NHP On-line System - Invitation to Pilot Phase II Participants

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Pilot Purpose

The second phase of the NHP Online pilot initiative is intended to confirm the practicality of several innovations geared towards Compendial product licence applications. These improvements include a more highly-structured monograph that is easier to understand and an electronic Product Licence Application (e-PLA) form that will present the contents of a chosen monograph for selection and integration into the e-PLA. These newly-structured monographs will be accessible by the end of May in a new release of the NHP Ingredients Database.

Since the critical elements are being selected from within the parameters of a monograph, acceptance and licensing of the product is expected to be very rapid. This is a key step towards an eventual "self-service" model for product licensing.

This is in addition to the services already available to the pilot participants including:

1. Use of an enhanced electronic product licence application (e-PLA) form for five application types:
   1. Compendial - monograph available (functionality added for this pilot);
      - monograph not available (as per initial pilot);
   2. Non-traditional;
   3. Traditional;
   4. TPD Category IV:
   5. Transitional DIN;
2. Use of an electronic Animal Tissue form (included with the e-PLA);
3. Use of an electronic NHP Ingredients Database Change Request Form (included with the e-PLA for non-medicinal ingredients; separately for medicinal ingredients);
4. The registration and enrolment process for electronic applicants including:
   1. Trading Partner agreement;
   2. Trading Partner Profile e-form;
5. Electronic submission of e-PLA's together with required support documents in electronic format;
6. Electronic submission of e-PLA's with required support documents on paper sent separately;
7. Electronic delivery of acknowledgements, of acknowledgements with processing deficiencies (SAPDN's) and of Information Request Notices (IRN's);
8. Electronic submission of an e-PLA and/or attachments in response to an SAPDN or to an IRN.

The e-PLA will also include various enhancements based on feedback from the initial pilot version.

For this pilot, all forms, guidance, support and reviews will be in English only. Both official languages will be supported when the NHP Online System goes into production

Timeframe

For approximately twenty days leading up to the launch of the pilot, potential participants are contacted by e-mail and invited to register provided they meet the published criteria (see Pilot Participant Profile below). Candidates respond by expressing their interest and their commitment to meeting the profile qualifications as well as the technical and PosteCS™¹ account requirements described below.

Candidate responses are sent to an NHPD e-mail account indicated below. Each qualified participant is sent a Trading Partner enrolment package that includes the Trading Partner agreement, a Trading Partner Profile e-form and various types of guidance. As described in the guidance, the participant then submits (by mail or courier) a signed Trading Partner agreement along with the required credentials and a completed Trading Partner Profile. After NHPD review and an interview by telephone, the successful participant candidate is enrolled as a pilot Trading Partner. Upon enrolment, blank electronic forms and explanatory documents to be used for the pilot are sent to the participant via PosteCS to the specific PosteCS account identified in the Trading Partner Profile.

The pilot itself is expected to operate for twelve weeks and receive approximately 100 e-PLA submissions during that period. These submissions are handled by NHPD as production work. During the pilot, there is a designated NHPD PosteCS account for handling questions and exchanging attachments. No telephone support is provided at this time. It is also planned to hold a periodic teleconference with participants as appropriate to handle common issues and possibly introduce new guidance or features for the pilot.

Towards the end of the twelve-week period, participants are invited to complete a questionnaire to be analyzed for the post-pilot review. The questionnaire may be supplemented by a telephone interview - individually or as a teleconference. Results will be shared with the participants and at future industry meetings.

Target Metrics

The secure e-mail pilot is expected to operate over a twelve-week period (June - September) followed by a post-pilot evaluation. The following metrics are sought for the second phase of the pilot:

1. 100 submissions of licence applications and supporting materials:
   1. 100% product licence applications submitted electronically;
   2. 95% are all-electronic submissions (i.e. all supporting documentation is electronically submitted);
   3. 5% have some supporting documentation sent separately by regular mail or courier in addition to the electronic licence application submission;
2. 70 e-mails to participants regarding acknowledgements, SAPDN's, and IRN's;
3. 25 e-mails from participants in response;
4. An average of one delegated user² per pilot participant;

While all types of e-PLA submissions are welcome, the expectation for this pilot is that more Compendial types will be received and issued than any other type.

Pilot Participant Profile

To achieve the above target metrics, the profile of a model pilot participant would be as follows:

1. Able to submit at least 7 to 10 licence applications (including at least 3 compendial type) over a twelve-week period;
2. Able to provide all submission supporting materials in electronic format as attachments; acceptable electronic formats are PDF, Word, WordPerfect, Excel and .tif (fax ready);
3. Able to designate at least one delegated user using the Trading Partner Profile form;
4. Able to provide a single point of contact for pilot activities;
5. Able to meet technical requirements as outlined below;
6. Willing to participate in a mid-pilot review as well as a post-pilot review of the results (survey questionnaire and follow-up telephone interview).

It is expected that fifteen pilot participants with the above profile would enable the achievement of the target metrics.

The pilot participants must have signed Trading Partner agreements and have active PosteCS accounts (see PosteCS Account Requirements below) before the pilot begins.

Technical Requirements

For participation in the pilot, the successful candidates must use workstations that meet the following technical requirements:

1. MS Internet Explorer v6.0 or higher;
2. XP with Service Pack 2 or Windows 2000 with Service Pack 4 as operating system. Vista is not being considered for the pilot at this time;
3. High-speed internet connection (high-speed dial-up may be bearable);
4.  Adobe Reader v8.1 or higher (available free at www.adobe.com);
5. Ability to handle zip files;
6. Pentium 4 processor at 1.6 GHz or faster;
7. 1 Gb main memory or more;
8. Storage capacity of at least 10 Mb disk space per application submission (equivalent of 200 -2,000 single-sided pages depending on electronic format and graphics content of supporting documentation).

PosteCS Account Requirements

Canada Post offers a free trial period for new PosteCS accounts. Pilot candidates must enroll with  PosteCS to have an active PosteCS address before submitting enrolment documents for the NHP Online pilot. Enrolment is done over the web at:
www.canadapost.ca/business/offerings/postecs/can/default-e.asp

There are two requirements to be met when signing up for PosteCS for this pilot:

1. In the Account Information tab, the Department Code must be HC-NHPD;
2. After confirmation for enrolment, the candidate will have the opportunity to configure account preferences. For New Package Preferences, the Security selection must be Account Password Protection.

More details are available on the Canada Post PosteCS website indicated above.

How to Express Interest in Being a Pilot Participant

Candidates prepared to meet the above qualifications should send an e-mail to the NHPD address below. The content of the e-mail should clearly indicate the following:

1. Expressed commitment to meet all six qualifications of the Pilot Participant Profile;
2. Expressed commitment to meet all eight Technical Requirements;
3. Expressed commitment to obtain a PosteCS account and to meet both PosteCS Account Requirements;
4. Contact name, company name, contact telephone number and e-mail address to receive the Trading Partner enrolment package if accepted as a candidate.

Expressions of interest are sent by e-mail to NHP_initiative_PSN@hc-sc.gc.ca

Expressions of interest that do not clearly indicate ALL of the above information will be given no further consideration.