                                   |                                |
| 5 |                                   |                                |
| ) |                                   |                                |
| * |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | NAME / CORPORATE NAME             |                                |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | CONTACT PERSON / TITLE            |                                |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | ADDRESS                           | TELEPHONE                      |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   |                                   | TELEFAX                        |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   |                                   | E-MAIL                         |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | COUNTRY                           |                                |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | **Note:** The sponsor should      |                                |
|   | append a letter authorising the   |                                |
|   | named entity to communicate on    |                                |
|   | behalf of the sponsor, if         |                                |
|   | applicable. Please note that in   |                                |
|   | the application to EMEA, for      |                                |
|   | sponsors whose main business is   |                                |
|   | operated from outside the         |                                |
|   | European Economic Area (EEA) an   |                                |
|   | EEA-established person, or a      |                                |
|   | company, as a contact person for  |                                |
|   | communication should be provided. |                                |
|   | A proof of establishment in the   |                                |
|   | EEA should be provided in any     |                                |
|   | case. In the application to FDA,  |                                |
|   | a non-United States sponsor must  |                                |
|   | name a permanent resident in the  |                                |
|   | United States as the sponsor's    |                                |
|   | agent together with his/her       |                                |
|   | address, through whom all         |                                |
|   | communications will be made on    |                                |
|   | behalf of the sponsor as required |                                |
|   | in 21 CFR § 316.22.               |                                |
+---+-----------------------------------+--------------------------------+

+---+--------------------------+--------+--------------------------------+
| * |                          |        |                                |
| * |                          |        |                                |
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| s |                          |        |                                |
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| : |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   | NAME / CORPORATE NAME    |        |                                |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   | CONTACT PERSON / TITLE   |        |                                |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   | ADDRESS                  |        | TELEPHONE                      |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   |                          |        | TELEFAX                        |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   |                          |        | E-MAIL                         |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   | COUNTRY                  |        |                                |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
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+---+--------------------------+--------+--------------------------------+
|   | NAME / CORPORATE NAME    |        |                                |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   | CONTACT PERSON / TITLE   |        |                                |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   | ADDRESS                  |        | TELEPHONE                      |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   |                          |        | TELEFAX                        |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   |                          |        | E-MAIL                         |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   | COUNTRY                  |        |                                |
|   |                          |        |                                |
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
|   | **Note:** For products   |        |                                |
|   | that are in the early    |        |                                |
|   | stages of development it |        |                                |
|   | may not be possible to   |        |                                |
|   | provide the above        |        |                                |
|   | information. In          |        |                                |
|   | application to FDA, only |        |                                |
|   | the name and address of  |        |                                |
|   | the source of the active |        |                                |
|   | substance is required,   |        |                                |
|   | if it is not             |        |                                |
|   | manufactured by the      |        |                                |
|   | sponsor.^17^             |        |                                |
+---+--------------------------+--------+--------------------------------+
|   |                          |        |                                |
+---+--------------------------+--------+--------------------------------+
| ^ |                          |        |                                |
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+---+--------------------------+--------+--------------------------------+

+---+---------------------------------------------------------------------+
| * |                                                                     |
| * |                                                                     |
| A |                                                                     |
| D |                                                                     |
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| / |                                                                     |
| 2 |                                                                     |
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| 4 |                                                                     |
| ) |                                                                     |
+---+---------------------------------------------------------------------+
|   | TRADE NAME                                                          |
|   |                                                                     |
|   |                                                                     |
+---+---------------------------------------------------------------------+
|   | DATE OF AUTHORISATION *(mm/dd/yyyy)*                                |
|   |                                                                     |
|   |                                                                     |
+---+---------------------------------------------------------------------+
|   | MARKETING AUTHORISATION NUMBER(S)                                   |
|   |                                                                     |
|   |                                                                     |
+---+---------------------------------------------------------------------+
|   | MARKETING AUTHORISATION HOLDER                                      |
|   |                                                                     |
|   |                                                                     |
+---+---------------------------------------------------------------------+
|   | b) Mutual recognition (in accordance with Article 28 of Directive   |
|   | 2001/83/EC)                                                         |
+---+---------------------------------------------------------------------+
|   | REFERENCE MEMBER STATE                                              |
|   |                                                                     |
|   |                                                                     |
+---+---------------------------------------------------------------------+
|   | DATE OF AUTHORISATION *(mm/dd/yyyy)*                                |
|   |                                                                     |
|   |                                                                     |
+---+---------------------------------------------------------------------+
|   | MARKETING AUTHORISATION HOLDER                                      |
|   |                                                                     |
|   |                                                                     |
+---+---------------------------------------------------------------------+
|   | CONCERNED MEMBER STATE(S) *(Please check applicable.)*              |
|   |                                                                     |
|   | AT BE BG CY CZ DE DK EE EL ES                                       |
|   |                                                                     |
|   | FI FR HU IS IE IT LI LT LU LV                                       |
|   |                                                                     |
|   | MT NL NO PL PT RO SE SI SK UK                                       |
+---+---------------------------------------------------------------------+
