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  • Quality Review Of Documents Human Product Information Annotated Template English Version 91

Get Quality Review Of Documents Human Product Information Annotated Template English Version 91

Version 9.1, 03/201306/2015 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS NOTE: the following are those items of information required by Article 11 of Directive 2001/83/EC, as amended, and current practice.

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How to use or fill out the Quality Review Of Documents Human Product Information Annotated Template English Version 91 online

Filling out the Quality Review Of Documents Human Product Information Annotated Template English Version 91 is vital for ensuring accurate and comprehensive documentation for medicinal products. This guide provides step-by-step instructions to effectively complete the form online.

Follow the steps to successfully fill out the annotated template:

  1. Click the 'Get Form' button to obtain the template and open it in your online document editor.
  2. Begin by providing the 'Name of the medicinal product' in the designated field. Ensure to follow the format specified in the guidelines.
  3. In the 'Qualitative and Quantitative Composition' section, list all active substances along with their concentrations and forms.
  4. Complete the 'Pharmaceutical Form' section clearly indicating the type of formulation your product is available in (e.g., tablet, solution).
  5. Fill in the 'Clinical Particulars' section, elaborating on therapeutic indications, posology, and administration methods.
  6. Address potential contraindications and special warnings in section 4 to ensure patient safety and compliance.
  7. Continue to complete information related to pharmacological properties, safety data, and shelf life as instructed in the respective sections.
  8. Once all fields are filled, review the information for accuracy and completeness, based on the provided guidelines.
  9. Save changes to the document when complete. You may download the template, print it, or share it via email or appropriate platforms.

Start filling out your document online today to ensure compliance and efficient submission.

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— immediate packaging means the container or other form of packaging immediately in contact with the medicinal product, — outer packaging means the packaging into which is placed the immediate packaging, (!) OJ No C 58, 8.

The European Medicines Agency's (EMA) Working Group on Quality Review of Documents (QRD) develops, reviews and updates templates for product information for use by applicants and marketing authorisation holders for human medicines. The information contained in these documents is non-exhaustive.

Centralised procedures - Quality Review of Documents (QRD) templates. Core SmPC, labelling and package leaflet for ATMPs containing genetically modified cells.

Small immediate packaging units are defined as containers sized up to and including 10 ml. On a case-by-case basis the minimum particulars could also be considered for other containers where it is not be feasible to include all the information.

SmPCs are available online at: MHRA - information is arranged in an A-Z list by active substance, or you can use the free text search box.

The MHRA Best Practice Guidance on Labelling and Packaging of Medicines advises that the pack must include the name of the medicinal product (brand name, followed by its strength and pharmaceutical form) and the generic name(s) of the active ingredients where the product contains up to three active substances.

Line breaks or page breaks should only be used if necessary. FONT: Font: Times New Roman Size: 11 Font style: Regular Character spacing: Normal Font colour: Black (i.e. the text throughout the annexes should be presented in black font, including figures, tables, pictograms, etc.).

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232