Spc qrd template

Safety information DHPC. Blood safety Authorisation and inspection of blood establishments. Tissue safety Certification, authorisation, and inspection of tissue establishments. Austrian Pharmacopoeia Draft monographs for comments Archive of monographs Archive of deleted monographs. SmPC and PL 1. For which proprietary medicinal products do the readability, clarity, and user-friendliness have to be assessed in a readability test?

When do the results of the readability test have to be submitted? Are there exceptions to the requirement to submit a readability test?

Are the QRD templates also binding for Package Leaflets that have already undergone a readability test? Does a readability test have to be performed when a Package Leaflet is adapted to the new QRD template? Does the Package Leaflet PL of a new application for marketing authorisation for a generic medicinal product have to undergo readability testing even if the PL directly corresponds to the PL of the reference medicinal product? Does a readability test also have to be submitted for already authorised proprietary medicinal products?

In what form and where in the dossier should the readability test results be presented? Under which conditions can a bridging report rather than a readability test report be submitted? How should medical terms be translated in the Package Leaflet? Recommended translations 6. Does a certain type of readability test have to be performed? Are there any stylistic recommendations? When do the Blue Box requirements for Austria apply? When were the updated versions of the QRD templates published?

Which timelines apply for adapting the product information to the new template? Do we have to use all headings and standard sentences from the QRD template? Placement of a Speech Code in Summary of product characteristics, Package leaflet or Labelling — what do I have to consider and what is the procedure?

Additional linguistic corrections in the Swedish and Finnish language templates have been implemented. Please do not include any personal data , such as your name or contact details. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.

National translations of the combined label and leaflet template can be found on the EMA website. QRD template v8. Implementation plan. It will take only 2 minutes to fill in. Cookies on GOV. UK We use some essential cookies to make this website work. Accept additional cookies Reject additional cookies View cookies.

Hide this message. Home Environment Wildlife, animals, biodiversity and ecosystems. Guidance Summary of Product Characteristics and product literature for veterinary medicines. Print this page. You must also provide: copies of the SPC and labelling of the product you intend to import samples of both the immediate and secondary packaging as intended for sale on the UK market MAPIs are subject to the normal labelling requirements as set out in the Product Literature Standard.

In addition, the following statements should appear on the outer packaging: Manufactured by [name of the MAH of the parent product] Procured from within the EU and repackaged by the licence holder [name and address of MAPI holder] Adverse events should be reported to the licence holder. Revised Mock-Ups Upon completion of the assessment phase we may ask you to submit revised mock-ups reflecting the agreed QRD text where applicable which will be assessed during a separate mock-up phase.

We will usually request mock-ups for: all new MA and VHR applications all variation-extension applications renewals and variations where the number of changes or Type of change being proposed means it would be easier to see revised mock-ups rather than annotating the changes ourselves.

The 2 strikes system If you are asked to submit revised mock-ups for assessment, you must do so in accordance with the PLS and agreed QRD text. Authorisation documentation Following approval of an application, we will send you copies of the final agreed versions of the SPC , QRD Text and mock-ups, as applicable.