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Version 10.4, 02/2024ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS [NOTE: the following are those items of information required by Article 11 of Directive 2001/83/EC and current practice in the centralized

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How to fill out qrd product-information annotated template

01

Start by downloading the QRD product-information annotated template.

02

Fill out the general product information section, including product name, description, and intended use.

03

Complete the product specifications section, including product dimensions, materials used, and any relevant certifications.

04

Provide information on packaging, labeling, and shelf life of the product.

05

Include any warnings or contraindications related to the use of the product.

06

Submit the completed template for review and approval.

Who needs qrd product-information annotated template?

01

Pharmaceutical companies

02

Medical device manufacturers

03

Healthcare product distributors

04

Regulatory authorities

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What is qrd product-information annotated template?

The QRD product-information annotated template is a standardized document used to provide comprehensive product information for medicinal products in a clear and consistent manner, facilitating approvals and information dissemination.

Who is required to file qrd product-information annotated template?

Pharmaceutical companies and marketing authorization holders are required to file the QRD product-information annotated template for their medicinal products.

How to fill out qrd product-information annotated template?

To fill out the QRD product-information annotated template, applicants must follow the specific guidelines provided in the template, ensuring that all required fields are completed accurately and in accordance with the relevant regulations.

What is the purpose of qrd product-information annotated template?

The purpose of the QRD product-information annotated template is to ensure uniformity and clarity in product information, aiding regulatory authorities, healthcare professionals, and patients in understanding the product's characteristics and use.

What information must be reported on qrd product-information annotated template?

The QRD product-information annotated template must report information such as product name, active substances, dosage form, indications, contraindications, side effects, and storage conditions, among other relevant details.

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