The European Parliament’s recommendations for the labelling of medicinal products
The labelling of investigational medicinal products is governed by the “Regulation of the European Parliament on clinical trials on medicinal products for human use”. With correctly translated labelling you will avoid financial penalties and other sanctions resulting from displaying inappropriate or incorrect information. Using the services of professional specialist translators is a guarantee of guideline-compliant translations.
Investigational medicinal product labelling – objective and key principle
The labelling procedure has two main goals:
• to guarantee the safety of study subjects thanks to access to product information;
• to enhance the reliability of the data collected during the study.
According to the Regulation, all details must be displayed clearly – so that the rele-vant information can be easily found on the packaging. This is the most important principle of the entire process. Some information can be presented in the form of symbols or pictograms (e.g. warnings). You might want to try our DTP services to make sure the particulars displayed on the packaging are clear and that the graphic elements are correct.
What information needs to be provided?
The European Commission lists 10 details to be displayed on the outer and immedi-ate packaging. The following particulars must be displayed on the packaging of medicinal products which have not been placed on the market:
1. Phone number and full name of the contact person or the name and address of the company
2. Substance name and strength. For blind trials, the name of the placebo/comparator is also required.
3. Pharmaceutical form, administration route and recommended daily dose
4. Batch number/code
5. Trial reference code
6. Study subject/treatment identification number
7. Directions for use – reference to the attached leaflet with detailed instructions is sufficient.
8. Direct notice that the product must be only be used for the clinical trial. If study subjects take the product home, the packaging must include the notice: “Keep out of reach of children”.
9. Storage conditions
10. Expiry date/re-test date
Much less information is required for medicinal products which have already been placed on the market. It includes the contact details of the designated person/company, the trial reference code and the information that the product is only to be used for the clinical trial.
Where should the information be placed?
The required particulars should be placed both on the outer and on the immediate packaging. This applies to both authorised and unauthorised products (see: Articles 66 and 67 of the Regulation).
In certain cases, there is no need to include the same information on both types of packaging. These exceptions include:
• if the outer and immediate packaging is provided together, unless not all the required information is stated on the outer packaging;
• small immediate packaging, e.g. ampules (then the outer packaging must be provided and all the required particulars must be displayed there);
In both cases, you may omit the following particulars on the immediate packaging: directions for use, storage conditions, “Keep out of reach of children” and information that the product may only be used as part of the clinical trial.
KONTEKST – Supporting you with the translation of investiga-tional medical product labelling
Would you like to be completely sure that your investigational medicinal product labelling is translated correctly? Try KONTEKST. Our translators are specialists in their fields and are carefully selected to match the type of the translation required. This speeds up the translation process and boosts accuracy so that you can avoid additional corrections. You save time and can be sure that the translated content is correct. Each text is additionally proofread to make sure you only get publication-ready and reliable translations.
Our DTP service is at your disposal to assist you with preparing clear information layout and designing the required pictograms. To learn more, call: +48 22 548 07 00 or email us at: kontekst@kontekst.pl.
