D3. Example labels
An example label for the medicinal product being researched must be submitted for review. The label must meet the requirements set in annex 13 of the Good Manufacturing Practice Guideline (2003/94/EG).
Information on the label
The following information (in Dutch) must be listed on the label, unless there are good reasons not to do so:
- Name, address and telephone number of the sponsor, CRO or investigator (these are contact details which are important when information on the product, the research or deblinding is required in the event of an emergency). Address and telephone number can be omitted if the research subject has been given a patient card or similar which already states this information and the research subject has been given the instruction to always have this card with them.
- Pharmaceutical formulation (tablets, capsules, etc.), the dosage form, the number of dosage units (in open label research: name and dosage of the product).
- The batch and/or code number (for tracing contents and packaging activities).
- A research reference code, allowing identification of research, centre, investigator and sponsor (unless listed elsewhere).
- A research subject/treatment number and if required, a visit number.
- The investigator’s name (if not listed under points 1 or 4).
- Instructions regarding use (can be achieved via referral to included information or the instruction to use the research product as instructed by the doctor).
- Solely destined for clinical research (or similar text).
- Storing conditions.
- Storage life (use-by date, expiration date or re-test date); to be referred to as month/year with clear instructions.
- Keep out of reach of children (unless the research medication is not taken home).
Exceptions
- Research medicinal products in an inner packaging together with an outer packaging, designed to remain attached. The outer packaging lists all the information (points 1 -11) and the inner packaging only lists: 1 (the name only), 2, 3, 4, 5.
- Research medicinal products in an inner packaging too small to list all information (e.g. vials). All information must then be listed on the outer packaging and the inner packaging must only list: 1 (the name only), 2 (the dosage form only (exception: oral fixed dosage forms), name and dosage of the product in open label research), 3, 4, 5.
- Research medicinal products not requiring any unique manufacturing methods or packaging, and which are authorised and with research subjects who exhibit the same characteristics as the patients for which the medicinal product is authorised. In this case, the following must be added to the original label (the original text must, of course, still be legible): 1 (the name only).
The use of symbols and pictograms is permitted.
Relabeling
In the event of re-labeling due to the expiration date being changed, an additional label must be affixed to the packaging listing the new expiration date and the batch number in accordance with the EU Guidelines to Good Manufacturing Practice for medicinal products for human and veterinary use, Annex 13.
The original information, particularly the batch number and/or the production code, must remain as visible as possible.
General example medicinal product label for the research
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Name of pharmaceutical company (Name of research product) |