Labeling investigational medicinal products

In addition, these guidelines shall lay down adapted provisions relating to labelling for investigational medicinal products intended for clinical trials with the following characteristics ... 

Good Manufacturing Practices (GMP) for study drugs and the provision for a manufacturing licence for investigational medicinal products (IMPs), and labelling requirements... 

Packaging and labelling of investigational medicinal products are likely to be more complex and more liable to errors (which are also harder to detect) than of marketed products when blinded labels are used. Supervision procedures such as label reconciliation, line clearance, etc. and the independent checks by quality control staff should accordingly be intensified. 

In case of use date extension an additional label should be affixed to the investigational medicinal product. This additional label should include the new use date and repeat the batch number. It may be superposed on the old use date, but, for quality control reasons, not on the original batch number. This operation may be performed on site by the clinical trial monitor(s) or the clinical trial site pharmacist, in accordance with specific and standard operating procedures and under contract if applicable. The operation should be checked by a second person. Documented evidence of this additional liability should be available in the trial documentation and in the batch records. 

Chapter IV manufacture, import, labeling of investigational medicinal products. 

The United Kingdom Medicines Act 1968 regulations require that all medicinal products are properly labelled to certain minimum standards, but requirements vary from country to country. Clinical trial materials, however, cannot be labelled normally because if the trial is blind, nothing should reveal to the patient or physician the nature of the contents. The basic information on the label should provide the patient s name, study phase, study number, directions for use, any special warning or storage requirements, expiry date and the investigator s name and address, along with an indication that the... 

Batches should be tailor-made for the proposed trial, and should be labelled with information as appropriate regarding the product, sponsor, investigator, subject and trial, together with the statement For clinical trial use only . In addition, where the medicine will be used outside ofthe clinical site, the statement Keep out of reach of children should be added. There should be full accountability for the distribution, storage and fate of the drug product at both the manufacture and trial sites. 

Herbal drugs may contain additives not listed on the label, and these additives are sometimes the source of the herbal medicine s effect. Investigations by Consumer Reports and others have shown herbal products to contain aspirin, caffeine, steroids, non-steroidal anti-inflammatory drugs, antibiotics, sedatives, and even narcotics. 

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