Clinical Site Candidates s1

[Company Name] [Company Group, Division, Location]

Document Title: Promotional Literature Medical Products

Document Number: [Document Number] Document Filename: [Document Filename]

CONTROLLED COPY/ MASTER COPY STAMP HERE

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Revision Revision DCO/ECO Revision Level Date Number Description of Revision Author DRAFT DD/MM/Y YY-00000 Draft Author Name Y 1.00 DD/MM/Y YY-00000 Initial Release Author Name Y

COMPANY PROPRIETARY AND CONFIDENTIAL [Company Name] Promotional Literature Medical Products [Company Group, Division, Location] [Document Number] Rev x.xx DD/MM/YY

Table Of Contents

1.0 Purpose...... 1

2.0 Scope...... 1

3.0 Definition Of Terms...... 1 3.1 Promotional Literature...... 1 3.2 Product Labeling...... 1

4.0 References...... 2

5.0 Responsibilities and Requirements...... 2 5.1 Sales and Marketing...... 2 5.2 Regulatory Compliance...... 2

6.0 Procedure...... 2 6.1 Promotional Literature Submission to Regulatory Compliance...... 2 6.2 Regulatory Compliance Review of Promotional Literature...... 2 6.3 Records of Promotional Literature...... 2

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1.0 Purpose To establish a procedure for the review, approval, and retention of promotional literature for medical products, to assure compliance with regulatory requirements.

2.0 Scope This procedure applies to promotional literature developed by (Company Name), for all medical products manufactured at all facilities of (Company Name). This procedure does not apply to promotional literature developed by other companies who market products manufactured at the facilities of (Company Name). This procedure does not apply to promotional literature developed by (Company Name), for products not manufactured at the facilities of (Company Name).

3.0 Definition Of Terms

3.1 Promotional Literature Any literature in any media (printed, electronic, video, etc.) used to advertise or publicize the company or its products, excluding product labeling (note: product labeling is released and controlled according to the Product Labeling document). Articles submitted to trade or professional journals by (Company Name), employees regarding (Company Name) or (Company Name) products are considered promotional literature. (Company Name), press releases also are considered promotional literature.

3.2 Product Labeling Written or pictorial information provided on or included with a product, describing the product function, intended use, precautions, content, quantity, etc. It includes physician's manual and user's manual or instructions.

4.0 References Product Labeling

5.0 Responsibilities and Requirements [Identify the roles and responsibilities for the following departments].

5.1 Sales and Marketing

5.2 Regulatory Compliance

6.0 Procedure

6.1 Promotional Literature Submission to Regulatory Compliance [Explanation of who is responsible for submitting promotional literature to Regulatory compliance].

6.2 Regulatory Compliance Review of Promotional Literature Regulatory compliance will review the literature according to FDA standards and examine (Company Name)'s quality systems registrar, the laws and regulations of the countries targeted for distribution of the promotional literature, and other regulatory requirements as appropriate. Regulatory Compliance also will review the promotional literature for any possible misstatement or misrepresentation of material fact, including that of omission.

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If the promotional literature cannot be approved as-is, Regulatory Compliance will notify the developer, noting the text or statements causing regulatory noncompliance. When appropriate, Regulatory Compliance may recommend changes to the literature to eliminate regulatory compliance problems. [Identify who in the organization is responsible for fixing the documents and resubmitting them]. Regulatory Compliance will notify the appropriate party when promotional literature is approved for distribution.

6.3 Records of Promotional Literature Regulatory Compliance will retain a copy of the approved promotional literature. If promotional literature is reprinted for distribution, the person distributing the promotional literature is responsible for proofing the reprint and providing Regulatory Compliance with a copy. If promotional literature is published in a trade or professional journal, the person providing the promotional literature to the journal is responsible for proofing the printed copy in the journal and for providing Regulatory Compliance with a copy.

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