Product Information in the EU

In order to obtain a marketing authorization, a Summary of Product Characteristics (SmPC) in accordance with Article 11 of Directive 2001/83/EC must be included in the application. In accordance with Directive 2001/83/EC, when the marketing authorization is issued, the Marketing Authorization Holder shall be informed, by the competent authorities of the Member States concerned, of the SmPC as approved by it. For decisions concerning centralized marketing authorizations, according to Article 10 of Regulation (EC) No 726/2004, the final Commission decision with the SmPC is addressed and notified to the Marketing Authorization Holder.

It is not in the remit of the SmPC to give general advice on the treatment of particular medical conditions. On the other hand specific aspects of the treatment related to use of the medicinal product or its effects should be mentioned. Similarly, general advice on administration procedures should not be included but any advice specific to the concerned medicinal product should be included. Advice on the principles of presenting information in the SmPC is important to create clear documents. Applicants should maintain the integrity of each section of the document by only including information in each section which is relevant to the section heading. However, some issues may need to be addressed in more than one section of the SmPC and in such situations the individual statements may cross-refer to other sections when these contain relevant additional information. Separate SmPCs are required for each pharmaceutical form and strength by the European Commission and certain Member States. Limited references to other strengths or pharmaceutical forms of the same medicinal product may be necessary in a SmPC if the dosage regimen is based on the use of several strengths or pharmaceutical forms. For the purposes of giving information to prescribers, the SmPCsof different pharmaceutical forms and strengths may be combined for appropriate products within the same range.

The SmPC should be worded in clear and concise language and each section of the SmPC should first deal with those issues that apply to the core population for whom the medicine is indicated followed - when necessary – by specific information for any relevant special population (e.g. children or elderly). Consistent medical terminology should be used throughout the SmPC. For example, the use of MedDRA as described in the annex for section 4.8 should be applied though the SmPC, in particular for sections 4.3 and 4.4 and 4.8. The SmPC provides information on a particular medicinal product; therefore it should not include reference to other medicinal products (e.g. through statement such as “Like other medicines of the same class …”) except when it is a class warning recommended by a competent authority.

The package leaflet is intended for the patient/user. If the package leaflet is well designed and clearly worded, this maximizes the number of people who can use the information, including older children and adolescents, those with poor literacy skills and those with some degree of sight loss. Companies are encouraged to seek advice from specialists in information design when devising their house style for the package leaflet to ensure that the design facilitates navigation and access to information. Some people may have poor reading skills, and some may have poor health literacy. Aim to use simple words of few syllables. Long sentences should not be used. It is better to use a couple of sentences rather than one longer sentence, especially for new information. Long paragraphs can confuse readers, particularly where lists of side effects are included. The use of bullet points for such lists is considered more appropriate. Where possible, no more than five or six bullet points in a list are recommended.

When setting out the side effects it is particularly important to consider the order in which they are given so the patients/users may maximize the use of the information. In general, setting out the side effects by frequency of occurrence, starting with the highest frequency, is recommended to help communicate the level of risk to individuals. Frequency terms should be explained in a way patients/users can understand – for example “very common” (more than 1 in 10 patients). However, where a serious side effect exists which would require the patient/user to take urgent action this should be afforded greater prominence and appear at the start of the section. Setting side effects by organ/system/class is not recommended since patients/users are in general not familiar with these classifications.

Why should you Attend: Product Information consist of the Summary of Product Characteristics (SmPC), labelling text and package leaflet. The SmPC forms an intrinsic and integral part of the marketing authorization. It sets out the agreed position of the medicinal product as distilled during the course of the assessment process. As such the content cannot be changed except with the approval of the originating competent authority.

SmPCs are a key part of the marketing authorization of all medicines authorized in the European Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively. They are kept updated throughout the lifecycle of a medicine as new efficacy or safety data emerge. The SmPC should be worded in clear and concise language. SmPCs are also the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients. This webinar provides advice on the principles of presenting information in the SmPC.

The text on the label and the package leaflet are usually the only items the patient will see from all documents included in a marketing authorization application, so it is very important that the texts are clear and of a high quality. Knowledge of how to write a package leaflet and which guidance documents are important is also vital to pass the so-called “user testing” which is mandatory before a medicinal product can be approved in the EU. Deviation from the guidelines should be justified in the Marketing Authorization Applications. This webinar provides an overview of the relevant guidance documents and practical advice of how to write the Product Information.

Areas Covered in the Session:

• Important EU product information guidance documents for the SmPC
• Discussion of each section of the SmPC
• Guidelines on the packaging information and excipients
• Consultation with Target Patient Groups

• Senior management
• Project Managers
• Medical writers
• CRAs and CRCs
• QA / Compliance personnel
• Investigators
• Clinical Research Scientists
• QA / QC Auditors and Staff
• Consultants