Important news on pharmacovigilance and labelling of medicines

We draw your attention to the changes in the regulation of medicines regarding:

• publication of the Risk Management Plan (RMP) summary on the State Expert Center website for public access,
• technical features regarding indication of prefixes (serial number, expiration date) in the packaging graphic layouts and logos in the labeling texts.

Both procedures are caused not by changes in the current legislation, but by changes in operation practices.

1. Publication of the RMP summary for public access.
In accordance with section V of the Procedure for the Implementation of Pharmacovigilance (Order of the Ministry of Health 898), the requirements for the publication of the RMP summary have been in effect since 2016.
In March 2023, the State Expert Center of the Ministry of Health of Ukraine posted the notice on publishing the non-confidential RMP summary for public access.
This procedure is separate from the RMP submission during registration, re-registration or changes.

For RMPs that were not previously assessed and approved in Ukraine
After the RMP is assessed and approved within the framework of the registration, re-registration or variations procedure, it is required to submit the RMP summary in PDF format together with the cover letter to the State Expert Center e-mail address within 30 calendar days.

For RMPs that were previously assessed and approved in Ukraine
If the RMP was submitted, assessed and approved earlier, then it is required to submit the summary of the last agreed version of the RMP with the cover letter to the State Expert Center e-mail address.
The deadline for this procedure is not specified.

The RMP summary should be submitted:

• for all applications for registration, except in cases when the RMP submission is not provided;
• for RMP updates within the post-marketing period.

The RMP summary is compiled in Ukrainian, in accordance with the requirements specified on the State Expert Center website.
The RMP summary translation should be of high quality, with stylistically and grammatically correct special medical terminology.

We remind you that the RMP update for registered medicinal products is carried out as changes to the registration materials (B.1.11).
At the same time, the RMP summary must be updated to reflect any important changes in the RMP and correspond to other parts of the RMP/modules.

We recommend taking this requirement into account both for medicines submitted for registration and for registered medicines.

2. Variable data prefixes and logos in labeling and packaging layouts
Regarding prefixes
The approach regarding some nuances of visual control of packaging during the state quality control is changing.
Previously, it was allowed not to indicate the verbatim wording of prefixes for variable data (serial numbers, expiration dates, etc.) in the labeling text, it was sufficient to declare their presence on the packaging.
The final wording of these prefixes was determined by the manufacturer at the stage of developing packaging layouts, and the layouts in their final form were submitted for registration in the Unified Automated Information System of the control bodies.

For example, the indication of the expiration date was stated in the labeling, and later it could be displayed as “EXP:”, “ED”, “Expiration date:”, etc. in the layout; registered in this form in the State Service of Ukraine on Medicines and Drugs Control, and printed on the packaging in full accordance with the registered layout.

For a long time, this approach did not cause any comments during quality control when importing products to the territory of Ukraine.

Recently, control authorities may classify this method of describing variable data as non-compliance of packaging layouts with the approved labeling text, which, accordingly, may lead to comments during quality control when importing products.

Regarding logos
It is recommended to clarify the data regarding the logos in the labeling: the MAH’s logo, the manufacturer’s logo, etc. during registration, re-registration and amendment procedures.

We recommend you to make changes to the labeling text and specify the exact wording, if necessary, submit updated graphic files to the Unified Automated Information System of the State Service of Ukraine on Medicines and Drugs Control.

If you need support with pharmacovigilance or with labeling of medicines, please contact us by e-mail info@cratia.ua or by tel +38 044 332-42-94.