Tag Archives: QRD

EMA Publishes Implementation Plan for QRD and Package Leaflets

EMA Publishes Implementation Plan for QRD and Package Leaflets

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The European Medicines Agency and the Quality Review of Documents (QRD) Group have revised the
Human Product Information templates with a special focus on the package leaflet.
This revision is the result of 5 years experience with “user testing” and is based on the feedback
received in various forms and through various sources, i.e. National Competent Authorities,
Pharmaceutical Industry, Academia, Companies involved in user testing, Patient and Consumer groups.
In addition, the revised QRD template has now introduced the concept of benefit (based on the report
on benefit-risk of medicines carried out by the European Medicines Agency), new requirements related
to paediatric information and modifications introduced in relation to conditions to the marketing
authorisation in the Annex II.



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EMA Releases QRD Templates

EMA Releases QRD Templates

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BRACKETING CONVENTION USED IN THE TEMPLATES:
{text} Information to be filled in, i.e. normal text.
<text> Text to be selected or deleted as appropriate.
[Green text] Guidance and explanatory notes only. To be deleted when using the templates.
PAGE SET-UP: Orientation: Portrait
PAGE LAYOUT: Section breaks must be avoided. Line breaks or page breaks should only be used if necessary.
MARGINS: From top of page: 2.0 cm
From bottom of page: 2.0 cm
From left of page: 2.5 cm
From right of page: 2.5 cm
Gutter: 0 cm
Header: 1.3
Footer: 1.3 cm
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.).
LANGUAGE: Use the relevant language settings, i.e. European standard spelling and grammar when editing the text, e.g. English (UK), French (France), Portuguese (Portugal), Spanish (Spain-Modern sort), etc.
TEXT ALIGNMENT: Left alignment, except for title pages where the text is centred.
LINE SPACING: Paragraph: single-line spacing (one line before and one line after must not be used).
Between paragraphs: one additional single-line spacing.
Between headings and text: see information on headings below.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Guidance on On-Pack Design and Labelling

EMA Publish Guidance on On-Pack Design and Labelling

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Pack design and labelling ensure that the critical information necessary for the safe use of a medicine is legible, easily accessible and that users of medicines can easily assimilate this information so that any risk of confusion and error is minimised.
For non-prescription medicines the clear identification and selection of the appropriate medicine is very important, especially in cases where there is no pharmacist intervention, therefore, pack design and labelling are considered key elements to ensure the safe use of this type of medicines.
The information which should be included on the labelling and package leaflet is provided in Title V of Directive 2001/83/EC. In addition, the details on the display and readability of such information on the printed materials are included in the Guideline on the readability of the labelling and package leaflet of medicinal products for human use (Revision 1, 12 January 2009) (hereinafter “Readability guideline”). However, due to the different supply arrangements for non-prescription medicines across Europe, some of the principles of the presentation of the content of the labelling and package leaflet differ among Member States, in particular on the ones regarding the acceptability of symbols/pictograms and any additional information compatible with the Summary of Product Characteristics (SmPC).
A consultation with Member States on national practices regarding pack design and labelling for non-prescription medicines has taken place and this document summarises the basic recommendations/principles1 to guide applicants and marketing authorisation holders when preparing the mock-ups and specimens of the sales presentations2 of non-prescription medicines within the centralised procedure. It is acknowledged that national practices on pack design for non-prescription medicines differ across Member States, therefore, the recommendations included in this document should be considered in this context.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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EMA Publish Draft Revision of QRD Annotated Veterinary Template

EMA Publish Draft Revision of QRD Annotated Veterinary Template.

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The revision of the QRD veterinary product information annotated template was extensively discussed within the European Medicines Agency, the Quality Review of Documents (QRD) group and the Mutual Recognition & Decentralised Procedures – Veterinary (CMDv) group and is now open for external consultation to all interested parties. The purpose of this revision is to update the veterinary template following a CMDv/QRD harmonisation exercise aiming at having one common template for use across the various procedures:

MRP/DCP/referrals and centralised procedures. One common template will be of benefit for regulators at EMA and National Competent Authorities, industry and users (veterinarians, pharmacists, animal/pet owners).
Moreover, the European Medicines Agency has initiated a general revision of the veterinary template to improve/update the SPC, labelling and Package leaflet and, in some cases, to provide more or clearer guidance.

The Annex II (section D) was also amended to reflect the requirements from the new Commission Regulation (EU) N.37/2010 on MRLs.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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