
Mock-ups and labeling as part of the registration dossier for a medicinal product
Section 1.3.2 of Module 1 of the registration dossier for a medicinal product requires the provision of mock-ups and labeling text, which are drawn up in accordance with Decision 76.
As a rule, in the most typical cases, when registering a drug/harmonization of the dossier with the requirements of the EAEU, the following is submitted:
- Mock-ups of secondary (consumer) packaging - packaging in which medicine is placed in primary or intermediate packaging for sale to the consumer;
- Mock-ups of primary packaging - packaging in direct contact with the drug;
- The text of the labeling which is a separate document that contains information printed on the packaging (primary and secondary in the typical case) of the medicinal product.
In some cases, mock-ups of intermediate packaging are also provided.
According to Decision 76, the following information is indicated on the primary packaging:
- Trade name of the drug;
- International nonproprietary name (INN) (if available) or common (group) name - may not be indicated if the primary packaging is small;
Dosage form – may not be indicated if there is secondary packaging;
- Dosage and (or) activity and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances);
- The number of medicines in the package – may not be indicated if there is secondary packaging;
- Route of administration – may not be indicated if included in the name of the dosage form;
- The name or logo of the marketing authorization holder (MAH) or manufacturer (if necessary) of the drug - may not be indicated if the primary packaging is small;
- Serial number;
- Expiration date ("best before...").
Secondary packaging must contain the following information:
- Trade name of the drug;
- INN (if available) or common (group) name;
- Names of MAH and drug manufacturer;
- Address of MAH and drug manufacturer;
- Dosage form;
- Dosage, and (or) activity, and (or) concentration (if applicable) of the active pharmaceutical substance (active pharmaceutical substances);
- Number of medicines in the package;
- Information on the composition of the drug;
- Serial number;
- Manufacturing date;
- Expiration date (“best before...”);
- Storage conditions and, if necessary, transportation conditions;
- Route of administration - may not be indicated if included in the name of the dosage form;
- Dispensing requirements;
- Warning notices;
MAH has the right to indicate the full composition of the drug, but is not obliged to do so. However, there is a list of excipients, the indication of which is mandatory (Annex 1 to Decision 76) on the secondary packaging of medicinal products for oral administration. These include, for example, lactose and various azo dyes.