HO 53a

 

Supplementary memorandum submitted by the Medicines and Healthcare Products Regulatory Agency

 

As part of your evidence check into homeopathy you have asked for details of the label testing on the homeopathic product Arnica and, in particular, what questions were asked during the test and what perceptions of the label were being tested.

As you are aware, homeopathic products authorised under the National Rules Scheme must be labelled in accordance with Articles 54 and 68 of Directive 2001/83 EC as amended. The package leaflet must comply with Article 59 of the Directive and be user tested to ensure that the information is legible, clear and easy to use. However if all of the information required under Article 59 is stated clearly on the label, then a package leaflet may not be included.

 

I would also draw your attention to the European Commission guideline on the readability of the labelling and package leaflet of medicinal products for human use (12 Jan 2009). This can be found at

http://www.emea.europa.eu/htms/human/qrd/qrdguide.htm

 

In the case of Arnica 30C pillules, all of the information required under Article 59 of the Directive could be clearly stated on the label and therefore a separate package leaflet was not required.

 

Three rounds of user testings were carried out with ten participants in each testing. Twelve questions relating to the key safety messages were asked and were designed to assess whether the respondent was able to find the information, understand it and use the information. The questions asked were as follows:

 

1. Can you tell me the name of this medicine?

 

2. What does the label say that this medicine is for?

 

3. If you take too much of this product (overdose) what does the label tell you to do?

 

4. Is there any advice on the label for women who are pregnant or breast feeding?

 

5. What does the label say is the active ingredient in this medicine?

 

6. If you have missed a dose of this medicine, what does the label tell you to do?

 

7. Once you have opened your medicine, how does the leaflet tell you that you should store it?

 

8. This medicine contains Arnica Montana 30C. What are the other ingredients in this medicine?

 

9. How many pillules are there in the Clikpak container?

 

10. This medicine contains lactose and sucrose which are types of sugar. If you have an intolerance to some sugars, what does the pack tell you to do before taking this product?

 

11. How many pillules does the pack say that you should take in a dose and how many times a day should you take them?

 

12. The pillules in this medicine are contained in a plastic Clikpak to help protect them. What instructions does the label give you as to how to dispense the pillules from the Clikpak?

 

Participants' answers were provided and the ease with which the information was located was graded as very easily; easily; little difficulty or lots of difficulty. Assessment of understanding the information was graded as yes or no. Some issues raised with the early user tests have been satisfactorily addressed in the subsequent user test. Participants were also asked to comment on the layout and design of the label and the response was positive, indicating that the label was well structured and easy to read. Overall and on each occasion, a satisfactory test outcome was achieved meeting the success criteria i.e. 90% of participants were able to find the information requested, of whom 90% could show that they understood the information by providing the correct answer and it was concluded that no further user testing was required.

 

Professor Kent Woods

CEO

 

 

December 2009