Blue-box requirements mean additional information on labelling/package leaflet of medicinal products that may be required nationally in accordance with Articles 57 and 62 of Directive 2001/83/EC. The country-specific blue-box requirements are described on the CMDh website.
In Finland, additional information that must be added in the package leaflet includes instructions in case of overdosing, and two other texts mentioned in the instructions (“to treat other illnesses” and “driving ability) can be included, if seen relevant by the applicant. In addition, the translations of the blue-box texts required by the Swedish Medical Products Agency must be included in any Nordic package leaflets.
QRD Template Appendix V
Texts urging users to report any side effects must be added to the summary of product characteristics and the package leaflet in accordance with the attached file.
QRD template appendices on the EMA website
All excipients of the medicinal product must be listed under SPC Section 6.1 and PL Section 6. Certain excipients that may be considered to be of significance for the user must also be stated in the package labelling, under SPC Section 2 and PL Section 2. Such excipients with the relevant warning statements have been listed in the guideline available on the EMA website:
The storage conditions of medicinal products must be indicated in accordance with the EMA Guideline on declaration of storage conditions (PDF).
The approved wording for indicating the storage conditions in the summary of product characteristics, package leaflet and labelling can be found in QRD Template Appendix III with their translations.
Pharmacovigilance related updates
The marketing authorization holder (MAH) for a medical product is responsible for updating the product information in relation to new knowledge or recommendations regarding safety. The links below are useful in keeping track on latest updates.
Post-Authorisation Safety Studies (PASS)
Referral procedures often lead to updates of product information. Information on all referrals with template texts can be found on the search at EMA website:
CMDh has published recommeded and core texts for certain products/product groups.
Changes to texts on medicinal products for paediatric use
Assessments of the results of clinical studies performed on children in accordance with Articles 45 and 46 of the Regulation of Paediatric Medicines may lead to updates of product information of various levels. The assessments in accordance with Article 45, and Article 46 related to national marketing authorisations, are performed within the scope of CMDh) operations. The Public Assessment Reports made of such studies, including the approved texts, are available on the CMDh website. In the centralised procedure, assessments in accordance with Article 46 can be found in the European Public Assessment Report (EPAR) for the particular product.
- Assessment Reports in accordance with Article 45 on the CMDh website
- Assessment Reports in accordance with Article 46 on the CMDh website
Read more (Articles 45 and 46)
EMA Paediatric Medicines: Submitting results of paediatric studies