Regarding approval of labelling

Information in the labelling text shall be renewed for medicinal products, which in accordance with the requirements of Article 54a of the Directive 2001/83/EC, shall bear the safety features.

With regards to approval of the Regulation 2016/161, in February 2016 the European Medicines Agency (EMA) renewed the product information standard forms accordingly (QRD template), where in the labelling text (Word document) Paragraphs 17 (Unique identifier – 2D bar code) and 18 (Unique identifier – data, which can be read by a person) were introduced in addition. That means that until the requirements on safety features coming into force (February 2019), the information in the labelling text shall be renewed (i.e., in the Word document), including Paragraphs 17 and 18 there accordingly. In order to make the approval of the revised labelling texts more simple/ more convenient/ related to less costs  for medicinal products, which are registered according to the national registration procedure, it is possible to do it with any changes in the registration documentation related to information of the product without additional charge. Companies shall not submit to the State Agency of Medicines (ZVA) for approval the packaging of medicines (or so called draft labelling, mock-up), where the unique identifiers are indicated.

Dace Peiseniece
Deputy Head of the Department for Registration of Medicines – Head of the Pharmaceutical Information Evaluation Division, the State Agency of Medicines