Changes in assessment and publication of information on the mock-ups of medicinal products

Information for marketing authorisation holders

The State Agency of Medicines informs that starting from 14 November 2016 the mock-ups of the inner and outer packaging might be submitted by marketing authorisation holders only for information without any further assessment and publication on the website of the State Agency of Medicines www.zva.gov.lv.

Consequently, only Word format labelling text that has been approved as part of authorisation, renewal and variation procedures will be published in the section Register of the website of the State Agency of Medicines.

Please note that the marketing authorisation holder is still responsible for the preparation of accurate mock-up for medicinal product packaging by ensuring its compliance with the labelling text approved by the State Agency of Medicines and complying with the requirements of appropriate normative acts of the Republic of Latvia and European Community guidelines. Please pay attention to the following when preparing a mock-up of the medicinal product packaging:

• The information must be easily legible and comprehensible;
• The use of symbols and pictograms that clarify the information and are useful to the patient is allowed without permitting any elements of advertising and without compromising the legibility of information that is important to the patients;
• If a multilingual packaging is being prepared, the data provided must be identical in all languages;
• The medicinal product storage conditions indicated on the mock-up must be the same as indicated in the rest of the product information;
• Any machine readable code (for example, 2D, QR codes) may contain only coded information that is necessary to ensure manufacturing quality;
• Only abbreviations which have been agreed upon during authorisation, renewal or variation procedures may be used.

Prior to the preparation of multilingual labelling for medicinal product packaging we recommend verifying that all of the necessary information in all of the languages can be fitted on the mock-up.

Please be informed that in some cases the State Agency of Medicines may ask marketing authorisation holders to submit mock-ups of inner and/or outer packaging to verify that the information indicated on the mock-ups complies with the requirements of normative acts.