|   | **Note:** Please attach details of trade name(s) and marketing      |
|   | authorisation number(s).                                            |
+---+---------------------------------------------------------------------+

+---+---------------------------------------------------------------------+
|   | c) National procedure                                               |
+---+---------------------------------------------------------------------+
|   | DATE OF AUTHORISATION *(mm/dd/yyyy)*                                |
|   |                                                                     |
|   |                                                                     |
+---+---------------------------------------------------------------------+
|   | MARKETING AUTHORISATION HOLDER                                      |
|   |                                                                     |
|   |                                                                     |
+---+---------------------------------------------------------------------+
|   | MEMBER STATE(S) WHERE AUTHORISED *(Please check applicable)*        |
|   |                                                                     |
|   | AT BE BG CY CZ DE DK EE EL ES                                       |
|   |                                                                     |
|   | FI FR HU IS IE IT LI LT LU LV                                       |
|   |                                                                     |
|   | MT NL NO PL PT RO SE SI SK UK                                       |
+---+---------------------------------------------------------------------+
|   | **Note:** Please attach details of trade name(s) and marketing      |
|   | authorisation number(s).                                            |
+---+---------------------------------------------------------------------+
|   |                                                                     |
+---+---------------------------------------------------------------------+
| * |                                                                     |
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| x |                                                                     |
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| t |                                                                     |
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| c |                                                                     |
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| m |                                                                     |
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| t |                                                                     |
| y |                                                                     |
+---+---------------------------------------------------------------------+
|   | **Note:** For the documentation submitted in support of this        |
|   | application, section D(1) of Guideline ENTR/6283/00 should contain  |
|   | a statement that no other methods currently exist.                  |
+---+---------------------------------------------------------------------+
|   | Other methods exist but are not considered satisfactory             |
+---+---------------------------------------------------------------------+
|   | **Note:** For the documentation submitted in support of this        |
|   | application, sections D(1) and D(2) of Guideline ENTR/6283/00       |
|   | should be completed.                                                |
+---+---------------------------------------------------------------------+
|   | Other satisfactory methods exist but this medicinal product will be |
|   | of significant benefit to those affected by the condition           |
+---+---------------------------------------------------------------------+
|   | **Note:** For the documentation submitted in support of this        |
|   | application, sections D(1) and D(3) of Guideline ENTR/6283/00       |
|   | should be completed.                                                |
+---+---------------------------------------------------------------------+
|   |                                                                     |
+---+---------------------------------------------------------------------+
| * |                                                                     |
| * |                                                                     |
| 3 |                                                                     |
| ) |                                                                     |
| A |                                                                     |
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| t |                                                                     |
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| f |                                                                     |
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| s |                                                                     |
| t |                                                                     |
| a |                                                                     |
| b |                                                                     |
| l |                                                                     |
| i |                                                                     |
| s |                                                                     |
| h |                                                                     |
| m |                                                                     |
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| n |                                                                     |
| t |                                                                     |
| o |                                                                     |
| f |                                                                     |
| t |                                                                     |
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| e |                                                                     |
| s |                                                                     |
| p |                                                                     |
| o |                                                                     |
| n |                                                                     |
| s |                                                                     |
| o |                                                                     |
| r |                                                                     |
| i |                                                                     |
| n |                                                                     |
| t |                                                                     |
| h |                                                                     |
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| u |                                                                     |
| r |                                                                     |
| o |                                                                     |
| p |                                                                     |
| e |                                                                     |
| a |                                                                     |
| n |                                                                     |
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| c |                                                                     |
| o |                                                                     |
| n |                                                                     |
| o |                                                                     |
| m |                                                                     |
| i |                                                                     |
| c |                                                                     |
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| r |                                                                     |
| e |                                                                     |
| a |                                                                     |
| . |                                                                     |
| * |                                                                     |
| * |                                                                     |
+---+---------------------------------------------------------------------+

+---+----------------------+------------+--------------------------------+
| * |                      |            |                                |
| * |                      |            |                                |
| 4 |                      |            |                                |
| ) |                      |            |                                |
| I |                      |            |                                |
| n |                      |            |                                |
| f |                      |            |                                |
| o |                      |            |                                |
| r |                      |            |                                |
| m |                      |            |                                |
| a |                      |            |                                |
| t |                      |            |                                |
| i |                      |            |                                |
| o |                      |            |                                |
| n |                      |            |                                |
| o |                      |            |                                |
