Product Information and mock-ups verification
The Product Information (PI) includes the summary of product characteristics (SmPC), the package leaflet and the labelling. It is an officially approved, public set of drug-specific information, available for both healthcare professionals and patients, expressed in descriptive form and tailored to each of these groups. They can be considered as a summary of the information contained in the full dossier of the medicinal product.
Every marketed product is also required to have mock-ups (also known as artworks), approved by the relevant Registration Authority, which are a visual representation of the labelling and leaflet in the target colour scheme, layout and dimensions. These are the mock-ups from which the packaging and leaflets are made, which go straight into the hands of the patient.
It is essential that these documents meet the legal criteria, are of the high quality and legible for the medicine user – to this end, a thorough and multifaceted verification is required. before submission to the Registration Authorities, including compliance with the current guidelines and the Quality Review of Documents (QRD) templates developed by the EMA, which are the basis for preparing information about a product.
Why and when should the PI and mock-ups be verified?
The Marketing Authorisation Holder is required to submit the Product Information, in some cases also mock-ups for evaluation to the relevant Competent Authorities among others, in the following procedures:
- registration of the medicinal product under the national procedures, European procedures: Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP) or Centralised Procedure (CP);
- renewal of marketing authorisations;
- European notifications or national notifications;
- post-registration variations affecting Product Information;
- application for parallel import of a medicinal product.
Each submission of the documentation should be preceded by a detailed review. The verification of Product Information and mock-ups entails an examination of the documents from the following perspectives: content and language, as well as visual presentation in the case of mock-ups, in the context of their readability. Additionally, the compatibility of mock-ups’ body with the corresponding Product Information is evaluated. The accuracy and presentation of information on packaging and leaflets are of utmost importance for patient safety. The proper preparation of these materials is essential for limiting the incorrect use or administration of medicinal products.
Why SciencePharma?
SciencePharma is a leading consulting company that has been providing support to Polish and foreign clients in projects on a national and international level since 2004.
To ensure the high quality of Product Information and mock-ups, and optimise the regulatory process, SciencePharma’s Experts conduct a profound review of documents prior to their submission, from font size or line spacing, to linguistic and content accuracy, to the overall readability of the documents reviewed.
On the basis of knowledge and lifetime experience, we thoroughly check the Product Information and mock-ups provided. In line with current national and European guidelines, our Experts assure that the documents are adapted to the relevant requirements and, if necessary, improved in terms of readability.
Cooperation benefits
Our team of Experts provides the comprehensive services in the field of preparation and submission of dossier for medicinal products. We support Polish and foreign companies in the pre-registration phase, during the registration process and in the post-registration procedures (please click here for further details).
By maintaining close contact with the Marketing Authorisation Holders and Registration Authorities, we ensure a seamless transfer of documents and the processing of the registration activities.
Need expert review? Contact SciencePharma today!
Any submission of Product Information to Registration Authorities should be preceded by a detailed review, taking into account compliance with the guidelines, verification of the content, language and, in the case of mock-ups – visual presentation in the context of readability. The compatibility of the content of the mock-ups with the corresponding product information should also be assessed.
SciencePharma offers the assistance of experts with extensive experience in verifying Product Information and mock-ups. If you need help in this area, please contact us directly using the form below.