| n |                      |            |                                |
| t |                      |            |                                |
| h |                      |            |                                |
| e |                      |            |                                |
| s |                      |            |                                |
| p |                      |            |                                |
| o |                      |            |                                |
| n |                      |            |                                |
| s |                      |            |                                |
| o |                      |            |                                |
| r |                      |            |                                |
| w |                      |            |                                |
| h |                      |            |                                |
| o |                      |            |                                |
| s |                      |            |                                |
| e |                      |            |                                |
| m |                      |            |                                |
| a |                      |            |                                |
| i |                      |            |                                |
| n |                      |            |                                |
| b |                      |            |                                |
| u |                      |            |                                |
| s |                      |            |                                |
| i |                      |            |                                |
| n |                      |            |                                |
| e |                      |            |                                |
| s |                      |            |                                |
| s |                      |            |                                |
| i |                      |            |                                |
| s |                      |            |                                |
| o |                      |            |                                |
| u |                      |            |                                |
| t |                      |            |                                |
| s |                      |            |                                |
| i |                      |            |                                |
| d |                      |            |                                |
| e |                      |            |                                |
| t |                      |            |                                |
| h |                      |            |                                |
| e |                      |            |                                |
| E |                      |            |                                |
| u |                      |            |                                |
| r |                      |            |                                |
| o |                      |            |                                |
| p |                      |            |                                |
| e |                      |            |                                |
| a |                      |            |                                |
| n |                      |            |                                |
| C |                      |            |                                |
| o |                      |            |                                |
| m |                      |            |                                |
| m |                      |            |                                |
| u |                      |            |                                |
| n |                      |            |                                |
| i |                      |            |                                |
| t |                      |            |                                |
| y |                      |            |                                |
| * |                      |            |                                |
| * |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   | NAME / CORPORATE     |            |                                |
|   | NAME                 |            |                                |
|   |                      |            |                                |
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   | CONTACT              |            |                                |
|   | PERSON / TITLE       |            |                                |
|   |                      |            |                                |
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   | ADDRESS              |            | TELEPHONE                      |
|   |                      |            |                                |
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   |                      |            | TELEFAX                        |
|   |                      |            |                                |
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   |                      |            | E-MAIL                         |
|   |                      |            |                                |
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   | COUNTRY              |            |                                |
|   |                      |            |                                |
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
| * |                      |            |                                |
| * |                      |            |                                |
| 5 |                      |            |                                |
| ) |                      |            |                                |
| O |                      |            |                                |
| t |                      |            |                                |
| h |                      |            |                                |
| e |                      |            |                                |
| r |                      |            |                                |
| I |                      |            |                                |
| n |                      |            |                                |
| f |                      |            |                                |
| o |                      |            |                                |
| r |                      |            |                                |
| m |                      |            |                                |
| a |                      |            |                                |
| t |                      |            |                                |
| i |                      |            |                                |
| o |                      |            |                                |
| n |                      |            |                                |
| * |                      |            |                                |
| * |                      |            |                                |
|   |                      |            |                                |
| a |                      |            |                                |
| \ |                      |            |                                |
| ) |                      |            |                                |
| S |                      |            |                                |
| c |                      |            |                                |
| i |                      |            |                                |
| e |                      |            |                                |
| n |                      |            |                                |
| t |                      |            |                                |
| i |                      |            |                                |
| f |                      |            |                                |
| i |                      |            |                                |
| c |                      |            |                                |
| a |                      |            |                                |
| d |                      |            |                                |
| v |                      |            |                                |
| i |                      |            |                                |
| c |                      |            |                                |
| e |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   | Has scientific       |            |                                |
|   | advice been given by |            |                                |
|   | the CHMP for this    |            |                                |
|   | medicinal product?   |            |                                |
|   |                      |            |                                |
|   | Yes No               |            |                                |
+---+----------------------+------------+--------------------------------+
|   | If yes, please       | Reference  |                                |
|   | provide Date of the  | of the     |                                |
|   | scientific advice    | scientific |                                |
|   | meeting              | advice     |                                |
|   | *(mm/dd/yyyy)*       | letter     |                                |
|   |                      |            |                                |
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   | **Note**: Please     |            |                                |
|   | append a copy of the |            |                                |
|   | scientific advice    |            |                                |
|   | letter.              |            |                                |
+---+----------------------+------------+--------------------------------+
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   | b\) Protocol         |            |                                |
|   | assistance           |            |                                |
+---+----------------------+------------+--------------------------------+
|   | Do you intend to     |            |                                |
|   | seek protocol        |            |                                |
|   | assistance for this  |            |                                |
|   | medicinal product?   |            |                                |
|   |                      |            |                                |
|   | Yes No               |            |                                |
+---+----------------------+------------+--------------------------------+
|   | If yes, please       |            |                                |
|   | provide the          |            |                                |
|   | projected date       |            |                                |
|   |                      |            |                                |
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   | c\) Application for  |            |                                |
|   | marketing            |            |                                |
|   | authorisation        |            |                                |
+---+----------------------+------------+--------------------------------+
|   | Please provide       |            |                                |
|   | details on the       |            |                                |
|   | planned submission   |            |                                |
|   | of the marketing     |            |                                |
|   | authorisation        |            |                                |
|   | application for the  |            |                                |
|   | orphan indication,   |            |                                |
|   | if known.            |            |                                |
|   |                      |            |                                |
|   |                      |            |                                |
+---+----------------------+------------+--------------------------------+
|   | Do you intend to     |            |                                |
|   | seek protocol        |            |                                |
|   | assistance for this  |            |                                |
|   | medicinal product?   |            |                                |
|   |                      |            |                                |
|   | Yes No               |            |                                |
+---+----------------------+------------+--------------------------------+

+---+-----------------------------------+--------------------------------+
| * |                                   |                                |
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+---+-----------------------------------+--------------------------------+
|   | NAME / CORPORATE NAME             |                                |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | CONTACT PERSON / TITLE            |                                |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | ADDRESS                           | TELEPHONE                      |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   |                                   | TELEFAX                        |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   |                                   | E-MAIL                         |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   | COUNTRY                           |                                |
|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
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+---+-----------------------------------+--------------------------------+
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|   |                                   |                                |
|   |                                   |                                |
+---+-----------------------------------+--------------------------------+
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+---+-----------------------------------+--------------------------------+
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+---+-----------------------------------+--------------------------------+

+---+--------------------------------------+---------------------------+---+
| * |                                      |                           |   |
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+---+--------------------------------------+---------------------------+---+
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+---+--------------------------------------+---------------------------+---+
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+---+--------------------------------------+---------------------------+---+
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+---+--------------------------------------+---------------------------+---+
| S |                                      | Place                     |   |
| P |                                      |                           |   |
| O |                                      |                           |   |
| N |                                      |                           |   |
| S |                                      |                           |   |
| O |                                      |                           |   |
| R |                                      |                           |   |
| - |                                      |                           |   |
| - |                                      |                           |   |
| S |                                      |                           |   |
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| e |                                      |                           |   |
+---+--------------------------------------+---------------------------+---+
| T |                                      | Date *(mm/dd/yyyy)*       |   |
| i |                                      |                           |   |
| t |                                      | *     *                   |   |
| l |                                      |                           |   |
| e |                                      |                           |   |
|   |                                      |                           |   |
|   |                                      |                           |   |
|   |                                      |                           |   |
|   |                                      |                           |   |
|   |                                      |                           |   |
|   |                                      |                           |   |
+---+--------------------------------------+---------------------------+---+
|   |                                      |                           |   |
+---+--------------------------------------+---------------------------+---+
|   |                                      |                           |   |
+---+--------------------------------------+---------------------------+---+
|   | Public reporting burden for this     |                           |   |
|   | collection of information is         |                           |   |
|   | estimated to average 32 hours per    |                           |   |
|   | response, including time for         |                           |   |
|   | reviewing instructions, searching    |                           |   |
|   | existing data sources, gathering and |                           |   |
|   | maintaining the data needed, and     |                           |   |
|   | completing and reviewing the         |                           |   |
|   | collection of information. Send      |                           |   |
|   | comments regarding this burden       |                           |   |
|   | estimate or another aspect of this   |                           |   |
|   | collection of information, including |                           |   |
|   | suggestions for reducing this burden |                           |   |
|   | to:                                  |                           |   |
|   |                                      |                           |   |
|   | > Department of Health and Human     |                           |   |
|   | > Services                           |                           |   |
|   | >                                    |                           |   |
|   | > Food and Drug Administration       |                           |   |
|   | >                                    |                           |   |
|   | > Office of Orphan Products          |                           |   |
|   | > Development                        |                           |   |
|   | >                                    |                           |   |
|   | > 5600 Fishers Lane                  |                           |   |
|   | >                                    |                           |   |
|   | > Rockville, MD 20875                |                           |   |
|   |                                      |                           |   |
|   | *An agency may not conduct or        |                           |   |
|   | sponsor, and a person is not         |                           |   |
|   | required to respond to, a collection |                           |   |
|   | of information ­unless it displays a  |                           |   |
|   | currently valid Office of Management |                           |   |
|   | and Budget (OMB) control number.*    |                           |   |
+---+--------------------------------------+---------------------------+---+
|   |                                      |                           |   |
+---+--------------------------------------+---------------------------+---+